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

NCT03998514 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2021-05-11

No results posted yet for this study

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.

Conditions

  • Nonalcoholic Fatty Liver Disease

Interventions

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

Sponsors & Collaborators

  • CohBar, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-09
Primary Completion
2021-04-19
Completion
2021-04-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03998514 on ClinicalTrials.gov