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Completed

NCT Number: NCT05881993

Study 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.

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Key information

Conditions

Healthy Volunteer Study

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Comanche Biopharma Clinical Research Site #1

San Antonio, Texas, 78217, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBP-4888

Drug

siRNA therapeutic

Placebo

Other

Normal Saline

Primary outcomes

  1. Adverse Events

    Time frame: 30 days

    Number of participants with treatment-related adverse events

  2. 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)

  3. 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)

  4. 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)

  5. 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)

Secondary outcomes

  1. Cmax of CBP-4888

    Time frame: 30 days

    Peak Plasma Concentration

  2. AUC of CBP-4888

    Time frame: 30 days

    Area Under the Plasma Concentration Versus Time Curve

  3. Tmax of CBP-4888

    Time frame: 30 days

    Time to maximum plasma concentration

Other outcomes

  1. Pharmacodynamics

    Time frame: 30 days

    Concentraion of sFLt-1

Sponsors and collaborators

Lead sponsor

Comanche Biopharma

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 31, 2023
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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