Safety and Tolerability Studies of CanProFem-AK, Vaginal Suppositories in Healthy Volunteers
NCT Number: NCT06535126
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Candidosis Vaginal
Interventions: DRUG: CanProFem-AK
Sponsor: Industrial Microbiology LLP
Sex: FEMALE
Age: ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2024-06-02
Locations: MIPO Clinic LLP, Almaty, Kazakhstan

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.

Primary Outcome Measures: General indicators for safety evaluation of a studied drug:, * Absence of allergic reactions and clinically significant changes in blood count
* Analysis of biochemical blood test indicators
* Complete blood count with white blood cell count, and complete urine analysis
* Absence of changes in the general somatic condition of volunteers during the study period (physical examination). Absence of side effects., 24 hours|Tolerability of the studied drug, The degree of tolerability of the studied drug will be determined by three gradations:

* Intolerance: The appearance of local signs of allergy/pseudoallergy and systemic signs, such as tachycardia (heart rate over 90 per minute for 30 minutes after administration), decreased blood pressure (less than 100/60 mm Hg for 30 minutes after application), or serious adverse drug reactions.
* Absence of adverse drug reactions (side effects).
* Adverse drug reactions (side effects) not classified as serious., 24 hours