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

N

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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