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

NCT ID: NCT01776528

Last Updated: 2013-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-07-31

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.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1 SAD

NGM282 Dose 1 vs Placebo

Group Type EXPERIMENTAL

NGM282

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Cohort 2 SAD

NGM282 Dose 2 vs Placebo

Group Type EXPERIMENTAL

NGM282

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Cohort 3 SAD

NGM282 Dose 3 vs Placebo

Group Type EXPERIMENTAL

NGM282

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Cohort 4 SAD

NGM282 Dose 4 vs Placebo

Group Type EXPERIMENTAL

NGM282

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Cohort 5 SAD

NGM282 Dose 5 vs Placebo

Group Type EXPERIMENTAL

NGM282

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Cohort 6 SAD

NGM282 Dose 6 vs Placebo

Group Type EXPERIMENTAL

NGM282

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Cohort 7 MAD

NGM282 Dose 1 vs Placebo

Group Type EXPERIMENTAL

NGM282

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Cohort 8 MAD

NGM282 Dose 2 vs Placebo

Group Type EXPERIMENTAL

NGM282

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Cohort 9 MAD

NGM282 Dose 3 vs Placebo

Group Type EXPERIMENTAL

NGM282

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Cohort 10 MAD

NGM282 Dose 4 vs Placebo

Group Type EXPERIMENTAL

NGM282

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Cohort 11 MAD

NGM282 Dose 5 vs Placebo

Group Type EXPERIMENTAL

NGM282

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Cohort 12 MAD

NGM282 Dose 6 vs Placebo

Group Type EXPERIMENTAL

NGM282

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Interventions

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NGM282

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NGM Biopharmaceuticals, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alex M DePaoli, MD

Role: STUDY_DIRECTOR

NGM Biopharmaceuticals, Inc

Locations

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NGM Clinical Study Site

Perth, Western Australia, Australia

Site Status

Countries

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Australia

Related Links

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http://ngmbio.com/

Related Info

Other Identifiers

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12-0101

Identifier Type: -

Identifier Source: org_study_id