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, Inc1 site in 1 country119 target enrollmentJanuary 2013

ConditionsDiabetes Mellitus

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Diabetes Mellitus
Sponsor: NGM Biopharmaceuticals, Inc
Enrollment: 119
Locations: 1
Primary Endpoint: Safety and tolerability
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

July 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

NGM Biopharmaceuticals, Inc

Responsible Party

Sponsor

Eligibility Criteria

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