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Safety and Tolerability Studies of CanProFem-AK, Vaginal Suppositories in Healthy Volunteers

NCT06535126 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-08-02

No results posted yet for this study

Summary

The study object of this clinical trial is CanProFem-AK, 100 mg suppositories. The Pharmacological group - Antifungal drug for external use. The active drug substance is the antifungal antibiotic Roseofungin 100 mg, which was developed at the "Research and Production Center of Microbiology and Virology".

According to the aims and objectives of the phase I clinical trial, the primary parameter is the study of safety and tolerability throughout the entire duration of the trial.

The phase I clinical trial of the drug CanProFem-AK 100 mg included 20 healthy female participants aged 18 to 40 years, who are on 6-12 days of their menstrual cycle. The clinical and laboratory parameters to characterize the safety of the drug: specific clinical signs and symptoms of particular importance, medical history, physical examination, biochemical analysis of blood, complete blood count with white blood cell count, and complete urine analysis.

Selection and Exclusion of Subjects: Before inclusion in a clinical trial, each participant must first sign an Informed Consent Form for Participation in the Study, followed by a screening examination, including a variety of procedures, medical history, and physical examination. Each participant in the trial will be assigned an identification number.

Study Design: open-label, single-centre, phase I clinical trial. The total duration of participation in a study is one day. The administration scheme of the drug includes the vaginal insertion of one suppository for each participant, followed by medical observation of the participants' conditions at 3, 6, 9, 12 and 24 hours after administration.

The tolerability of the drug will be assessed based on the reported participants' symptoms and sensations, and objective data obtained by the researcher during the study. The frequency and nature of adverse reactions will also be taken into account. The degree of tolerability of the study drug will be determined by three gradations: intolerance, absence of adverse drug reactions (side reactions), and adverse drug reactions (side effects) not classified as serious.

This clinical trial will be conducted following the principles formulated by the 18th World Medical Assembly (Helsinki, 1964) and the ICH guidelines for good clinical practice (GCP), as well as with all international and national laws and guidelines.

Conditions

  • Candidosis Vaginal

Interventions

DRUG

CanProFem-AK

Dosage form - vaginal suppositories (100 mg). Dosage regimen - single intravaginal administration of suppository. Vaginal suppositories are inserted as deeply as possible while the participant is lying down; the participant must remain in a horizontal position for 45 minutes after the administration. The total duration of volunteer participation in the study is one day. Medical observation (including gynaecological monitoring with vaginal bacterial swab test) of the subject condition after the drug administration will be carried out after 3, 6, 9, 12 and 24 hours. Repeated laboratory blood and urine tests will be performed after 24 hours. Participants of the study will be closely monitored for 24 hours after the initial administration of the drug to detect any immediate adverse events. If the subject experiences an immediate adverse event, appropriate treatment will be provided.

Sponsors & Collaborators

  • Industrial Microbiology LLP

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2024-06-02
Completion
2024-06-02

Countries

  • Kazakhstan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06535126 on ClinicalTrials.gov