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

Phase 1

Completed

• Conditions: Diabetes Mellitus; Kidney Diseases; Diabetes Complications; Diabetic Nephropathies; Endocrine System Diseases
• Interventions: Drug: Placebo; Drug: GFB-024

• Registration Number: NCT04880291
• Lead Sponsor: Goldfinch Bio, Inc.

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 Timeline

• Study Start: 2021-05-05
• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-05
• Study First Posted: 2021-05-10
• Primary Completion: 2022-02-08
• Study Completion: 2022-02-08
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Repeat-dose Placebo	Placebo	Repeat-dose arm of placebo treatment
GFB-024 SAD Active	GFB-024	Single ascending dose arm of GFB-024 treatment
SAD Placebo	Placebo	Single ascending dose arm of placebo treatment
GFB-024 Repeat-dose Active	GFB-024	Repeat-dose arm of GFB-024 treatment

Primary Outcome Measures

Name	Time	Method
Safety and tolerability following single ascending doses of GFB-024	Approximately 10 weeks	Number of participants with serious and other nonserious adverse events

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability following repeated doses over 4 weeks of GFB-024	Approximately 13 weeks	Number of participants with serious and other nonserious adverse events
Characterize PK of GFB-024 following single ascending doses (Cmax)	Approximately 10 weeks	Maximum serum concentration
Characterize PK of GFB-024 following single ascending doses (AUClast)	Approximately 10 weeks	Area under the serum concentration-time curve from time zero to last measurable concentration
Characterize PK of GFB-024 following repeated doses (Cmax)	Approximately 13 weeks	Maximum serum concentration
Characterize PK of GFB-024 following repeated doses (AUClast)	Approximately 13 weeks	Area under the serum concentration-time curve from time zero to last measurable concentration
Characterize the incidence and persistence of immunogenicity of GFB-024 following single ascending doses	Approximately 10 weeks	Number of participants with confirmed antidrug antibodies
Characterize the incidence and persistence of immunogenicity of GFB-024 following repeated doses	Approximately 13 weeks	Number of participants with confirmed antidrug antibodies

Trial Locations

Locations (1)

Worldwide Clinical Trials; 🇺🇸 San Antonio, Texas, United States