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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04880291
• Other study ID #: GFB-024-102
• Status: Completed
• Phase: Phase 1
• Start date: May 5, 2021
• Est. completion date: February 8, 2022

Study information

• Verified date: March 2022
• Source: Goldfinch Bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 8, 2022
• Est. primary completion date: February 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus
• Diabetic Nephropathies
• Endocrine System Diseases
• Kidney Diseases
• Overweight

Intervention

Drug:
• GFB-024
Peripherally acting Cannabinoid-1 receptor inverse agonist monoclonal antibody
• Placebo
Matched placebo

Locations

Country	Name	City	State
United States	Worldwide Clinical Trials	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Goldfinch Bio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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