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

Primary Purpose

Cachexia

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
NGM120
Placebo
Sponsored by
NGM Biopharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cachexia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nucleus Network Limited

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Part A: NGM120

Part A: Placebo

Part B: NGM120

Part B: Placebo

Arm Description

Single Dose

Single Dose

Multiple Dose

Multiple Dose

Outcomes

Primary Outcome Measures

Part A Arm-Single Dose: Treatment Emergent Adverse events
Percentage of total subjects with Treatment Emergent Adverse event
Part B Arm-Multiple Dose: Treatment Emergent Adverse events
Percentage of total subjects with Treatment Emergent Adverse event

Secondary Outcome Measures

Full Information

First Posted
December 8, 2017
Last Updated
August 19, 2019
Sponsor
NGM Biopharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03392116
Brief Title
Single and Multiple Ascending Dose Study of NGM120 in Healthy Adult Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 29, 2018 (Actual)
Primary Completion Date
January 14, 2019 (Actual)
Study Completion Date
March 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NGM Biopharmaceuticals, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cachexia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A: NGM120
Arm Type
Experimental
Arm Description
Single Dose
Arm Title
Part A: Placebo
Arm Type
Placebo Comparator
Arm Description
Single Dose
Arm Title
Part B: NGM120
Arm Type
Experimental
Arm Description
Multiple Dose
Arm Title
Part B: Placebo
Arm Type
Placebo Comparator
Arm Description
Multiple Dose
Intervention Type
Biological
Intervention Name(s)
NGM120
Intervention Description
Subcutaneous Injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous Injection
Primary Outcome Measure Information:
Title
Part A Arm-Single Dose: Treatment Emergent Adverse events
Description
Percentage of total subjects with Treatment Emergent Adverse event
Time Frame
28 days
Title
Part B Arm-Multiple Dose: Treatment Emergent Adverse events
Description
Percentage of total subjects with Treatment Emergent Adverse event
Time Frame
84 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Nucleus Network Limited
City
Melbourne
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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