| Trial ID: | L0007 |
| Source ID: | NCT03998514
|
| Associated Drug: |
CB4211
|
| Title: |
A Phase 1a/1b Study of CB4211 in Healthy Non-obese Subjects and Subjects With Nonalcoholic Fatty Liver Disease
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Fatty Liver Disease
|
| Interventions: |
Drug: CB4211 Dose 1|Drug: CB4211 Dose 2|Drug: CB4211 Dose 3|Drug: CB4211 Dose 4|Drug: CB4211 Dose 5|Drug: CB4211 Dose 6|Drug: CB4211 Dose TBD|Drug: Placebo
|
| Outcome Measures: |
Incidence and severity of adverse events (AEs)|Clinical laboratory evaluations|Vital Signs|12-lead ECG parameters|Physical examinations|Injection-site assessments|Area under the blood/plasma concentration time curve from time zero to infinity of CB4211|Area under the blood/plasma concentration time curve from time zero to the time of the last quantifiable concentration of CB4211|Area under the blood/plasma concentration time curve from time zero to 24 hours postdose of CB4211|Maximum observed blood/plasma concentration of CB4211|Time of the maximum observed blood/plasma concentration of CB4211|Apparent blood/plasma terminal elimination half life of CB4211|Apparent total blood/plasma clearance of CB4211|Apparent volume of distribution of CB4211|Amount of CB4211 excreted in urine over the sampling interval|Percentage of CB4211 excreted in urine|Renal clearance of CB4211|Incidence of antidrug antibodies (ADAs)
|
| Sponsor/Collaborators: |
CohBar, Inc.
|
| Gender: |
All
|
| Age: |
18 Years to 60 Years ?? (Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
88
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
|
| Start Date: |
July 9, 2018
|
| Completion Date: |
April 19, 2021
|
| Results First Posted: |
--
|
| Last Update Posted: |
May 11, 2021
|
| Locations: |
ProScietno, Chula Vista, California, United States|Covance Clinical Research Unit Inc., Dallas, Texas, United States|The Texas Liver Institute, San Antonio, Texas, United States|Endeavor Clinical Trials, LLC, San Antonio, Texas, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT03998514
|
