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

Early Phase 1

Recruiting

• Conditions: Healthy Volunteer Study
• Interventions: Other: Placebo; Drug: CBP-4888

• Registration Number: NCT05881993
• Lead Sponsor: Comanche Biopharma

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.

Study Timeline

• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-05-19
• Study Start: 2023-05-22
• Study First Posted: 2023-05-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-24
• Primary Completion: 2024-03
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Normal Saline administered once as a subcutaneous dose.
CBP-4888	CBP-4888	CBP-4888 administered once as a subcutaneous dose.

Primary Outcome Measures

Name	Time	Method
Tenderness at Site of Injection	30 Days	Assessment of Tenderness on a 5 point scale (none, mild, moderate, severe or potentially life threatening)
Swelling at Site of Injection	30 Days	Assessment of Swelling 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)
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)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Comanche Biopharma Clinical Research Site #1; 🇺🇸 San Antonio, Texas, United States