Phase 1 SAD and MAD Study of NGM282 in Healthy Adult Participants

Phase 1

Completed

• Conditions: Diabetes Mellitus

• 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

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-18
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-28
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-30
• Last Update Posted: 2013-12-31

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

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