NCT01776528CompletedPhase 1
A Phase 1 Randomized, Double Blind, Placebo Controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NGM282 in Healthy Adult Participants
NGM Biopharmaceuticals, Inc2 sites in 1 country119 target enrollmentStarted: January 1, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 119
- Locations
- 2
- Primary Endpoint
- Safety and tolerability
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Safety and tolerability
Time Frame: 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 Outcomes
- Pharmacokinetics(7 days and 14 days)
- Pharmacodynamics(7 days and 14 days)
Investigators
Study Sites (2)
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