Study of CBP-4888 in Healthy, Non-Pregnant Female Subjects
NCT ID: NCT05881993
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
45 participants
INTERVENTIONAL
2023-05-22
2024-05-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CBP-4888
CBP-4888 administered once as a subcutaneous dose.
CBP-4888
siRNA therapeutic
Placebo
Normal Saline administered once as a subcutaneous dose.
Placebo
Normal Saline
Interventions
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CBP-4888
siRNA therapeutic
Placebo
Normal Saline
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
50 Years
FEMALE
Yes
Sponsors
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Comanche Biopharma
INDUSTRY
Responsible Party
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Principal Investigators
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Allison August, MD
Role: STUDY_DIRECTOR
Chief Medical Officer
Locations
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Comanche Biopharma Clinical Research Site #1
San Antonio, Texas, United States
Countries
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Other Identifiers
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CBP-4888-100
Identifier Type: -
Identifier Source: org_study_id
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