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CompletedNCT03392116Updated Aug 20, 2019

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

A Phase 1 interventional study of NGM120 and Placebo in Cachexia, sponsored by NGM Biopharmaceuticals, Inc. Completed at 1 site in Australia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-20.

Sponsored by NGM Biopharmaceuticals, Inc · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Cachexia

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03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Normal ECG findings

Exclusion criteria

Exclusion Criteria:

  • Significant history or clinical manifestation of any allergic, dermatological, hepatic, renal, hematological, pulmonary, metabolic, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Investigator)
Enrollment
92 participants (actual)

Study arms

  • Experimental
    Part A: NGM120

    Single Dose

    Biological: NGM120

  • Placebo comparator
    Part A: Placebo

    Single Dose

    Other: Placebo

  • Experimental
    Part B: NGM120

    Multiple Dose

    Biological: NGM120

  • Placebo comparator
    Part B: Placebo

    Multiple Dose

    Other: Placebo

Interventions

  • BiologicalNGM120

    Subcutaneous Injection

  • OtherPlacebo

    Subcutaneous Injection

05

What researchers measure

Primary outcomes

  1. Part A Arm-Single Dose: Treatment Emergent Adverse events

    Percentage of total subjects with Treatment Emergent Adverse event

    Time frame: 28 days

  2. Part B Arm-Multiple Dose: Treatment Emergent Adverse events

    Percentage of total subjects with Treatment Emergent Adverse event

    Time frame: 84 days

06

Study locations

1 site
  • Nucleus Network Limited
    Melbourne, Australia
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03392116
Lead sponsor
NGM Biopharmaceuticals, Inc
Responsible party
Sponsor
First posted
Jan 5, 2018
Start date
Jan 29, 2018
Primary completion
Jan 14, 2019
Completion
Mar 11, 2019
Last update
Aug 20, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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