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

NCT06535126 | Completed Phase 1

• 1 other identifier: ПМ-002-23г
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

phase I of clinical trial; Candida; antifungal drug; antibiotic; suppository

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Healthy Volunteers

EXPERIMENTAL

The drug administration scheme involves vaginal administration of one suppository (CanProFem-AK, 100 mg). The total duration of participation in a study is one day.

Drug: CanProFem-AK

Interventions

CanProFem-AK DRUG

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.

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy female volunteers aged 18-40 years with verified health status and no chronic or acute systemic or dermatological diseases.
• Willingness to voluntarily participate in the study.

You may not qualify if:

• Individuals with chronic diseases (tuberculosis, hepatitis, HIV infection, diabetes mellitus, cancer), chronic renal failure, chronic liver failure, exacerbations of chronic diseases;
• Individuals participating in parallel clinical trials of other drugs, or who participated within 3 months from the start of the current study;
• Individuals from the category of "vulnerable patients" (homeless, military personnel, incapacitated persons, patients in emergency situations, and other individuals who may be the subject of pressure);
• Patients with an allergy in their medical history and during screening (medicinal, pollen and other types);
• Patients with a history of oncopathology or a family history of oncopathology (the presence of oncopathology among close relatives);
• Patients with hypersensitivity to one of the components of the study drug;
• Pregnancy and breastfeeding;
• Patient's refusal to perform the procedures required by the protocol and inability to adhere to the procedure schedule.

Sponsors & Collaborators

• Industrial Microbiology LLP: lead

Study Sites (1)

MIPO Clinic LLP

Almaty, Kazakhstan

Location

Related Publications (3)

• Ongarbayeva N., Balgimbayeva А., Baimakhanova B., Sadanov А., Lakhk O., Orazymbet S., Trenozhnikova L., Berezin V., Bogoyavlenskiy A. Pharmacotherapy for vulvovaginal candidiasis // Microbiology and Virology. - 2024. - 2(45). - pp. 83-107. https://doi.org/10.53729/MV-AS.2024.02.06

  BACKGROUND

• Sadanov A.K., Ibragimova L.N., Balgimbayeva A.S., Trenozhnikova L.P., Tugelbay G.E., Berezin V.E., Turlybaeva Z.Zh. Suppositories with antifungal and antiviral activity. - Utility patent No. 5056 dated 10/09/2020.

  BACKGROUND

• Certificate for the Trademark "КанПроФем-АК/CanProFem-AK", No. 69692 dated July 30, 2020.

  BACKGROUND

MeSH Terms

Conditions

Candidiasis, Vulvovaginal; Torulopsis

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Objectives of the study: Determine the safety and tolerability of CanProFem-AK, 100 mg suppositories in healthy volunteers. The study includes the following stages: Stage 1 of the study (introductory stage) included recruitment and screening of healthy volunteers - study participants, signing of informed consent, medical examination and laboratory tests. Stage 2 of the study (baseline control stage) involved clinical measurements taken before the start of the study (baseline measurements) for each subject. These measurements were conducted to obtain baseline data, which were then compared with the results obtained after the study's conclusion. Stage 3 of the study included medical observation after the vaginal administration of one suppository, including gynecological examination and bacterial culture sampling from the vagina at 3, 6, 9, 12, and 24 hours. Additional blood and urine tests will be performed after 24 hours.

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 2, 2024
• Study Start: June 1, 2024
• Primary Completion: June 2, 2024
• Study Completion: June 2, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)