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

NGM Biopharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Cachexia

Treatments: Other: Placebo; Biological: NGM120

Study type: Interventional

Funder types: Industry

Identifiers

NCT03392116

17-0401

Details and patient eligibility

About

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

Enrollment: 92 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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92 participants in 4 patient groups, including a placebo group

Part A: NGM120

Experimental group

Description:

Single Dose

Treatment:

Biological: NGM120

Part A: Placebo

Placebo Comparator group

Description:

Single Dose

Treatment:

Other: Placebo

Part B: NGM120

Experimental group

Description:

Multiple Dose

Treatment:

Biological: NGM120

Part B: Placebo

Placebo Comparator group

Description:

Multiple Dose

Treatment:

Other: Placebo