Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NGM Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01776528
First received: January 18, 2013
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Biological: NGM282
Biological: Placebo
Phase 1

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

Further study details as provided by NGM Biopharmaceuticals, Inc:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 7 days and 14 days ] [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants.


Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 7 days and 14 days ] [ Designated as safety issue: No ]
    To evaluate the pharmacokinetics of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants.

  • Pharmacodynamics [ Time Frame: 7 days and 14 days ] [ Designated as safety issue: No ]
    To evaluate the pharmacodynamics of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants.


Enrollment: 119
Study Start Date: January 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 SAD
NGM282 Dose 1 vs Placebo
Biological: NGM282 Biological: Placebo
Experimental: Cohort 2 SAD
NGM282 Dose 2 vs Placebo
Biological: NGM282 Biological: Placebo
Experimental: Cohort 3 SAD
NGM282 Dose 3 vs Placebo
Biological: NGM282 Biological: Placebo
Experimental: Cohort 4 SAD
NGM282 Dose 4 vs Placebo
Biological: NGM282 Biological: Placebo
Experimental: Cohort 5 SAD
NGM282 Dose 5 vs Placebo
Biological: NGM282 Biological: Placebo
Experimental: Cohort 6 SAD
NGM282 Dose 6 vs Placebo
Biological: NGM282 Biological: Placebo
Experimental: Cohort 7 MAD
NGM282 Dose 1 vs Placebo
Biological: NGM282 Biological: Placebo
Experimental: Cohort 8 MAD
NGM282 Dose 2 vs Placebo
Biological: NGM282 Biological: Placebo
Experimental: Cohort 9 MAD
NGM282 Dose 3 vs Placebo
Biological: NGM282 Biological: Placebo
Experimental: Cohort 10 MAD
NGM282 Dose 4 vs Placebo
Biological: NGM282 Biological: Placebo
Experimental: Cohort 11 MAD
NGM282 Dose 5 vs Placebo
Biological: NGM282 Biological: Placebo
Experimental: Cohort 12 MAD
NGM282 Dose 6 vs Placebo
Biological: NGM282 Biological: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776528

Locations
Australia, Western Australia
NGM Clinical Study Site
Perth, Western Australia, Australia, 6009
Sponsors and Collaborators
NGM Biopharmaceuticals, Inc
Investigators
Study Director: Alex M DePaoli, MD NGM Biopharmaceuticals, Inc
  More Information

Additional Information:
No publications provided

Responsible Party: NGM Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01776528     History of Changes
Other Study ID Numbers: 12-0101
Study First Received: January 18, 2013
Last Updated: December 30, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014