Single and Multiple Ascending Dose Study of NGM120 in Healthy Adult Subjects
Sponsor
NGM Biopharmaceuticals, Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT03392116
Collaborator
(none)
92
1
4
13.3
6.9
Study Details
Study Description
Brief Summary
The purpose is to evaluate the safety, tolerability, and PK of NGM120 in healthy adult subjects
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
92 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Jan 29, 2018
Actual Primary Completion Date
:
Jan 14, 2019
Actual Study Completion Date
:
Mar 11, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part A: NGM120 Single Dose |
Biological: NGM120
Subcutaneous Injection
|
| Placebo Comparator: Part A: Placebo Single Dose |
Other: Placebo
Subcutaneous Injection
|
| Experimental: Part B: NGM120 Multiple Dose |
Biological: NGM120
Subcutaneous Injection
|
| Placebo Comparator: Part B: Placebo Multiple Dose |
Other: Placebo
Subcutaneous Injection
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nucleus Network Limited | Melbourne | Australia |
Sponsors and Collaborators
- NGM Biopharmaceuticals, Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
NGM Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT03392116
Other Study ID Numbers:
- 17-0401
First Posted:
Jan 5, 2018
Last Update Posted:
Aug 20, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: