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

August 19, 2019 updated by: NGM Biopharmaceuticals, Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia
        • Nucleus Network Limited

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NGM Biopharmaceuticals, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2018

Primary Completion (Actual)

January 14, 2019

Study Completion (Actual)

March 11, 2019

Study Registration Dates

First Submitted

December 8, 2017

First Submitted That Met QC Criteria

January 4, 2018

First Posted (Actual)

January 5, 2018

Study Record Updates

Last Update Posted (Actual)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-0401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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