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

Phase 1

Completed

• Conditions: Cachexia
• Interventions: Biological: NGM120; Other: Placebo

• Registration Number: NCT03392116
• Lead Sponsor: NGM Biopharmaceuticals, Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-08
• Study First Submitted QC: 2018-01-04
• Study First Posted: 2018-01-05
• Study Start: 2018-01-29
• Primary Completion: 2019-01-14
• Study Completion: 2019-03-11
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Part A: NGM120	NGM120	Single Dose
Part A: Placebo	Placebo	Single Dose
Part B: NGM120	NGM120	Multiple Dose
Part B: Placebo	Placebo	Multiple Dose

Primary Outcome Measures

Name	Time	Method
Part A Arm-Single Dose: Treatment Emergent Adverse events	28 days	Percentage of total subjects with Treatment Emergent Adverse event
Part B Arm-Multiple Dose: Treatment Emergent Adverse events	84 days	Percentage of total subjects with Treatment Emergent Adverse event

Trial Locations

Locations (1)

Nucleus Network Limited; 🇦🇺 Melbourne, Australia