A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CBP-4888 in Healthy, Non-Pregnant Female Subjects
Overview
- Phase
- Early Phase 1
- Intervention
- CBP-4888
- Conditions
- Healthy Volunteer Study
- Sponsor
- Comanche Biopharma
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Tenderness at Site of Injection
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
CBP-4888
CBP-4888 administered once as a subcutaneous dose.
Intervention: CBP-4888
Placebo
Normal Saline administered once as a subcutaneous dose.
Intervention: Placebo
Outcomes
Primary Outcomes
Tenderness at Site of Injection
Time Frame: 30 Days
Assessment of Tenderness on a 5 point scale (none, mild, moderate, severe or potentially life threatening)
Swelling at Site of Injection
Time Frame: 30 Days
Assessment of Swelling on a 5 point scale (none, mild, moderate, severe or potentially life threatening)
Erythema at Site of Injection
Time Frame: 30 days
Assessment of Erythema on a 5 point scale (none, mild, moderate, severe or potentially life threatening)
Adverse Events
Time Frame: 30 days
Number of participants with treatment-related adverse events
Pain at Site of Injection
Time Frame: 30 days
Assessment of Pain on a 5 point scale (none, mild, moderate, severe or potentially life threatening)
Secondary Outcomes
- Cmax of CBP-4888(30 days)
- AUC of CBP-4888(30 days)
- Tmax of CBP-4888(30 days)