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

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.

Conditions

Healthy Volunteer Study

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Healthy Volunteer Study
Intervention / Treatment

-

Contacts and Locations

San Antonio

Comanche Biopharma Clinical Research Site #1, San Antonio, Texas, United States, 78217

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Comanche Biopharma,

Allison August, MD, STUDY_DIRECTOR, Chief Medical Officer

Study Record Dates

2024-04