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

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Biological: Placebo; Biological: NGM282

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Western Australia
    • Perth, Western Australia, Australia, 6009
      • NGM Clinical Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 SAD; NGM282 Dose 1 vs Placebo	Biological: Placebo; Biological: NGM282
Experimental: Cohort 2 SAD; NGM282 Dose 2 vs Placebo	Biological: Placebo; Biological: NGM282
Experimental: Cohort 3 SAD; NGM282 Dose 3 vs Placebo	Biological: Placebo; Biological: NGM282
Experimental: Cohort 4 SAD; NGM282 Dose 4 vs Placebo	Biological: Placebo; Biological: NGM282
Experimental: Cohort 5 SAD; NGM282 Dose 5 vs Placebo	Biological: Placebo; Biological: NGM282
Experimental: Cohort 6 SAD; NGM282 Dose 6 vs Placebo	Biological: Placebo; Biological: NGM282
Experimental: Cohort 7 MAD; NGM282 Dose 1 vs Placebo	Biological: Placebo; Biological: NGM282
Experimental: Cohort 8 MAD; NGM282 Dose 2 vs Placebo	Biological: Placebo; Biological: NGM282
Experimental: Cohort 9 MAD; NGM282 Dose 3 vs Placebo	Biological: Placebo; Biological: NGM282
Experimental: Cohort 10 MAD; NGM282 Dose 4 vs Placebo	Biological: Placebo; Biological: NGM282
Experimental: Cohort 11 MAD; NGM282 Dose 5 vs Placebo	Biological: Placebo; Biological: NGM282
Experimental: Cohort 12 MAD; NGM282 Dose 6 vs Placebo	Biological: Placebo; Biological: NGM282

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability	To evaluate the safety and tolerability of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants.	7 days and 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics	To evaluate the pharmacokinetics of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants.	7 days and 14 days
Pharmacodynamics	To evaluate the pharmacodynamics of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants.	7 days and 14 days

Collaborators and Investigators

• Sponsor: NGM Biopharmaceuticals, Inc
• Investigators: Study Director: Alex M DePaoli, MD, NGM Biopharmaceuticals, Inc

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: January 18, 2013
• First Submitted That Met QC Criteria: January 23, 2013
• First Posted (Estimate): January 28, 2013

Study Record Updates

• Last Update Posted (Estimate): December 31, 2013
• Last Update Submitted That Met QC Criteria: December 30, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 12-0101