Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005303-24 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the long-term safety of MT10109L in the treatment of GL and/or LCL in participants with moderate to severe GL and/or LCL.
Study MT10109L-004 is an open-label extension involving participants from studies MT10109L-001 (NCT03795922), -002 (NCT03785145), -005 (NCT03721016), and -006 (NCT03732833) (referred to as Lead-In studies). The objective is to evaluate long term safety of MT10109L. Participants will include those who completed the global lead-in studies and meet the eligibility criteria for entering this open-label extension study.
Participants who meet retreatment criteria will receive MT10109L administered in the same treatment area(s) with the same number of injections and injection sites as in their lead-in studies.
The safety and efficacy data from the lead-in and this open-label extension will be summarized.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo/MT10109L Dose 1 | Experimental | The participant pool in this arm are from the MT10109L-001 lead-in study (NCT03795922), who received Placebo in period 1 and MT10109L Dose 1 in period 2. Eligible participants from this study continue receiving Dose 1 in the open-label MT10109L-004 study |
|
| Placebo/MT10109L Dose 2 | Experimental | The participant pool in this arm are from the MT10109L-002 lead-in study (NCT03785145), who received Placebo in period 1 and MT10109L Dose 2 in period 2. Eligible participants from this study continue receiving Dose 2 in the open-label MT10109L-004 study. |
|
| Placebo/MT10109L Dose 1 + Dose 2 | Experimental | The participant pool in this arm are from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 & 2. Eligible participants from this study receives Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. |
|
| MT10109L Dose 1/Dose 1 | Experimental | The participant pool in this arm are from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continue receiving Dose 1 in the open-label MT10109L-004 study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT10109L Dose 1 | Drug | MT10109L Dose 1 will be injected into the GL area |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Any Adverse Event (AE) | The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit. | Baseline to Day 720 or Study Exit |
| Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs) | This section focuses primarily on Treatment-Related (Study drug or procedure) Adverse Events(TEAEs). TEAEs are AEs with onset date on or after first dose of study intervention (placebo or MT10109L) in the pivotal study and ≤ 30 days after the study exit visit in the extension study. | Baseline to Day 720 or Study exit |
| Mean Change From Baseline in Pulse Rate (Beats Per Minute) | The outcome reported here is the mean change in pulse rate from baseline to study exit. | Baseline to Day 720 or Study Exit |
| Mean Change From Baseline in Systolic Blood Pressure (mm Hg) | The outcome reported here is the mean change in Systolic BP from baseline to study exit. | Baseline to Day 720 or Study Exit |
| Mean Change From Baseline in Diastolic Blood Pressure (mm Hg) | The outcome reported here is the mean change in Diastolic BP from baseline to study exit. | Baseline to Day 720 or Study Exit |
| Mean Change From Baseline in Respiratory Rate (Breaths Per Minute) | The outcome reported here is the mean change in respiratory rate from baseline to study exit. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| SangMi Park | Medytox Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clear Dermatology & Aesthetics Center | Scottsdale | Arizona | 85255-4134 | United States | ||
| The Eye Research Foundation |
Not provided
Not provided
Not provided
Not provided
Not provided
Study MT10109L-004 is an open-label extension involving participants from studies MT10109L-001 (NCT03795922), -002 (NCT03785145), -005 (NCT03721016), and -006(NCT03732833) (referred to as Lead-In studies). Participants from the lead-in studies, who met the eligibility criteria, were enrolled to continue receiving additional cycles of MT10109L in their respective treatment areas (Glabellar area or Lateral Canthal Lines area).
Approximately 800 participants were planned to be enrolled. A total of 957 participants were enrolled and treated, and 759 participants completed the study. There were 957 participants in the intent-to-treat (ITT) population, which were used for the efficacy of US FDA and safety analyses.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/MT10109L Dose 1 | The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received Placebo in period 1 and MT10109L Dose 1 in period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 1, 2022 | Jun 19, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| MT10109L Dose 2/Dose 2 | Experimental | The participant pool in this arm are from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continue receiving Dose 2 in the open-label MT10109L-004 study. |
|
| MT10109L Dose 1/Dose 1+2 | Experimental | The participant pool in this arm are from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study receives Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. |
|
| MT10109L Dose 2/Dose 1+2 | Experimental | The participant pool in this arm are from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study receives Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. |
|
| MT10109L Dose 1+2/Dose 1+2 | Experimental | The participant pool in this arm are from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 & 2. Eligible participants from this study receives Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. |
|
| MT10109L Dose 2 | Drug | MT10109L Dose 2 will be injected into the LCL area |
|
| MT10109L Dose 1 + Dose 2 | Drug | MT10109L Dose 1 will be injected into the GL area plus MT10109L Dose 2 will be injected into the LCL area |
|
| Baseline to Day 720 or Study Exit |
| Number of Participants With Binding and Neutralizing Antibodies | Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown. | Baseline to Day 720 or Study Exit |
| Newport Beach |
| California |
| 92663-3637 |
| United States |
| Art of Skin MD | Solana Beach | California | 92075-2228 | United States |
| Susan H. Weinkle | Bradenton | Florida | 34209-5642 | United States |
| Skin Research Institute | Coral Gables | Florida | 33146-1837 | United States |
| Coleman Center For Cosmetic Dermatologic Surgery | Metairie | Louisiana | 70006 | United States |
| Etre Cosmetic Dermatology and Laser Center | New Orleans | Louisiana | 70130-4353 | United States |
| MD Laser Skin & Vein | Hunt Valley | Maryland | 21030 | United States |
| Laser & Skin Surgery Center of New York | New York | New York | 10016-4974 | United States |
| Skin Search of Rochester Inc. | Rochester | New York | 14623 | United States |
| M3 Wake Research Inc. | Raleigh | North Carolina | 27612-8106 | United States |
| Wilmington Dermatology Center | Wilmington | North Carolina | 28403 | United States |
| Aventiv Research Dublin | Dublin | Ohio | 43016 | United States |
| Westlake Dermatology & Cosmetic Surgery - Westlake | Austin | Texas | 78746-4720 | United States |
| DermResearch Inc. | Austin | Texas | 78759 | United States |
| Bellaire Dermatology | Bellaire | Texas | 77401 | United States |
| SkinDC | Arlington | Virginia | 22209 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23507 | United States |
| UZ Brussel | Jette | Brussels Capital | 1090 | Belgium |
| Medical Skincare | Sint-Truiden | Limburg | 3800 | Belgium |
| Dr. Shannon Humphrey Inc. | Vancouver | British Columbia | V5Z 4E1 | Canada |
| Project Skin MD LTD | Vancouver | British Columbia | V6H 1K9 | Canada |
| Pacific Derm | Vancouver | British Columbia | V6H 4E1 | Canada |
| Dermetics Cosmetic Dermatology | Burlington | Ontario | L7N 3N2 | Canada |
| The Center For Dermatology | Richmond Hill | Ontario | L4B 1A5 | Canada |
| Sweat Clinics of Canada | Toronto | Ontarion | M5R 3N8 | Canada |
| Rosenpark Research | Darmstadt | 64283 | Germany |
| Privatpraxis Dr. Hilton & Partner | Düsseldorf | 40212 | Germany |
| Hautok and Hautok-cosmetics | München | 80333 | Germany |
| Studienzentrum Theatiner46 | München | 80333 | Germany |
| MediCorium Zentrum fuer Dermatologie und Aesthetik | Oberursel | 61440 | Germany |
| Kazan State Medical University | Kazan' | 420012 | Russia |
| Medical Center Capital - Zdorovie LLC | Moscow | 109369 | Russia |
| Center dermatovenereology and cosmetology | Moscow | 119071 | Russia |
| State Budget Institution of Higher Education North | Saint Petersburg | 194291 | Russia |
| Meyer Clinic | Chichester | PO18 8AN | United Kingdom |
| NHS Lanarkshire | Glasgow | G71 8BB | United Kingdom |
| MediZen Premier Aesthetic Clinic | Sutton Coldfield | B74 2UG | United Kingdom |
| FG001 |
| Placebo/MT10109L Dose 2 |
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received Placebo in period 1 and MT10109L Dose 2 in period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study. MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area. |
| FG002 | Placebo/MT10109L Dose 1 + Dose 2 | The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 & 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. |
| FG003 | MT10109L Dose 1/Dose 1 | The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study. MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area |
| FG004 | MT10109L Dose 2/Dose 2 | The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study. MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area. |
| FG005 | MT10109L Dose 1/Dose 1+2 | The participant pool in this arm were from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. |
| FG006 | MT10109L Dose 2/Dose 1+2 | The participant pool in this arm were from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area |
| FG007 | MT10109L Dose 1+2/Dose 1+2 | The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 & 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants pool in this open-label extension study flowed from studies MT10109L-001 (NCT03795922), -002 (NCT03785145), -005 (NCT03721016), and -006 (NCT03732833) (referred to as Lead-In studies). 957 participants were included in the Intent-To-Treat (ITT) population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/MT10109L Dose 1 | The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received Placebo in period 1 and MT10109L Dose 1 in period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area. |
| BG001 | Placebo/MT10109L Dose 2 | The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received Placebo in period 1 and MT10109L Dose 2 in period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study. MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area. |
| BG002 | Placebo/MT10109L Dose 1 + Dose 2 | The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 & 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. |
| BG003 | MT10109L Dose 1/Dose 1 | The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study. MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area |
| BG004 | MT10109L Dose 2/Dose 2 | The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study. MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area. |
| BG005 | MT10109L Dose 1/Dose 1+2 | The participant pool in this arm were from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. |
| BG006 | MT10109L Dose 2/Dose 1+2 | The participant pool in this arm were from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area |
| BG007 | MT10109L Dose 1+2/Dose 1+2 | The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 & 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced Any Adverse Event (AE) | The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit. | All safety analyses were carried out using the ITT population, which was defined as all participants who enrolled in Study MT10109L-004 and received at least 1 intervention (MT10109L or placebo) in their prior Phase 3 study (MT10109L-001, -002, -005, or -006) or in the current study. | Posted | Count of Participants | Participants | Baseline to Day 720 or Study Exit |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs) | This section focuses primarily on Treatment-Related (Study drug or procedure) Adverse Events(TEAEs). TEAEs are AEs with onset date on or after first dose of study intervention (placebo or MT10109L) in the pivotal study and ≤ 30 days after the study exit visit in the extension study. | All safety analyses were carried out using the ITT population, which was defined as all participants who enrolled in Study MT10109L-004 and received at least 1 intervention (MT10109L or placebo) in their prior Phase 3 study (MT10109L-001, -002, -005, or -006) or in the current study. | Posted | Count of Participants | Participants | Baseline to Day 720 or Study exit |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline in Pulse Rate (Beats Per Minute) | The outcome reported here is the mean change in pulse rate from baseline to study exit. | All safety analyses were carried out using the ITT population, which was defined as all participants who enrolled in Study MT10109L-004 and received at least 1 intervention (MT10109L or placebo) in their prior Phase 3 study (MT10109L-001, -002, -005, or -006) or in the current study. The final outcome measure data reported here are the mean change measured among the participants at day 720 or study exit. | Posted | Mean | Standard Deviation | beats/min | Baseline to Day 720 or Study Exit |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline in Systolic Blood Pressure (mm Hg) | The outcome reported here is the mean change in Systolic BP from baseline to study exit. | All safety analyses were carried out using the ITT population, which was defined as all participants who enrolled in Study MT10109L-004 and received at least 1 intervention (MT10109L or placebo) in their prior Phase 3 study (MT10109L-001, -002, -005, or -006) or in the current study. The final outcome measure data reported here are the mean change measured among the participants at day 720 or study exit. | Posted | Mean | Standard Deviation | mmHg | Baseline to Day 720 or Study Exit |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline in Diastolic Blood Pressure (mm Hg) | The outcome reported here is the mean change in Diastolic BP from baseline to study exit. | All safety analyses were carried out using the ITT population, which was defined as all participants who enrolled in Study MT10109L-004 and received at least 1 intervention (MT10109L or placebo) in their prior Phase 3 study (MT10109L-001, -002, -005, or -006) or in the current study. The final outcome measure data reported here are the mean change measured among the participants at day 720 or study exit. | Posted | Mean | Standard Deviation | mmHg | Baseline to Day 720 or Study Exit |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline in Respiratory Rate (Breaths Per Minute) | The outcome reported here is the mean change in respiratory rate from baseline to study exit. | All safety analyses were carried out using the ITT population, which was defined as all participants who enrolled in Study MT10109L-004 and received at least 1 intervention (MT10109L or placebo) in their prior Phase 3 study (MT10109L-001, -002, -005, or -006) or in the current study. The final outcome measure data reported here are the mean change measured among the participants at day 720 or study exit. | Posted | Mean | Standard Deviation | breaths/min | Baseline to Day 720 or Study Exit |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Binding and Neutralizing Antibodies | Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown. | Posted | Count of Participants | Participants | Baseline to Day 720 or Study Exit |
|
The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if:
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo/MT10109L Dose 1 | The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received Placebo in period 1 and MT10109L Dose 1 in period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area. | 0 | 55 | 3 | 55 | 26 | 55 |
| EG001 | Placebo/MT10109L Dose 2 | The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received Placebo in period 1 and MT10109L Dose 2 in period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study. MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area. | 0 | 56 | 1 | 56 | 23 | 56 |
| EG002 | Placebo/MT10109L Dose 1 + Dose 2 | The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 & 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. | 0 | 118 | 10 | 118 | 58 | 118 |
| EG003 | MT10109L Dose 1/Dose 1 | The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study. MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area | 2 | 116 | 8 | 116 | 54 | 116 |
| EG004 | MT10109L Dose 2/Dose 2 | The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study. MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area. | 0 | 108 | 9 | 108 | 45 | 108 |
| EG005 | MT10109L Dose 1/Dose 1+2 | The participant pool in this arm were from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. | 0 | 128 | 7 | 128 | 50 | 128 |
| EG006 | MT10109L Dose 2/Dose 1+2 | The participant pool in this arm were from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area | 0 | 123 | 13 | 123 | 60 | 123 |
| EG007 | MT10109L Dose 1+2/Dose 1+2 | The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 & 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. | 0 | 253 | 13 | 253 | 128 | 253 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Allergy to arthropod sting | Immune system disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA, Version 24.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Endometritis | Infections and infestations | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 24.1 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Basosquamous carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Bone cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Breast cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Hormone receptor positive breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Superficial spreading melanoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA, Version 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA, Version 24.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA, Version 24.1 | Systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA, Version 24.1 | Systematic Assessment |
|
General research agreement between the sponsor and PI's that includes a confidentiality section that includes a statement that the sponsor is and shall remain the exclusive owner of 'Information'. 'Information' shall include, but shall not be limited to, protocols, trade secrets, know-how, formulations, inventions, techniques, equipment, data and results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Young Ryu | Medytox Inc. | +82-2-6901-5424 | aab005@medytox.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 14, 2023 | Jun 19, 2024 | SAP_001.pdf |
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Placebo/MT10109L Dose 1 + Dose 2 | The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 & 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. |
| OG003 | MT10109L Dose 1/Dose 1 | The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study. MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area |
| OG004 | MT10109L Dose 2/Dose 2 | The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study. MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area. |
| OG005 | MT10109L Dose 1/Dose 1+2 | The participant pool in this arm were from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. |
| OG006 | MT10109L Dose 2/Dose 1+2 | The participant pool in this arm were from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area |
| OG007 | MT10109L Dose 1+2/Dose 1+2 | The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 & 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. |
|
|
| OG002 |
| Placebo/MT10109L Dose 1 + Dose 2 |
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 & 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. |
| OG003 | MT10109L Dose 1/Dose 1 | The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study. MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area |
| OG004 | MT10109L Dose 2/Dose 2 | The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study. MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area. |
| OG005 | MT10109L Dose 1/Dose 1+2 | The participant pool in this arm were from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. |
| OG006 | MT10109L Dose 2/Dose 1+2 | The participant pool in this arm were from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area |
| OG007 | MT10109L Dose 1+2/Dose 1+2 | The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 & 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. |
|
|
| OG002 |
| Placebo/MT10109L Dose 1 + Dose 2 |
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 & 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. |
| OG003 | MT10109L Dose 1/Dose 1 | The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study. MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area |
| OG004 | MT10109L Dose 2/Dose 2 | The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study. MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area. |
| OG005 | MT10109L Dose 1/Dose 1+2 | The participant pool in this arm were from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. |
| OG006 | MT10109L Dose 2/Dose 1+2 | The participant pool in this arm were from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area |
| OG007 | MT10109L Dose 1+2/Dose 1+2 | The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 & 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. |
|
|
| OG002 |
| Placebo/MT10109L Dose 1 + Dose 2 |
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 & 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. |
| OG003 | MT10109L Dose 1/Dose 1 | The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study. MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area |
| OG004 | MT10109L Dose 2/Dose 2 | The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study. MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area. |
| OG005 | MT10109L Dose 1/Dose 1+2 | The participant pool in this arm were from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. |
| OG006 | MT10109L Dose 2/Dose 1+2 | The participant pool in this arm were from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area |
| OG007 | MT10109L Dose 1+2/Dose 1+2 | The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 & 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. |
|
|
| OG002 |
| Placebo/MT10109L Dose 1 + Dose 2 |
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 & 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. |
| OG003 | MT10109L Dose 1/Dose 1 | The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study. MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area |
| OG004 | MT10109L Dose 2/Dose 2 | The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study. MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area. |
| OG005 | MT10109L Dose 1/Dose 1+2 | The participant pool in this arm were from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. |
| OG006 | MT10109L Dose 2/Dose 1+2 | The participant pool in this arm were from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area |
| OG007 | MT10109L Dose 1+2/Dose 1+2 | The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 & 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. |
|
|
| OG003 | MT10109L Dose 1/Dose 1 | The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study. MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area |
| OG004 | MT10109L Dose 2/Dose 2 | The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study. MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area. |
| OG005 | MT10109L Dose 1/Dose 1+2 | The participant pool in this arm were from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. |
| OG006 | MT10109L Dose 2/Dose 1+2 | The participant pool in this arm were from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area |
| OG007 | MT10109L Dose 1+2/Dose 1+2 | The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 & 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study. MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area. |
|
|