Title
Phase 1 SAD and MAD Study of NGM282 in Healthy Adult Participants
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
Phase
Phase 1Lead Sponsor
NGM Biopharmaceuticals, IncStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Diabetes MellitusIntervention/Treatment
aldafermin ...Study Participants
119The purpose of this study is to determine the safety and tolerability of NGM282, both single dose and multiple doses, in normal healthy adult participants.
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
