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

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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Diseases; Diabetes Mellitus; Endocrine System Diseases; Diabetes Complications; Diabetic Nephropathies
• Intervention / Treatment: Drug: Placebo; Drug: GFB-024

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78217
      • Worldwide Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability following single ascending doses of GFB-024	Number of participants with serious and other nonserious adverse events	Approximately 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Characterize PK of GFB-024 following single ascending doses (Cmax)	Maximum serum concentration	Approximately 10 weeks
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
Characterize PK of GFB-024 following repeated doses (Cmax)	Maximum serum concentration	Approximately 13 weeks
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
Characterize the incidence and persistence of immunogenicity of GFB-024 following single ascending doses	Number of participants with confirmed antidrug antibodies	Approximately 10 weeks
Characterize the incidence and persistence of immunogenicity of GFB-024 following repeated doses	Number of participants with confirmed antidrug antibodies	Approximately 13 weeks

Collaborators and Investigators

• Sponsor: Goldfinch Bio, Inc.
• Investigators: Principal Investigator: Ingela Danielsson, MD, PhD, MBA, Worldwide Clinical Trails

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Actual): February 8, 2022
• Study Completion (Actual): February 8, 2022

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Urologic Diseases; Body Weight; Diabetes Mellitus; Kidney Diseases; Diabetic Nephropathies; Overweight; Endocrine System Diseases; Diabetes Complications
• Other Study ID Numbers: GFB-024-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No