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

NCT05881993 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: CBP-4888-100
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer Study

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Cmax of CBP-4888

  30 days

• AUC of CBP-4888

  30 days

• Tmax of CBP-4888

  30 days

Other Outcomes (1)

• Pharmacodynamics

  30 days

Study Arms (2)

CBP-4888

EXPERIMENTAL

CBP-4888 administered once as a subcutaneous dose.

Drug: CBP-4888

Placebo

PLACEBO COMPARATOR

Normal Saline administered once as a subcutaneous dose.

Other: Placebo

Interventions

CBP-4888 DRUG

siRNA therapeutic

CBP-4888

Placebo OTHER

Normal Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Comanche Biopharma: lead

Study Sites (1)

Comanche Biopharma Clinical Research Site #1

San Antonio, Texas, 78217, United States

Location

Study Officials

• Allison August, MD

  Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 31, 2023
• Study Start: May 22, 2023
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)