Healthy Volunteers
Conditions
Keywords
Glomerulosclerosis, proteinuria, nephrotic syndrome, nephrosis, focal segmental glomerulosclerosis, kidney diseases, urologic diseases, glomerulonephritis, nephritis, diabetic kidney disease, diabetic nephropathies, endocrine system diseases, diabetes complications
Brief summary
The study will comprise primarily a single-ascending dose (SAD) escalation component.
Detailed description
Double-blind, randomized, placebo-controlled, single-dose, sequential-group design in up to 7 cohorts of healthy participants.
Interventions
DRUGGFB-887
IMP
DRUGPlacebo
Matching
Sponsors
Goldfinch Bio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Blinded
Intervention model description
Dose escalation, parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy Participant Cohorts - Key Inclusion Criteria: 1. Males or females, of any race, between 18 and 55 years of age, inclusive, at Screening. 2. Body mass index between 18.0 and 32.0 kg/m\^2, inclusive, at Screening. 3. Systolic blood pressure of between 90 and 140 mmHg, diastolic blood pressure between 60 and 90 mmHg, and heart rate between 40 and 100 bpm at Screening. 4. Female participants will be post-menopausal or surgically sterile (as confirmed by medical history). 5. Male participants will agree to use contraception while on study drug and for at least 90 days after the final follow-up visit. 6. Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions. 7. Participants must be in good health. Healthy Participant Cohorts - Key
Exclusion criteria
1. Females of childbearing potential. 2. Significant history or clinically significant manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee). 3. History of alcoholism or drug/chemical abuse within 2 years prior to (first) Check-in. 4. Use of tobacco or nicotine-containing products within 60 days prior to (first) dosing, or positive cotinine at Screening or Check-in.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma PK parameters: Cmax | Approximately 5.5 weeks | PK |
| Plasma PK parameters: Tmax | Approximately 5.5 weeks | PK |
| Incidence and severity of AEs | Approximately 5.5 weeks | Safety and tolerability |
| Incidence of clinically significant changes in laboratory parameters, 12 lead ECG parameters, vital signs measurements, spirometry, and physical examinations | Approximately 5.5 weeks | Safety and tolerability |
| Plasma PK parameters: AUC | Approximately 5.5 weeks | PK |
| Urine PK parameters: Ae | Approximately 5.5 weeks | PK |
| Urine PK parameters: Fe | Approximately 5.5 weeks | PK |
| Urine PK parameters: CLR | Approximately 5.5 weeks | PK |
Countries
United States
Outcome results
None listed