Single and Multiple Ascending Dose Study of NGM120 in Healthy Adult Subjects
Phase 1
Completed
- Conditions
- Cachexia
- Registration Number
- NCT03392116
- Lead Sponsor
- NGM Biopharmaceuticals, Inc
- Brief Summary
The purpose is to evaluate the safety, tolerability, and PK of NGM120 in healthy adult subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Part A Arm-Single Dose: Treatment Emergent Adverse events 28 days Percentage of total subjects with Treatment Emergent Adverse event
Part B Arm-Multiple Dose: Treatment Emergent Adverse events 84 days Percentage of total subjects with Treatment Emergent Adverse event
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does NGM120 target to address cachexia-related metabolic dysregulation?
How does NGM120's pharmacokinetic profile compare to standard-of-care cachexia treatments like anamorelin?
Which biomarkers correlate with NGM120 efficacy in cachexia models or clinical trials?
What adverse events were observed in NCT03392116 and how do they align with NGM Biopharmaceuticals' safety protocols?
Are there combination therapies involving NGM120 and other cachexia-targeting agents (e.g., ghrelin agonists) under investigation?
Trial Locations
- Locations (1)
Nucleus Network Limited
🇦🇺Melbourne, Australia
Nucleus Network Limited🇦🇺Melbourne, Australia