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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus | Biological: NGM282 Biological: Placebo | Phase 1 |
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 |
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 |
- 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.
- 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.
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
Australia, Western Australia | |
NGM Clinical Study Site | |
Perth, Western Australia, Australia, 6009 |
Study Director: | Alex M DePaoli, MD | NGM Biopharmaceuticals, Inc |
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 |