Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04880291
Status:
COMPLETED
Last Update Posted:
2022-03-28
First Post:
2021-05-05
Brief Title:
First-In-Human Study of GFB-024 in Healthy Overweight and Obese Participants and Participants With Type 2 Diabetes
Sponsor:
Goldfinch Bio Inc
Organization:
Goldfinch Bio Inc
Study Overview
Official Title:
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
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None