Healthy Volunteer Study
Conditions
Brief summary
This is a Phase I, first-in-human, single-center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and PK of ascending doses of CBP-4888.
Detailed description
This study will involve female subjects meeting all inclusion criteria and no exclusion criteria. Cohorts of CBP-4888 are planned to be investigated in a sequential dose-escalation manner. Each cohort of subjects will be randomized to CBP-4888 to placebo and administered a single subcutaneous dose.
Interventions
DRUGCBP-4888
siRNA therapeutic
OTHERPlacebo
Normal Saline
Sponsors
Comanche Biopharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy non-pregnant female subjects * Body mass index (BMI) ≥ 18.5 and ≤ 35.0 kg/m2 * Medically healthy, defined as having no clinically significant abnormal screening results including clinical laboratory evaluations, medical history, vital signs, ECG, and physical examination as deemed by the Investigator.
Exclusion criteria
* Screening blood pressure \< 100/60 mmHg or \> 140/90 mmHg * Screening heart rate that is \< 40 bpm or \> 99 bpm * Clinically significant ECG abnormality at screening * Used prescription medication within 14 days prior to dosing * Used over the counter (OTC) medications (including herbal products, nutritional supplements, dietary supplements, and/or vitamins) within 7 days prior to dosing * Donated blood or had significant blood loss within 56 days prior to dosing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Swelling at Site of Injection | 30 Days | Assessment of Swelling on a 5 point scale (none, mild, moderate, severe or potentially life threatening) |
| Adverse Events | 30 days | Number of participants with treatment-related adverse events |
| Pain at Site of Injection | 30 days | Assessment of Pain on a 5 point scale (none, mild, moderate, severe or potentially life threatening) |
| Tenderness at Site of Injection | 30 Days | Assessment of Tenderness on a 5 point scale (none, mild, moderate, severe or potentially life threatening) |
| Erythema at Site of Injection | 30 days | Assessment of Erythema on a 5 point scale (none, mild, moderate, severe or potentially life threatening) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of CBP-4888 | 30 days | Peak Plasma Concentration |
| AUC of CBP-4888 | 30 days | Area Under the Plasma Concentration Versus Time Curve |
| Tmax of CBP-4888 | 30 days | Time to maximum plasma concentration |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics | 30 days | Concentraion of sFLt-1 |
Countries
United States
Outcome results
None listed