Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 8391348 | Other Identifier | Covance |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will comprise primarily a single-ascending dose (SAD) escalation component.
Double-blind, randomized, placebo-controlled, single-dose, sequential-group design in up to 7 cohorts of healthy participants.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GFB-887 SAD active | Experimental | GFB-887 single dose active |
|
| GFB-887 SAD placebo | Placebo Comparator | GFB-887 single dose placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GFB-887 | Drug | IMP |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of AEs | Safety and tolerability | Approximately 5.5 weeks |
| Incidence of clinically significant changes in laboratory parameters, 12 lead ECG parameters, vital signs measurements, spirometry, and physical examinations | Safety and tolerability | Approximately 5.5 weeks |
| Plasma PK parameters: Cmax | PK | Approximately 5.5 weeks |
| Plasma PK parameters: Tmax | PK | Approximately 5.5 weeks |
| Plasma PK parameters: AUC | PK | Approximately 5.5 weeks |
| Urine PK parameters: Ae | PK | Approximately 5.5 weeks |
| Urine PK parameters: Fe | PK | Approximately 5.5 weeks |
| Urine PK parameters: CLR | PK | Approximately 5.5 weeks |
Not provided
Not provided
Healthy Participant Cohorts - Key Inclusion Criteria:
Healthy Participant Cohorts - Key Exclusion Criteria:
Males, females of non-childbearing potential
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeanelle Kam, MD | Covance Clinical Research Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Inc. | Dallas | Texas | 75247 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011507 | Proteinuria |
| D009404 | Nephrotic Syndrome |
| D009401 | Nephrosis |
| D005923 | Glomerulosclerosis, Focal Segmental |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D003928 | Diabetic Nephropathies |
| D004700 | Endocrine System Diseases |
| D048909 | Diabetes Complications |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Dose escalation, parallel assignment
Not provided
Not provided
Blinded
| Drug |
Matching |
|
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |