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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05881993
Recruitment Status : Recruiting
First Posted : May 31, 2023
Last Update Posted : January 24, 2024
Sponsor:
Information provided by (Responsible Party):
Comanche Biopharma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Study Drug: CBP-4888 Other: Placebo Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 22, 2023
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : April 2024
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Pharmacodynamics [ Time Frame: 30 days ]
    Concentraion of sFLt-1


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   females
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05881993


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

Locations
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United States, Texas
Comanche Biopharma Clinical Research Site #1 Recruiting
San Antonio, Texas, United States, 78217
Contact: Recruitment Department    210-635-1515    participate@worldwide.com   
Sponsors and Collaborators
Comanche Biopharma
Investigators
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Study Director: Allison August, MD Chief Medical Officer
More Information
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Responsible Party: Comanche Biopharma
ClinicalTrials.gov Identifier: NCT05881993    
Other Study ID Numbers: CBP-4888-100
First Posted: May 31, 2023    Key Record Dates
Last Update Posted: January 24, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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