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

NCT04880291 | Completed Phase 1 FDA Drug

• 1 other identifier: GFB-024-102
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Diseases; Diabetic Nephropathies; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability following single ascending doses of GFB-024

  Number of participants with serious and other nonserious adverse events

  Approximately 10 weeks

Secondary Outcomes (7)

• Safety and tolerability following repeated doses over 4 weeks of GFB-024

  Approximately 13 weeks

• Characterize PK of GFB-024 following single ascending doses (Cmax)

  Approximately 10 weeks

• Characterize PK of GFB-024 following single ascending doses (AUClast)

  Approximately 10 weeks

• Characterize PK of GFB-024 following repeated doses (Cmax)

  Approximately 13 weeks

• Characterize PK of GFB-024 following repeated doses (AUClast)

  Approximately 13 weeks

Study Arms (4)

GFB-024 SAD Active

ACTIVE COMPARATOR

Single ascending dose arm of GFB-024 treatment

Drug: GFB-024

SAD Placebo

PLACEBO COMPARATOR

Single ascending dose arm of placebo treatment

Drug: Placebo

GFB-024 Repeat-dose Active

ACTIVE COMPARATOR

Repeat-dose arm of GFB-024 treatment

Drug: GFB-024

Repeat-dose Placebo

PLACEBO COMPARATOR

Repeat-dose arm of placebo treatment

Drug: Placebo

Interventions

GFB-024 DRUG

Peripherally acting Cannabinoid-1 receptor inverse agonist monoclonal antibody

GFB-024 Repeat-dose Active; GFB-024 SAD Active

Placebo DRUG

Matched placebo

Repeat-dose Placebo; SAD Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Goldfinch Bio, Inc.: lead

Study Sites (1)

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Conditions

Kidney Diseases; Diabetic Nephropathies; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ingela Danielsson, MD, PhD, MBA

  Worldwide Clinical Trails

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 10, 2021
• Study Start: May 5, 2021
• Primary Completion: February 8, 2022
• Study Completion: February 8, 2022
• Last Updated: March 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)