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

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteer Study

In brief

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.

Key facts

Study ID

NCT05881993

Run by

Comanche Biopharma

People needed

45

Starts

2023-05-22

Expected to finish

2024-05-22

Last updated by the study team

2025-09-26

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Comanche Biopharma Clinical Research Site #1 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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