COMPLETED

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-05-22

Study Completion:2024-05-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05881993

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Principal Investigator

Allison August, MD

STUDY_DIRECTOR

Chief Medical Officer

Study Locations (Sites)

Comanche Biopharma Clinical Research Site #1

San Antonio, Texas, 78217

United States

Collaborators and Investigators

Sponsor: Comanche Biopharma

Allison August, MD, STUDY_DIRECTOR, Chief Medical Officer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-22

Study Completion Date2024-05-22

Study Record Updates

Study Start Date2023-05-22

Study Completion Date2024-05-22

Terms related to this study

Additional Relevant MeSH Terms

Healthy Volunteer Study