Diabetes Mellitus
Conditions
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.
Interventions
BIOLOGICALNGM282
BIOLOGICALPlacebo
Sponsors
NGM Biopharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | 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
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics | 7 days and 14 days | To evaluate the pharmacokinetics of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants. |
| Pharmacodynamics | 7 days and 14 days | To evaluate the pharmacodynamics of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants. |
Countries
Australia
Outcome results
None listed