Diabetes Complications, Diabetes Mellitus, Diabetic Nephropathies, Endocrine System Diseases, Kidney Diseases
Conditions
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.
Interventions
DRUGGFB-024
Peripherally acting Cannabinoid-1 receptor inverse agonist monoclonal antibody
DRUGPlacebo
Matched placebo
Sponsors
Goldfinch Bio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability following single ascending doses of GFB-024 | Approximately 10 weeks | Number of participants with serious and other nonserious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
| 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 |
Countries
United States
Outcome results
None listed