NCT03998514

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: CohBar, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Nonalcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	CB4211 Dose 1	Administered by subcutaneous injection
DRUG	CB4211 Dose 2	Administered by subcutaneous injection
DRUG	CB4211 Dose 3	Administered by subcutaneous injection
DRUG	CB4211 Dose 4	Administered by subcutaneous injection
DRUG	CB4211 Dose 5	Administered by subcutaneous injection
DRUG	CB4211 Dose 6	Administered by subcutaneous injection
DRUG	CB4211 Dose TBD	Administered by subcutaneous injection
DRUG	Placebo	Administered by subcutaneous injection

Timeline

• Start date: 2018-07-09
• Primary completion: 2021-04-19
• Completion: 2021-04-19
• First posted: 2019-06-26
• Last updated: 2021-05-11

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study