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| ID | Type | Description | Link |
|---|---|---|---|
| STX-003 | Other Identifier | Stromedix, Inc. |
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The primary objective of this study is to evaluate the safety and tolerability of subcutaneously (SC) administered multiple, escalating doses of BG00011 (a humanized monoclonal antibody directed against the alpha v beta 6 (αvβ6) integrin, formerly known as STX-100) in participants with IPF. The Secondary objectives are to estimate the pharmacokinetic (PK) parameters after the 1st dose and after the last dose of multiple, escalating doses of BG00011 in participants with IPF, to assess the immunogenicity of BG00011 in participants with IPF, and to assess the effect of BG00011 on biomarkers isolated from bronchoalveolar lavage (BAL) and peripheral blood in participants with IPF.
This study was previously posted by Stromedix, Inc. In April, 2014, sponsorship of the trial was transferred to Biogen. The study drug name was changed from STX-100 to BG00011 and the study number was changed from STX-003 to 203PF201, to align with sponsor conventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BG00011 | Experimental | Participants will receive 8 consecutive weekly doses of BG00011 |
|
| Placebo | Placebo Comparator | Participants will receive 8 consecutive weekly doses of placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BG00011 | Drug | BG00011 will be administered at varying doses via subcutaneous (SC) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. | up to Week 19 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Observed Serum Concentration (Tmax) of BG00011 | Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 | |
| Maximum Observed Serum Concentration (Cmax) of BG00011 |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion Criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | San Francisco | California | 94143 | United States | ||
| Research Site |
Forty-one participants were randomized and received at least one dose in the study.
The participants were enrolled across 10 sites in the US.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BG00011 0.015 mg | Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses. |
| FG001 | BG00011 0.1 mg | Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses. |
| FG002 | BG00011 0.3 mg | Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses. |
| FG003 | BG00011 1.0 mg | Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses. |
| FG004 | BG00011 3.0 mg | Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses. |
| FG005 | Matching Placebo | Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population: The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo.
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| ID | Title | Description |
|---|---|---|
| BG000 | BG00011 0.015 mg | Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses. |
| BG001 | BG00011 0.1 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 With Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. | The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. | Posted | Number | Participants | up to Week 19 |
|
Up to Week 19
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo.
The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
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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 | BG00011 0.015 mg | Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular Block Complete | Cardiac disorders | MedDRA Version 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Pain | General disorders | MedDRA Version 20.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Biogen Study Medical Director | Biogen | 866-633-4636 | clinicaltrials@biogen.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 23, 2016 | Feb 12, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 16, 2015 | Feb 12, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Placebo | Drug | Sterile normal saline (0.9% Sodium Chloride for Injection) via Subcutaneous (SC) injections. |
|
| Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 |
| Area Under the Serum Concentration Time Curve From Time 0 to Last Quantifiable Observed Concentration AUC(0-t) of BG00011 | Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 |
| Area Under the Serum Concentration-Time Curve From Time 0 to 168 Hours AUC(0-168) of BG00011 | Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 |
| Apparent Terminal Elimination Half Life (T1/2) of BG00011 | Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 |
| Apparent Terminal Rate Constant [λz] | Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 |
| Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-inf) of BG00011 | Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 |
| Apparent Clearance (CL/F) of BG00011 | Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 |
| Apparent Volume of Distribution (Vd/F) of BG00011 | Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 |
| Percentage Change (PC) From Baseline in Biomarkers Isolated From Bronchoalveolar Lavage (BAL) | The expression level of 7 genes; Arachidonate 5-lipoxygenase (ALOX5), fibronectin 1 (FN1), Oxidized low density lipoprotein receptor 1 (OLR1), Plasminogen activator inhibitor-1 (PAI-1; aka SERPINE 1), Transglutaminase 2 (TGM2), Triggering receptor expressed on myeloid cells 1 (TREM1), and v-ets erythroblastosis virus E26 oncogene homolog 1 (ETS1) were assessed via BAL as well as a ratio of pSMAD2 to tSMAD2 levels. | Baseline, Day 8 (Follow up) |
| Number of Participants With Treatment Emergent Antibodies to BG00011 | Up to Week 19 |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Research Site | Kansas City | Kansas | 66160 | United States |
| Research Site | Boston | Massachusetts | 02114 | United States |
| Research Site | Boston | Massachusetts | 02115 | United States |
| Research Site | Lebanon | New Hampshire | 03756 | United States |
| Research Site | Cleveland | Ohio | 44195 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Research Site | Nashville | Tennessee | 37232 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Study terminated by sponsor |
|
| Subject request |
|
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
| BG002 | BG00011 0.3 mg | Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses. |
| BG003 | BG00011 1.0 mg | Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses. |
| BG004 | BG00011 3.0 mg | Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses. |
| BG005 | Matching Placebo | Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.
| OG002 | BG00011 0.3 mg | Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses. |
| OG003 | BG00011 1.0 mg | Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses. |
| OG004 | BG00011 3.0 mg | Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses. |
| OG005 | Matching Placebo | Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses. |
|
|
| Secondary | Time to Reach Maximum Observed Serum Concentration (Tmax) of BG00011 | Pharmacokinetic (PK) population = Safety population. | Posted | Mean | Standard Deviation | hours | Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 |
|
|
|
| Secondary | Maximum Observed Serum Concentration (Cmax) of BG00011 | PK population = Safety population. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 |
|
|
|
| Secondary | Area Under the Serum Concentration Time Curve From Time 0 to Last Quantifiable Observed Concentration AUC(0-t) of BG00011 | PK population = Safety population. | Posted | Mean | Standard Deviation | hours nanogram per milliliter (hr*ng/mL) | Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 |
|
|
|
| Secondary | Area Under the Serum Concentration-Time Curve From Time 0 to 168 Hours AUC(0-168) of BG00011 | PK population = Safety population. | Posted | Mean | Standard Deviation | hr*ng/mL | Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 |
|
|
|
| Secondary | Apparent Terminal Elimination Half Life (T1/2) of BG00011 | PK population = Safety population. Data for this outcome measure was not collected at Day 1. | Posted | Mean | Standard Deviation | hour | Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 |
|
|
|
| Secondary | Apparent Terminal Rate Constant [λz] | PK population = Safety population. Data for this outcome measure was not collected at Day 1. | Posted | Mean | Standard Deviation | hour | Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 |
|
|
|
| Secondary | Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-inf) of BG00011 | PK population = Safety population. Data for this outcome measure was not collected at Day 1. | Posted | Mean | Standard Deviation | hr*ng/mL | Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 |
|
|
|
| Secondary | Apparent Clearance (CL/F) of BG00011 | PK population = Safety population. Data for this outcome measure was not collected at Day 1. | Posted | Mean | Standard Deviation | milliliter/hour/kilogram (mL/hr/kg) | Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 |
|
|
|
| Secondary | Apparent Volume of Distribution (Vd/F) of BG00011 | PK population = safety population. Data for this outcome measure was not analysed on day 1. | Posted | Mean | Standard Deviation | milliliter per kilogram (mL/kg) | Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 |
|
|
|
| Secondary | Percentage Change (PC) From Baseline in Biomarkers Isolated From Bronchoalveolar Lavage (BAL) | The expression level of 7 genes; Arachidonate 5-lipoxygenase (ALOX5), fibronectin 1 (FN1), Oxidized low density lipoprotein receptor 1 (OLR1), Plasminogen activator inhibitor-1 (PAI-1; aka SERPINE 1), Transglutaminase 2 (TGM2), Triggering receptor expressed on myeloid cells 1 (TREM1), and v-ets erythroblastosis virus E26 oncogene homolog 1 (ETS1) were assessed via BAL as well as a ratio of pSMAD2 to tSMAD2 levels. | The "Pharmacodynamic" population consisted of all participants who received at least 1 multiple dose injection of BG00011 and have a corresponding sample collected for BAL and/or blood biomarkers. | Posted | Mean | Standard Deviation | Percentage | Baseline, Day 8 (Follow up) |
|
|
|
| Secondary | Number of Participants With Treatment Emergent Antibodies to BG00011 | The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. | Posted | Number | participants | Up to Week 19 |
|
|
|
| 0 |
| 6 |
| 1 |
| 6 |
| 6 |
| 6 |
| EG001 | BG00011 0.1 mg | Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG002 | BG00011 0.3 mg | Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG003 | BG00011 1.0 mg | Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses. | 1 | 7 | 2 | 7 | 4 | 7 |
| EG004 | BG00011 3.0 mg | Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses. | 0 | 6 | 1 | 6 | 6 | 6 |
| EG005 | Matching Placebo | Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses. | 0 | 10 | 0 | 10 | 10 | 10 |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Idiopathic Pulmonary Fibrosis Exacerbation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Type II Second-Degree Atrioventricular Block | Cardiac disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Viral Infection | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Hepatic Enzyme Increased | Investigations | MedDRA Version 20.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Idiopathic Pulmonary Fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Phlebitis Superficial | Vascular disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Viral Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Upper-Airway Cough Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Increased Bronchial Secretion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Lung Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Nasal Discharge Discoloration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Sleep Apnoea Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Sputum Discolored | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Chest Discomfort | General disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Infusion Site Bruising | General disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Injection Site Erythema | General disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Injection Site Paraesthesia | General disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Vessel Puncture Site Pain | General disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Acute Sinusitis | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Genital Herpes | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Blood Lactate Dehydrogenase Increased | Investigations | MedDRA Version 20.0 | Systematic Assessment |
|
| Blood Pressure Increased | Investigations | MedDRA Version 20.0 | Systematic Assessment |
|
| Electrocardiogram Qt Prolonged | Investigations | MedDRA Version 20.0 | Systematic Assessment |
|
| Glucose Urine Present | Investigations | MedDRA Version 20.0 | Systematic Assessment |
|
| Oxygen Saturation Decreased | Investigations | MedDRA Version 20.0 | Systematic Assessment |
|
| Protein Urine Present | Investigations | MedDRA Version 20.0 | Systematic Assessment |
|
| Total Lung Capacity Decreased | Investigations | MedDRA Version 20.0 | Systematic Assessment |
|
| Urine Analysis Abnormal | Investigations | MedDRA Version 20.0 | Systematic Assessment |
|
| Urine Leukocyte Esterase Positive | Investigations | MedDRA Version 20.0 | Systematic Assessment |
|
| Cardiac Murmur | Investigations | MedDRA Version 20.0 | Systematic Assessment |
|
| Pulmonary Function Test Decreased | Investigations | MedDRA Version 20.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Muscle Fatigue | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Sensitivity of Teeth | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Umbilical Hernia | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Skin Lesion | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Bone Contusion | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Jaw Fracture | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Limb Injury | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Procedural Complication | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Tooth Fracture | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Eye Contusion | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Thinking Abnormal | Psychiatric disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Atrioventricular Block Complete | Cardiac disorders | MedDRA Version 20.0 | Systematic Assessment |
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| Atrioventricular Block Second Degree | Cardiac disorders | MedDRA Version 20.0 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA Version 20.0 | Systematic Assessment |
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| Seasonal Allergy | Immune system disorders | MedDRA Version 20.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 20.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA Version 20.0 | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA Version 20.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA Version 20.0 | Systematic Assessment |
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| Squamous Cell Carcinoma of Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.0 | Systematic Assessment |
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Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
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| FN1; PC at Day 8 (Follow Up) |
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| OLR1; PC at Day 8 (Follow Up) |
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| PAI-1; aka SERPINE 1; PC at Day 8 (Follow Up) |
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| TGM2; PC at Day 8 (Follow Up) |
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| TREM1; PC at Day 8 (Follow Up) |
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| ETS1; PC at Day 8 (Follow Up) |
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| pSMAD2 to tSMAD2; PC at Day 8 (Follow Up) |
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