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Single and Multiple Ascending Dose Study of NGM120 in Healthy Adult Subjects

NCT ID: NCT03392116

Last Updated: 2019-08-20

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

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-29

Study Completion Date

2019-03-11

Brief Summary

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The purpose is to evaluate the safety, tolerability, and PK of NGM120 in healthy adult subjects

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Detailed Description

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Conditions

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Cachexia

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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Part A: NGM120

Single Dose

Group Type EXPERIMENTAL

NGM120

Intervention Type BIOLOGICAL

Subcutaneous Injection

Part A: Placebo

Single Dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Subcutaneous Injection

Part B: NGM120

Multiple Dose

Group Type EXPERIMENTAL

NGM120

Intervention Type BIOLOGICAL

Subcutaneous Injection

Part B: Placebo

Multiple Dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Subcutaneous Injection

Interventions

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NGM120

Subcutaneous Injection

Intervention Type BIOLOGICAL

Placebo

Subcutaneous Injection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Normal ECG findings

Exclusion Criteria

* Significant history or clinical manifestation of any allergic, dermatological, hepatic, renal, hematological, pulmonary, metabolic, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
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

Locations

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Nucleus Network Limited

Melbourne, , Australia

Site Status

Countries

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Australia

Other Identifiers

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17-0401

Identifier Type: -

Identifier Source: org_study_id

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