Study of CBP-4888 in Healthy, Non-Pregnant Female Subjects

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy Volunteer Study

Intervention / Treatment
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* Drug: CBP-4888
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBP-4888<br>CBP-4888 administered once as a subcutaneous dose. | Drug: CBP-4888<br>* siRNA therapeutic<br>|
| Placebo Comparator: Placebo<br>Normal Saline administered once as a subcutaneous dose. | Other: Placebo<br>* Normal Saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of participants with treatment-related adverse events | 30 days | 
| Pain at Site of Injection | Assessment of Pain on a 5 point scale (none, mild, moderate, severe or potentially life threatening) | 30 days | 
| Tenderness at Site of Injection | Assessment of Tenderness on a 5 point scale (none, mild, moderate, severe or potentially life threatening) | 30 Days | 
| Erythema at Site of Injection | Assessment of Erythema on a 5 point scale (none, mild, moderate, severe or potentially life threatening) | 30 days | 
| Swelling at Site of Injection | Assessment of Swelling on a 5 point scale (none, mild, moderate, severe or potentially life threatening) | 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of CBP-4888 | Peak Plasma Concentration | 30 days | 
| AUC of CBP-4888 | Area Under the Plasma Concentration Versus Time Curve | 30 days | 
| Tmax of CBP-4888 | Time to maximum plasma concentration | 30 days |