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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03392116
Enrollment
92
Registered
2018-01-05
Start date
2018-01-29
Completion date
2019-03-11
Last updated
2019-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cachexia

Brief summary

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

Interventions

BIOLOGICALNGM120

Subcutaneous Injection

OTHERPlacebo

Subcutaneous Injection

Sponsors

NGM Biopharmaceuticals, Inc
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Part A Arm-Single Dose: Treatment Emergent Adverse events28 daysPercentage of total subjects with Treatment Emergent Adverse event
Part B Arm-Multiple Dose: Treatment Emergent Adverse events84 daysPercentage of total subjects with Treatment Emergent Adverse event

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026