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

NGM Biopharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus

Treatments: Biological: NGM282; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01776528

12-0101

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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119 participants in 12 patient groups

Cohort 1 SAD

Experimental group

Description:

NGM282 Dose 1 vs Placebo

Treatment:

Biological: Placebo

Biological: NGM282

Cohort 2 SAD

Experimental group

Description:

NGM282 Dose 2 vs Placebo

Treatment:

Biological: Placebo

Biological: NGM282

Cohort 3 SAD

Experimental group

Description:

NGM282 Dose 3 vs Placebo

Treatment:

Biological: Placebo

Biological: NGM282

Cohort 4 SAD

Experimental group

Description:

NGM282 Dose 4 vs Placebo

Treatment:

Biological: Placebo

Biological: NGM282

Cohort 5 SAD

Experimental group

Description:

NGM282 Dose 5 vs Placebo

Treatment:

Biological: Placebo

Biological: NGM282

Cohort 6 SAD

Experimental group

Description:

NGM282 Dose 6 vs Placebo

Treatment:

Biological: Placebo

Biological: NGM282

Cohort 7 MAD

Experimental group

Description:

NGM282 Dose 1 vs Placebo

Treatment:

Biological: Placebo

Biological: NGM282

Cohort 8 MAD

Experimental group

Description:

NGM282 Dose 2 vs Placebo

Treatment:

Biological: Placebo

Biological: NGM282

Cohort 9 MAD

Experimental group

Description:

NGM282 Dose 3 vs Placebo

Treatment:

Biological: Placebo

Biological: NGM282

Cohort 10 MAD

Experimental group

Description:

NGM282 Dose 4 vs Placebo

Treatment:

Biological: Placebo

Biological: NGM282

Cohort 11 MAD

Experimental group

Description:

NGM282 Dose 5 vs Placebo

Treatment:

Biological: Placebo

Biological: NGM282

Cohort 12 MAD

Experimental group

Description:

NGM282 Dose 6 vs Placebo

Treatment:

Biological: Placebo

Biological: NGM282