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NCT03392116 Clinical Trial

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

Cachexia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03392116
Other study ID # 17-0401
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 29, 2018
Est. completion date March 11, 2019

Study information
Verified date August 2019
Source NGM Biopharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 92
Est. completion date March 11, 2019
Est. primary completion date January 14, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• NGM120
Subcutaneous Injection
Other:
• Placebo
Subcutaneous Injection

Locations
Country Name City State
Australia Nucleus Network Limited Melbourne

Sponsors (1)
Lead Sponsor Collaborator
NGM Biopharmaceuticals, Inc

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Part A Arm-Single Dose: Treatment Emergent Adverse events Percentage of total subjects with Treatment Emergent Adverse event 28 days
Primary Part B Arm-Multiple Dose: Treatment Emergent Adverse events Percentage of total subjects with Treatment Emergent Adverse event 84 days
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