Phase 1 SAD and MAD Study of NGM282 in Healthy Adult Participants
This study has been completed.
Sponsor:
NGM Biopharmaceuticals, Inc
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
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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 (Adult) |
| 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
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:
| 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 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on September 26, 2016