Trials / Completed
CompletedNCT04880291
First-In-Human Study of GFB-024 in Healthy Overweight and Obese Participants, and Participants With Type 2 Diabetes
A First-In-Human, Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GFB-024 as a Single Dose in Healthy Overweight and Obese Participants and as Multiple Doses in Participants With Type 2 Diabetes Mellitus
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Goldfinch Bio, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
GFB-024 is intended for use in patients with kidney disease such as diabetic nephropathy. This study is the first time GFB-024 has been used in humans. The first part of the study will assess the safety of a single dose of GFB-024 in healthy overweight and obese volunteers and the effect of GFB-024 on the body as compared to an inactive placebo medication. The second part of the study will assess the safety of repeated doses of GFB-024 in participants with Type 2 diabetes and the effect of GFB-024 on the body as compared to an inactive placebo medication.
Detailed description
This is a first-in-human study. It is intended to provide the initial safety, pharmacokinetics (PK), and pharmacology data for GFB-024 in humans. This study will comprise a single ascending dose (SAD) escalation component in healthy overweight and obese volunteer participants and a repeat-dose component to confirm repeat-dose safety, tolerability, PK, and immunogenicity in participants with Type 2 diabetes mellitus. It will also explore potential cannabinoid-1 receptor (CB1) activity, participant selection, pharmacodynamics, and differential response biomarkers.
Conditions
- Kidney Diseases
- Diabetic Nephropathies
- Diabetes Complications
- Diabetes Mellitus
- Endocrine System Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GFB-024 | Peripherally acting Cannabinoid-1 receptor inverse agonist monoclonal antibody |
| DRUG | Placebo | Matched placebo |
Timeline
- Start date
- 2021-05-05
- Primary completion
- 2022-02-08
- Completion
- 2022-02-08
- First posted
- 2021-05-10
- Last updated
- 2022-03-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04880291. Inclusion in this directory is not an endorsement.