Status:
COMPLETED
First-In-Human Study of GFB-024 in Healthy Overweight and Obese Participants, and Participants With Type 2 Diabetes
Lead Sponsor:
Goldfinch Bio, Inc.
Conditions:
Kidney Diseases
Diabetic Nephropathies
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 safe...
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)...
Eligibility Criteria
Inclusion
- 18 to 75 years of age at the time of signing informed consent.
- Body mass index (BMI) between 25.0 and 40.0 kg/m2, inclusive, at Screening.
- Female participants will be of non-childbearing potential.
- Male participants will agree to use contraception while on study intervention and for at least 6 months after the last dose of study intervention.
- SAD cohorts only: Participants must be in good health.
- Repeat-dose cohort only: Type 2 diabetes mellitus (T2DM) treated with lifestyle modification or metformin, and in otherwise good health except for well-controlled common conditions associated with T2DM, such as hypertension and dyslipidemia.
Exclusion
- History of, or treatment for, psychiatric illness, including anxiety or depression within 5 years of the Screening visit.
- Participants with a history of attempted suicide or clinically significant suicidal ideation.
- History of cardiovascular disease.
- Blood pressure \>155 mmHg systolic or \>95 mmHg diastolic.
- History of alcoholism or drug/chemical abuse within 2 years prior to Screening.
- Alcohol consumption of \>21 units per week for males and \>14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1.5 oz (45 mL) liquor, or 5 oz (150 mL) wine.
- History of significant hypersensitivity, intolerance, or allergy to more than one class of drugs.
- Positive hepatitis panel and/or positive human immunodeficiency virus test. Participants whose results are compatible with prior immunization may be included.
- SAD cohorts only: Fasting glucose \>126 mg/dL.
Key Trial Info
Start Date :
May 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2022
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04880291
Start Date
May 5 2021
End Date
February 8 2022
Last Update
March 28 2022
Active Locations (1)
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1
Worldwide Clinical Trials
San Antonio, Texas, United States, 78217