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NCT Number: NCT04880291

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

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.

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Key information

Conditions

Kidney Diseases Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GFB-024

Drug

Peripherally acting Cannabinoid-1 receptor inverse agonist monoclonal antibody

Placebo

Drug

Matched placebo

Primary outcomes

  1. Safety and tolerability following single ascending doses of GFB-024

    Time frame: Approximately 10 weeks

    Number of participants with serious and other nonserious adverse events

Secondary outcomes

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

    Time frame: Approximately 13 weeks

    Number of participants with serious and other nonserious adverse events

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

    Time frame: Approximately 10 weeks

    Maximum serum concentration

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

    Time frame: Approximately 10 weeks

    Area under the serum concentration-time curve from time zero to last measurable concentration

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

    Time frame: Approximately 13 weeks

    Maximum serum concentration

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

    Time frame: Approximately 13 weeks

    Area under the serum concentration-time curve from time zero to last measurable concentration

  6. Characterize the incidence and persistence of immunogenicity of GFB-024 following single ascending doses

    Time frame: Approximately 10 weeks

    Number of participants with confirmed antidrug antibodies

  7. Characterize the incidence and persistence of immunogenicity of GFB-024 following repeated doses

    Time frame: Approximately 13 weeks

    Number of participants with confirmed antidrug antibodies

Sponsors and collaborators

Lead sponsor

Goldfinch Bio, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 10, 2021
Registry last updated
Mar 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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