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| ID | Type | Description | Link |
|---|---|---|---|
| R44DK107231 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Integrated Medical Development | INDUSTRY |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Pharmaceutical Research Associates | OTHER |
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This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose safety and tolerability study of EXT608 in healthy subjects. There will be up to 6 sequential dose escalation cohorts of 4 participants. In each cohort 3 participants will receive EXT608 and 1 participant will receive placebo.
This is a randomized, double-blind, first-in-human, placebo-controlled single ascending dose study to study the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EXT608 in healthy adult participants.
Participants will be enrolled into 1 of up to 6 planned single dose cohorts in ascending fashion.
Each cohort will consist of 4 participants randomized to receive either EXT608 or placebo, whereby 3 will receive a single injection of EXT608 and 1 will receive matching placebo.
Up to 6 dosing cohorts are planned with no single dose escalation to exceed a 3-fold dose increment. A Data Monitoring Board will review the seven-day safety data in each cohort before authorizing the initiation of the next cohort.
A screening visit will take place within 28 days of dosing. Eligible participants for each cohort will be admitted to the Clinical Research Unit (CRU) 1 day prior to dosing and remain in the CRU through at least 72 hours after dosing for safety and PK assessments before discharge. The total confinement period will be 4 nights, unless extended for management of Adverse Events (AEs) at the discretion of the Investigator
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental- EXT608 | Experimental | Up to 6 sequential dose escalation cohorts will receive a single dose of EXT608 administered as a subcutaneous injection |
|
| Placebo comparator | Placebo Comparator | Up to 6 participants will receive matching placebo administered as a subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXT608 | Drug | EXT608 is an investigational drug administered via subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the Safety and Tolerability of EXT608 | Incidence, nature and severity of adverse events (AEs) and withdrawals due to Treatment-Emergent Adverse Events (TEAEs) | Day 0 to Day 28 |
| Characterize the Safety and Tolerability of EXT608 | Frequency and severity of post-dose change from baseline of hematology, serum chemistry, urinalysis, electrocardiogram (ECG), vital signs and physical examination findings | Day 0 - Day 28 |
| Characterize the Safety and Tolerability of EXT608 | Percentage of participants with injection or infusion site reactions - edema | Day 0 - Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Single Dose Pharmacokinetics (PK) - Area Under the Curve (AUC) | Area under the curve | Day 0 to Day 7 |
| Single Dose PK - Cmax | Maximum observed concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Hales, PhD | Extend Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA | Lenexa | Kansas | 66219 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Comparator | Six participants (one per cohort) received matching placebo administered as a subcutaneous injection |
| FG001 | Experimental- EXT608 4ug | Cohort 1: 4 ug Three participants received a single dose of EXT608 administered as a subcutaneous injection |
| FG002 | Experimental- EXT608 12 ug | Cohort 2: 12 ug Three participants received a single dose of EXT608 administered as a subcutaneous injection |
| FG003 | Experimental- EXT608 36 ug | Cohort 3: 36 ug Three participants received a single dose of EXT608 administered as a subcutaneous injection |
| FG004 | Experimental- EXT608 108 ug | Cohort 4: 108 ug Three participants received a single dose of EXT608 administered as a subcutaneous injection |
| FG005 | Experimental- EXT608 324 ug | Cohort 5: 324 ug Three participants received a single dose of EXT608 administered as a subcutaneous injection |
| FG006 | Experimental- EXT608 216 ug | Cohort 6: 216 ug Three participants received a single dose of EXT608 administered as a subcutaneous injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Comparator | Six participants (one per cohort) received matching placebo administered as a subcutaneous injection |
| BG001 | Experimental- EXT608 4ug | Three participants received a single dose of EXT608 administered as a subcutaneous injection |
| 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 |
| 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 | Characterize the Safety and Tolerability of EXT608 | Incidence, nature and severity of adverse events (AEs) and withdrawals due to Treatment-Emergent Adverse Events (TEAEs) | Posted | Count of Participants | Participants | Day 0 to Day 28 |
|
28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Comparator | Six participants (1 participant in each of 6 sequential dose escalation cohorts) received matching placebo administered as a subcutaneous injection |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Hales PhD | Extend Biosciences | (732) 599-8581 | lhales@extendbio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 24, 2022 | Nov 27, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 4, 2023 | Nov 27, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 25, 2022 | Nov 27, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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Single ascending dose with up to 6 sequential dose escalation cohorts. Participants will be randomized to either study intervention (EXT608) or placebo
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Double (Participant, investigator)
| Placebo | Other | matching placebo administered via subcutaneous injection |
|
| 0-24 hr |
| Single Dose PK - Tmax | Time to reach maximum observed plasma concentration | Day 0 to Day 7 |
| BG002 | Experimental- EXT608 12 ug | Three participants received a single dose of EXT608 administered as a subcutaneous injection |
| BG003 | Experimental- EXT608 36ug | Three participants received a single dose of EXT608 administered as a subcutaneous injection |
| BG004 | Experimental- EXT608 108ug | Three participants received a single dose of EXT608 administered as a subcutaneous injection |
| BG005 | Experimental- EXT608 324ug | Three participants received a single dose of EXT608 administered as a subcutaneous injection |
| BG006 | Experimental- EXT608 216ug | Three participants received a single dose of EXT608 administered as a subcutaneous injection |
| BG007 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Experimental - EXT608 12 ug |
Cohort 2: Three participants received a single dose of EXT608 administered as a subcutaneous injection |
| OG003 | Experimental - EXT608 36 ug | Cohort 3: Three participants received a single dose of EXT608 administered as a subcutaneous injection |
| OG004 | Experimental - EXT608 108 ug | Cohort 4: Three participants received a single dose of EXT608 administered as a subcutaneous injection |
| OG005 | Experimental - EXT608 324 ug | Cohort 5: Three participants received a single dose of EXT608 administered as a subcutaneous injection |
| OG006 | Experimental - EXT608 216 ug | Cohort 6: Three participants received a single dose of EXT608 administered as a subcutaneous injection |
|
|
| Primary | Characterize the Safety and Tolerability of EXT608 | Frequency and severity of post-dose change from baseline of hematology, serum chemistry, urinalysis, electrocardiogram (ECG), vital signs and physical examination findings | Posted | Count of Participants | Participants | Day 0 - Day 28 |
|
|
|
| Primary | Characterize the Safety and Tolerability of EXT608 | Percentage of participants with injection or infusion site reactions - edema | Posted | Count of Participants | Participants | Day 0 - Day 28 |
|
|
|
| Secondary | Single Dose Pharmacokinetics (PK) - Area Under the Curve (AUC) | Area under the curve | Posted | Mean | Standard Deviation | pg*Day/mL | Day 0 to Day 7 |
|
|
|
| Secondary | Single Dose PK - Cmax | Maximum observed concentration | Posted | Mean | Standard Deviation | pg/mL | 0-24 hr |
|
|
|
| Secondary | Single Dose PK - Tmax | Time to reach maximum observed plasma concentration | Posted | Mean | Standard Deviation | hr | Day 0 to Day 7 |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | Experimental- EXT608 4 ug | Cohort 1: Three participants received a single dose of EXT608 administered as a subcutaneous injection | 0 | 3 | 0 | 3 | 2 | 3 |
| EG002 | Experimental- EXT608 12 ug | Cohort 2: Three participants received a single dose of EXT608 administered as a subcutaneous injection | 0 | 3 | 0 | 3 | 1 | 3 |
| EG003 | Experimental- EXT608 36 ug | Cohort 3: Three participants received a single dose of EXT608 administered as a subcutaneous injection | 0 | 3 | 0 | 3 | 0 | 3 |
| EG004 | Experimental- EXT608 108 ug | Cohort 4: Three participants received a single dose of EXT608 administered as a subcutaneous injection | 0 | 3 | 0 | 3 | 2 | 3 |
| EG005 | Experimental- EXT608 324 ug | Cohort 5: Three participants received a single dose of EXT608 administered as a subcutaneous injection | 0 | 3 | 0 | 3 | 2 | 3 |
| EG006 | Experimental- EXT608 216 ug | Cohort 7: Three participants received a single dose of EXT608 administered as a subcutaneous injection | 0 | 3 | 0 | 3 | 0 | 3 |
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Non-systematic Assessment |
|
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