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

Sponsor

Goldfinch Bio, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04880291

Collaborator

(none)

Enrollment

Location

Arms

9.2

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Diseases Diabetic Nephropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases	Drug: GFB-024 Drug: Placebo	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 5, 2021

Actual Primary Completion Date :

Feb 8, 2022

Actual Study Completion Date :

Feb 8, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: GFB-024 SAD Active Single ascending dose arm of GFB-024 treatment	Drug: GFB-024 Peripherally acting Cannabinoid-1 receptor inverse agonist monoclonal antibody
Placebo Comparator: SAD Placebo Single ascending dose arm of placebo treatment	Drug: Placebo Matched placebo
Active Comparator: GFB-024 Repeat-dose Active Repeat-dose arm of GFB-024 treatment	Drug: GFB-024 Peripherally acting Cannabinoid-1 receptor inverse agonist monoclonal antibody
Placebo Comparator: Repeat-dose Placebo Repeat-dose arm of placebo treatment	Drug: Placebo Matched placebo

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.