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

Comanche Biopharma

Status and phase: Completed; Early Phase 1

Conditions: Healthy Volunteer Study

Treatments: Other: Placebo; Drug: CBP-4888

Study type: Interventional

Funder types: Industry

Identifiers

NCT05881993

CBP-4888-100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

45 participants in 2 patient groups, including a placebo group

CBP-4888

Experimental group

Description:

CBP-4888 administered once as a subcutaneous dose.

Treatment:

Drug: CBP-4888

Placebo

Placebo Comparator group

Description:

Normal Saline administered once as a subcutaneous dose.

Treatment:

Other: Placebo