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

NCT ID: NCT05881993

Last Updated: 2025-09-26

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-22

Study Completion Date

2024-05-22

Brief Summary

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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

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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.

Conditions

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Healthy Volunteer Study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CBP-4888

CBP-4888 administered once as a subcutaneous dose.

Group Type EXPERIMENTAL

CBP-4888

Intervention Type DRUG

siRNA therapeutic

Placebo

Normal Saline administered once as a subcutaneous dose.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Normal Saline

Interventions

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CBP-4888

siRNA therapeutic

Intervention Type DRUG

Placebo

Normal Saline

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Comanche Biopharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Other Identifiers

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CBP-4888-100

Identifier Type: -

Identifier Source: org_study_id

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