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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01776528
• Other study ID #: 12-0101
• Status: Completed
• Phase: Phase 1
• First received: January 18, 2013
• Last updated: December 30, 2013
• Start date: January 2013
• Est. completion date: July 2013

Study information

• Verified date: December 2013
• Source: NGM Biopharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Biological:
• NGM282

• Placebo

Locations

Country	Name	City	State
Australia	NGM Clinical Study Site	Perth	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
NGM Biopharmaceuticals, Inc

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Pharmacokinetics	To evaluate the pharmacokinetics of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants.	7 days and 14 days	No
Secondary	Pharmacodynamics	To evaluate the pharmacodynamics of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants.	7 days and 14 days	No

External Links

•   Link