First-In-Human Study of GFB-024 in Healthy Overweight and Obese Participants, and Participants With Type 2 Diabetes

• Status: Recruiting
• Trial end date: 2021-11-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Goldfinch Bio, Inc.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.