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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Biological: NGM282
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 SAD<br>NGM282 Dose 1 vs Placebo | Biological: NGM282<br> <br> Biological: Placebo<br> <br> |
| Experimental: Cohort 2 SAD<br>NGM282 Dose 2 vs Placebo | Biological: NGM282<br> <br> Biological: Placebo<br> <br> |
| Experimental: Cohort 3 SAD<br>NGM282 Dose 3 vs Placebo | Biological: NGM282<br> <br> Biological: Placebo<br> <br> |
| Experimental: Cohort 4 SAD<br>NGM282 Dose 4 vs Placebo | Biological: NGM282<br> <br> Biological: Placebo<br> <br> |
| Experimental: Cohort 5 SAD<br>NGM282 Dose 5 vs Placebo | Biological: NGM282<br> <br> Biological: Placebo<br> <br> |
| Experimental: Cohort 6 SAD<br>NGM282 Dose 6 vs Placebo | Biological: NGM282<br> <br> Biological: Placebo<br> <br> |
| Experimental: Cohort 7 MAD<br>NGM282 Dose 1 vs Placebo | Biological: NGM282<br> <br> Biological: Placebo<br> <br> |
| Experimental: Cohort 8 MAD<br>NGM282 Dose 2 vs Placebo | Biological: NGM282<br> <br> Biological: Placebo<br> <br> |
| Experimental: Cohort 9 MAD<br>NGM282 Dose 3 vs Placebo | Biological: NGM282<br> <br> Biological: Placebo<br> <br> |
| Experimental: Cohort 10 MAD<br>NGM282 Dose 4 vs Placebo | Biological: NGM282<br> <br> Biological: Placebo<br> <br> |
| Experimental: Cohort 11 MAD<br>NGM282 Dose 5 vs Placebo | Biological: NGM282<br> <br> Biological: Placebo<br> <br> |
| Experimental: Cohort 12 MAD<br>NGM282 Dose 6 vs Placebo | Biological: NGM282<br> <br> Biological: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | To evaluate the safety and tolerability of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants. | 7 days and 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | To evaluate the pharmacokinetics of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants. | 7 days and 14 days | 
| Pharmacodynamics | To evaluate the pharmacodynamics of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants. | 7 days and 14 days |