Clinical trial NCT04880291: First-In-Human Study of GFB-024 in Healthy Overweight and Obese Participants, and Participants With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Kidney Diseases
Diabetic Nephropathies
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Lead sponsor: Goldfinch Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-10
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety and tolerability following single ascending doses of GFB-024
timeFrame: Approximately 10 weeks
Secondary outcomes:
measure: Safety and tolerability following repeated doses over 4 weeks of GFB-024
timeFrame: Approximately 13 weeks
measure: Characterize PK of GFB-024 following single ascending doses (Cmax)
timeFrame: Approximately 10 weeks
measure: Characterize PK of GFB-024 following single ascending doses (AUClast)
timeFrame: Approximately 10 weeks
measure: Characterize PK of GFB-024 following repeated doses (Cmax)
timeFrame: Approximately 13 weeks
measure: Characterize PK of GFB-024 following repeated doses (AUClast)
timeFrame: Approximately 13 weeks
measure: Characterize the incidence and persistence of immunogenicity of GFB-024 following single ascending doses
timeFrame: Approximately 10 weeks
measure: Characterize the incidence and persistence of immunogenicity of GFB-024 following repeated doses
timeFrame: Approximately 13 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Worldwide Clinical Trials
state: Texas
Study officials:
affiliation: Worldwide Clinical Trails
name: Ingela Danielsson, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: