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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01776528
Recruitment Status : Completed
First Posted : January 28, 2013
Last Update Posted : December 31, 2013
Sponsor:
Information provided by (Responsible Party):
NGM Biopharmaceuticals, Inc

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Biological: NGM282 Biological: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, 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
Study Start Date : January 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 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 :
  1. Pharmacokinetics [ Time Frame: 7 days and 14 days ]
    To evaluate the pharmacokinetics of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants.

  2. Pharmacodynamics [ Time Frame: 7 days and 14 days ]
    To evaluate the pharmacodynamics of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01776528


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

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Responsible Party: NGM Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01776528    
Other Study ID Numbers: 12-0101
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: December 31, 2013
Last Verified: December 2013