Phase 1 SAD and MAD Study of NGM282 in Healthy Adult Participants
Phase 1
Completed
- Conditions
- Diabetes Mellitus
- Interventions
- Biological: NGM282Biological: Placebo
- Registration Number
- NCT01776528
- Lead Sponsor
- NGM Biopharmaceuticals, Inc
- Brief Summary
The purpose of this study is to determine the safety and tolerability of NGM282, both single dose and multiple doses, in normal healthy adult participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 119
Inclusion Criteria
- Males or females, between 18 and 65 years of age, inclusive
- BMI range is 20-35 kg/m2, inclusive for the SAD Module, and 25-35 kg/m2, inclusive for the MAD Module at Screening;
- In good health, determined by no clinically significant findings from medical history, physical exam, 12 lead ECG, clinical laboratory findings, and vital signs at Screening and Day -1
Exclusion Criteria
- Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, or psychiatric disorder (as determined by the PI)
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Cohort 7 MAD Placebo NGM282 Dose 1 vs Placebo Cohort 1 SAD NGM282 NGM282 Dose 1 vs Placebo Cohort 1 SAD Placebo NGM282 Dose 1 vs Placebo Cohort 2 SAD NGM282 NGM282 Dose 2 vs Placebo Cohort 2 SAD Placebo NGM282 Dose 2 vs Placebo Cohort 3 SAD NGM282 NGM282 Dose 3 vs Placebo Cohort 3 SAD Placebo NGM282 Dose 3 vs Placebo Cohort 4 SAD NGM282 NGM282 Dose 4 vs Placebo Cohort 4 SAD Placebo NGM282 Dose 4 vs Placebo Cohort 5 SAD NGM282 NGM282 Dose 5 vs Placebo Cohort 5 SAD Placebo NGM282 Dose 5 vs Placebo Cohort 6 SAD NGM282 NGM282 Dose 6 vs Placebo Cohort 6 SAD Placebo NGM282 Dose 6 vs Placebo Cohort 7 MAD NGM282 NGM282 Dose 1 vs Placebo Cohort 8 MAD NGM282 NGM282 Dose 2 vs Placebo Cohort 8 MAD Placebo NGM282 Dose 2 vs Placebo Cohort 9 MAD NGM282 NGM282 Dose 3 vs Placebo Cohort 9 MAD Placebo NGM282 Dose 3 vs Placebo Cohort 10 MAD NGM282 NGM282 Dose 4 vs Placebo Cohort 10 MAD Placebo NGM282 Dose 4 vs Placebo Cohort 11 MAD NGM282 NGM282 Dose 5 vs Placebo Cohort 11 MAD Placebo NGM282 Dose 5 vs Placebo Cohort 12 MAD NGM282 NGM282 Dose 6 vs Placebo Cohort 12 MAD Placebo NGM282 Dose 6 vs Placebo
- Primary Outcome Measures
Name Time Method Safety and tolerability 7 days and 14 days To evaluate the safety and tolerability of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants.
- Secondary Outcome Measures
Name Time Method Pharmacokinetics 7 days and 14 days To evaluate the pharmacokinetics of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants.
Pharmacodynamics 7 days and 14 days To evaluate the pharmacodynamics of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants.
Trial Locations
- Locations (1)
NGM Clinical Study Site
🇦🇺Perth, Western Australia, Australia