A Double-blind, Randomised, Placebo-controlled, Dose Escalation Trial to Evaluate the Safety and to Assess Local and Systemic Pharmacokinetics of DS003 Vaginal Tablets Administered to Healthy HIV-negative Women

International Partnership for Microbicides, Inc.0 sites36 target enrollmentNovember 18, 2015

ConditionsHIV

InterventionsDS003 vaginal tablet Placebo

Overview

Phase: Phase 1
Intervention: DS003 vaginal tablet
Conditions: HIV
Sponsor: International Partnership for Microbicides, Inc.
Enrollment: 36
Primary Endpoint: To evaluate the safety of three escalating doses of DS003 (1 mg, 3 mg and 10 mg), administered in a vaginal tablet formulation, to healthy, HIV-negative female volunteers.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

A double-blind, randomised, placebo-controlled, dose escalation trial to evaluate the safety and to assess local and systemic pharmacokinetics of ds003 vaginal tablets administered to healthy HIV-negative women.

Registry

clinicaltrials.gov

Start Date

November 18, 2015

End Date

August 26, 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Female

Investigators

Sponsor

International Partnership for Microbicides, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Women must meet all of the following criteria to be eligible for enrolment:
•Women ≥ 18 and ≤ 45 years of age who can give written informed consent
•BMI of ≥ 18 and \< 30 kg/m2
•Vital signs within normal limits and no clinically significant ECG findings
•Available for all visits and consent to follow all procedures scheduled for the trial
•Healthy, based on medical history, vital signs, physical examination, urinalysis (dipstick and microscopy), laboratory evaluations for genital infections (bacterial vaginosis, gonorrhoea, chlamydia and trichomonas) and laboratory evaluations for haematology and biochemistry
•HIV-negative as determined by an HIV test at the time of screening
•On a stable form of contraception, defined as:
•A stable oral contraceptive regimen for at least 2 months prior to enrolment, OR
•Transdermal contraceptive patch for at least 3 months prior to enrolment, OR

Exclusion Criteria

•Women who meet any of the exclusion criteria below are not eligible:
•Currently pregnant or had their last pregnancy outcome within 3 months prior to screening
•Currently breast-feeding
•Currently or within 2 months of participation in any other clinical research trial involving investigational or marketed products prior to screening
•Untreated symptomatic urogenital infections, e.g. urinary tract or other sexually transmitted infections, or other gynaecological conditions such as vaginal itching, pain, or discharge, prior to enrolment
•Have a Grade 2 or higher pelvic examination finding, according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events; Addendum 1 Female Genital Grading Table for Use in Microbicide Studies
•History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction, incontinence or urge incontinence
•Current vulvar or vaginal symptoms/abnormalities that could influence the trial results
•Cervical cytology at screening that requires cryotherapy, biopsy, treatment, or further evaluation
•Symptomatic genital herpes simplex virus (HSV) infection or a history of genital herpetic infection

Arms & Interventions

DS003 vaginal tablet

participants will be randomised in a 3:1 ratio to receive either DS003 or placebo on Day 0 and Day 17.

Intervention: DS003 vaginal tablet

placebo

participants will be randomised in a 3:1 ratio to receive either DS003 or placebo on Day 0 and Day 17.

Intervention: Placebo

Outcomes

Primary Outcomes

To evaluate the safety of three escalating doses of DS003 (1 mg, 3 mg and 10 mg), administered in a vaginal tablet formulation, to healthy, HIV-negative female volunteers.

Time Frame: 12 weeks

Gynaecological assessments, including pelvic examination and colposcopy

Secondary Outcomes

To assess the local (vaginal fluids) and systemic (plasma) DS003 PK profile and the 24 hour cervical tissue concentration when administered in three escalating doses of a vaginal tablet formulation.(12 weeks)