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

Healthy Volunteer Study Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05881993
• Other study ID #: CBP-4888-100
• Status: Recruiting
• Phase: Early Phase 1
• Start date: May 22, 2023
• Est. completion date: April 2024

Study information

• Verified date: January 2024
• Source: Comanche Biopharma
• Contact: Jim Joffrion
• Phone: 800-876-8619
• Email: jim[@]comanchebiopharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer Study

Intervention

Drug:
• CBP-4888
siRNA therapeutic

Other:
• Placebo
Normal Saline

Locations

Country	Name	City	State
United States	Comanche Biopharma Clinical Research Site #1	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Comanche Biopharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pharmacodynamics	Concentraion of sFLt-1	30 days
Primary	Adverse Events	Number of participants with treatment-related adverse events	30 days
Primary	Pain at Site of Injection	Assessment of Pain on a 5 point scale (none, mild, moderate, severe or potentially life threatening)	30 days
Primary	Tenderness at Site of Injection	Assessment of Tenderness on a 5 point scale (none, mild, moderate, severe or potentially life threatening)	30 Days
Primary	Erythema at Site of Injection	Assessment of Erythema on a 5 point scale (none, mild, moderate, severe or potentially life threatening)	30 days
Primary	Swelling at Site of Injection	Assessment of Swelling on a 5 point scale (none, mild, moderate, severe or potentially life threatening)	30 Days
Secondary	Cmax of CBP-4888	Peak Plasma Concentration	30 days
Secondary	AUC of CBP-4888	Area Under the Plasma Concentration Versus Time Curve	30 days
Secondary	Tmax of CBP-4888	Time to maximum plasma concentration	30 days