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OpenTrials
Completed

NCT Number: NCT03392116

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

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

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Key information

Conditions

Cachexia Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network Limited

Melbourne, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NGM120

Biological

Subcutaneous Injection

Placebo

Other

Subcutaneous Injection

Primary outcomes

  1. Part A Arm-Single Dose: Treatment Emergent Adverse events

    Time frame: 28 days

    Percentage of total subjects with Treatment Emergent Adverse event

  2. Part B Arm-Multiple Dose: Treatment Emergent Adverse events

    Time frame: 84 days

    Percentage of total subjects with Treatment Emergent Adverse event

Sponsors and collaborators

Lead sponsor

NGM Biopharmaceuticals, Inc

Industry

Registry information

Official study title

A Phase 1 Randomized, Double Blind, Placebo Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NGM120 in Healthy Adult Subjects

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 5, 2018
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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