| Trial ID: | L5922 |
| Source ID: | NCT04880291
|
| Associated Drug: |
Gfb-024
|
| Title: |
First-In-Human Study of GFB-024 in Healthy Overweight and Obese Participants, and Participants With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Kidney Diseases|Diabetic Nephropathies|Diabetes Complications|Diabetes Mellitus|Endocrine System Diseases
|
| Interventions: |
DRUG: GFB-024|DRUG: Placebo
|
| Outcome Measures: |
Primary: Safety and tolerability following single ascending doses of GFB-024, Number of participants with serious and other nonserious adverse events, Approximately 10 weeks | Secondary: Safety and tolerability following repeated doses over 4 weeks of GFB-024, Number of participants with serious and other nonserious adverse events, Approximately 13 weeks|Characterize PK of GFB-024 following single ascending doses (Cmax), Maximum serum concentration, Approximately 10 weeks|Characterize PK of GFB-024 following single ascending doses (AUClast), Area under the serum concentration-time curve from time zero to last measurable concentration, Approximately 10 weeks|Characterize PK of GFB-024 following repeated doses (Cmax), Maximum serum concentration, Approximately 13 weeks|Characterize PK of GFB-024 following repeated doses (AUClast), Area under the serum concentration-time curve from time zero to last measurable concentration, Approximately 13 weeks|Characterize the incidence and persistence of immunogenicity of GFB-024 following single ascending doses, Number of participants with confirmed antidrug antibodies, Approximately 10 weeks|Characterize the incidence and persistence of immunogenicity of GFB-024 following repeated doses, Number of participants with confirmed antidrug antibodies, Approximately 13 weeks
|
| Sponsor/Collaborators: |
Sponsor: Goldfinch Bio, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
39
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-05-05
|
| Completion Date: |
2022-02-08
|
| Results First Posted: |
|
| Last Update Posted: |
2022-03-28
|
| Locations: |
Worldwide Clinical Trials, San Antonio, Texas, 78217, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04880291
|
