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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteer Study
• Intervention / Treatment: Other: Placebo; Drug: 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 Type: Interventional
• Enrollment (Estimated): 15
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jim Joffrion; Phone Number: 800-876-8619; Email: jim@comanchebiopharma.com

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78217
      • Recruiting
      • Comanche Biopharma Clinical Research Site #1
      • Contact: Recruitment Department; Phone Number: 210-635-1515; Email: participate@worldwide.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBP-4888; CBP-4888 administered once as a subcutaneous dose.	Drug: CBP-4888; siRNA therapeutic
Placebo Comparator: Placebo; Normal Saline administered once as a subcutaneous dose.	Other: Placebo; Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Number of participants with treatment-related adverse events	30 days
Pain at Site of Injection	Assessment of Pain on a 5 point scale (none, mild, moderate, severe or potentially life threatening)	30 days
Tenderness at Site of Injection	Assessment of Tenderness on a 5 point scale (none, mild, moderate, severe or potentially life threatening)	30 Days
Erythema at Site of Injection	Assessment of Erythema on a 5 point scale (none, mild, moderate, severe or potentially life threatening)	30 days
Swelling at Site of Injection	Assessment of Swelling on a 5 point scale (none, mild, moderate, severe or potentially life threatening)	30 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of CBP-4888	Peak Plasma Concentration	30 days
AUC of CBP-4888	Area Under the Plasma Concentration Versus Time Curve	30 days
Tmax of CBP-4888	Time to maximum plasma concentration	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacodynamics	Concentraion of sFLt-1	30 days

Collaborators and Investigators

• Sponsor: Comanche Biopharma
• Investigators: Study Director: Allison August, MD, Chief Medical Officer

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CBP-4888-100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No