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

• ClinicalTrials.gov Identifier: NCT05881993
• Recruitment Status: Recruiting
• First Posted: May 31, 2023
• Last Update Posted: January 24, 2024
• Sponsor: Comanche Biopharma
• Information provided by (Responsible Party): Comanche Biopharma

Tracking Information

• First Submitted Date: May 9, 2023
• First Posted Date: May 31, 2023
• Last Update Posted Date: January 24, 2024
• Actual Study Start Date: May 22, 2023
• Estimated Primary Completion Date: March 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 19, 2023)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 19, 2023)

• Cmax of CBP-4888 [ Time Frame: 30 days ]
  Peak Plasma Concentration
• AUC of CBP-4888 [ Time Frame: 30 days ]
  Area Under the Plasma Concentration Versus Time Curve
• Tmax of CBP-4888 [ Time Frame: 30 days ]
  Time to maximum plasma concentration

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: May 19, 2023)

Pharmacodynamics [ Time Frame: 30 days ]

Concentraion of sFLt-1

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Study of CBP-4888 in Healthy, Non-Pregnant Female Subjects
• 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
• Brief 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.
• Study Type: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Healthy Volunteer Study

Intervention

• Drug: CBP-4888
  siRNA therapeutic
• Other: Placebo
  Normal Saline

Study Arms

• Experimental: CBP-4888
  CBP-4888 administered once as a subcutaneous dose.
  Intervention: Drug: CBP-4888
• Placebo Comparator: Placebo
  Normal Saline administered once as a subcutaneous dose.
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 19, 2023): 15
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2024
• Estimated Primary Completion Date: March 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: females

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Jim Joffrion; 800-876-8619; jim@comanchebiopharma.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05881993
• Other Study ID Numbers: CBP-4888-100
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Comanche Biopharma
• Original Responsible Party: Same as current
• Current Study Sponsor: Comanche Biopharma
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Allison August, MD; Chief Medical Officer

• PRS Account: Comanche Biopharma
• Verification Date: January 2024