NCT05881993

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Comanche Biopharma · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteer Study

Interventions

Type	Name	Description
DRUG	CBP-4888	siRNA therapeutic
OTHER	Placebo	Normal Saline

Timeline

• Start date: 2023-05-22
• Primary completion: 2024-05-22
• Completion: 2024-05-22
• First posted: 2023-05-31
• Last updated: 2025-09-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study