A Phase 1a/1b Study of CB4211 in Healthy Non-obese Subjects and Subjects With Nonalcoholic Fatty Liver Disease

Nonalcoholic Fatty Liver Disease Clinical Trial

Official title: A Phase 1a/1b Study of Safety, Tolerability, and Pharmacokinetics of CB4211 in Healthy Non-obese Subjects and Subjects With Nonalcoholic Fatty Liver Disease

Status Completed

Clinical Trial Summary

This is a 3 part, randomized, double blind, placebo controlled study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending subcutaneous (SC) doses of CB4211 in healthy non obese subjects and subjects with NAFLD.

Clinical Trial Description

Part A: Part A is a randomized, double blind, placebo controlled, single ascending dose sequential group study evaluating the safety, tolerability, PK, and PD of a single SC dose of CB4211 in healthy non obese subjects.

Part B: Part B is a randomized, double blind, placebo controlled, multiple ascending dose sequential group study evaluating the safety, tolerability, PK, and PD of once daily SC doses of CB4211 over 7 days in healthy non obese subjects.

Part C: Part C is a randomized, double blind, placebo controlled, multiple dose, parallel group study evaluating the safety, tolerability, PK, and PD of once daily SC doses of CB4211 over 28 days in subjects with NAFLD. ;

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease

• NCT number: NCT03998514
• Study type: Interventional
• Source: CohBar, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: July 9, 2018
• Completion date: April 19, 2021