Clinical Trials Logo
  1. Home
  2. Cachexia
  3. NCT03392116
  4. Details
NCT03392116 Clinical Trial

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

Cachexia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03392116
Other study ID # 17-0401
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 29, 2018
Est. completion date March 11, 2019

Study information
Verified date August 2019
Source NGM Biopharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 92
Est. completion date March 11, 2019
Est. primary completion date January 14, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• NGM120
Subcutaneous Injection
Other:
• Placebo
Subcutaneous Injection

Locations
Country Name City State
Australia Nucleus Network Limited Melbourne

Sponsors (1)
Lead Sponsor Collaborator
NGM Biopharmaceuticals, Inc

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Part A Arm-Single Dose: Treatment Emergent Adverse events Percentage of total subjects with Treatment Emergent Adverse event 28 days
Primary Part B Arm-Multiple Dose: Treatment Emergent Adverse events Percentage of total subjects with Treatment Emergent Adverse event 84 days
See also
  Status Clinical Trial Phase
Recruiting NCT05603585 - Optimal Protein Supplementation and Early Exercise In Mechanically Ventilated Patients N/A
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients
Enrolling by invitation NCT05028192 - Mitochondria Preservation by Exercise Training: a Targeted Therapy for Cancer and Chemotherapy-induced Cachexia
Completed NCT01696604 - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2849466 in Healthy Male Subjects Phase 1
Recruiting NCT04627376 - Multimodal Program for Cancer Related Cachexia Prevention N/A
Completed NCT02567773 - Safety, Tolerability, Pharmacokinetic (PK), and Pharmacodynamic Study of GSK2881078 and Study to Evaluate the Effect of CYP3A4 Inhibition on PK of GSK2881078 Phase 1
Completed NCT00866970 - Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia Phase 2
Active, not recruiting NCT00710632 - Screening to Predict Weight Loss in Patients With Cancer N/A
Completed NCT00031785 - Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer Phase 3
Withdrawn NCT02017925 - Pulmonary Rehabilitation in Improving Lung Function in Patients With Locally Advanced Non-Small Cell Lung Cancer Undergoing Chemoradiation N/A
Recruiting NCT01829880 - Impact of Body Composition on Bisoprolol and Ramipril Pharmacokinetics in Patients With Chronic Heart Failure N/A
Completed NCT01692990 - Study on the Effect of Fish Oil and Appetite Phase 0
Completed NCT01419145 - A Feasibility Study of Multimodal Exercise/Nutrition/Anti-inflammatory Treatment for Cachexia - the Pre-MENAC Study N/A
Completed NCT00994669 - Development of a Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients N/A
Terminated NCT00962234 - Metabolism of Lipids in Advanced Cancer N/A
Completed NCT01015274 - Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients
Terminated NCT00851448 - Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Lung Cancer Patients N/A
Completed NCT00972634 - Computerized Questionnaires in Assessing Symptoms, Pain, Depression, and Physical Function in Patients With Metastatic and/or Advanced Locoregional Cancer N/A
Terminated NCT00558558 - Haelan and Nutrition in Cancer Patients Phase 2
Terminated NCT00535015 - Safety and Efficacy Study of Betamarc to Treat Loss of Weight and Appetite in Non-Small Cell Lung Cancer Phase 2