Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535126
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Safety and Tolerability Studies of CanProFem-AK Vaginal Suppositories in Healthy Volunteers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Tolerability Studies of CanProFem-AK Vaginal Suppositories in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
The study object of this clinical trial is CanProFem-AK 100 mg suppositories The Pharmacological group - Antifungal drug for external use
Fungal infections are one of the most demanding and unresolved problems of modern medicine The number of fungal infections is growing due to the increase in the number of people with immunodeficiency diseases oncohematological pathology organ transplants nursing newborns the coronavirus pandemic while the role of fungi that were previously considered non-pathogenic is increasing Among fungal diseases candidiasis caused by fungi of the genus Candida is of particular importance Genital vulvovaginal candidiasis is a very common phenomenon Taking into account the prevalence of candidiasis as well as numerous cases of resistance of pathogenic fungi to drugs an urgent task is to create new domestic effective antifungal drugs for their treatment
Scientists from the Research and Production Center of Microbiology and Virology developed a new pharmaceutical antifungal drug CanProFem-AK in the form of a suppository for the treatment of vaginal candidal infections The active drug substance is the original antifungal antibiotic Roseofungin produced by a strain of soil microorganism that has high activity against pathogenic fungi - causative agents of human mycoses Preclinical trials of the drug shown its safety and effectiveness in the treatment of vaginal candidiasis The trials demonstrated that the drug exhibits high antifungal activity therapeutic efficacy and safety in use
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 were 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
Study design open-label single-centre phase I clinical trial Dosage regimen vaginal administration of one suppository of the studied drug CanProFem-AK 100 mg 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 Repeated blood and urine laboratory 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
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
Statistical analysis of the data is carried out based on the result of collecting the anamnestic and clinical data as well as laboratory and instrumental research data In addition the volume of consultations examinations and concomitant treatment before the study is also recordedData will be collected using an approved form - the Individual Registration Card
Ethical and legal issues in clinical research This clinical trial will be conducted following the principles established by the 18th World Medical Assembly Helsinki 1964 and the ICH guidelines for good clinical practice GCP It will be conducted in compliance with all relevant international laws and guidelines as well as the national laws and regulations of the countries where it is conducted
Data Collection Record Keeping and Storage Data collection will be conducted electronically and to some extent on paper
The investigator is responsible for maintaining the confidentiality of all trial documentation whether electronic or paper and must implement measures to prevent accidental or premature destruction of this documentation
All trial documentation must be retained for at least fifteen 15 years after the completion or premature termination of the clinical trial If a longer retention period is mandated applicable legal requirements must be taken into account
Before destroying any important trial documents the investigator must notify the sponsor following the completion or premature termination of the clinical trial
Financing and insurance All financing and insurance matters will be outlined in the agreement between the Sponsor and the Contractor
Publications Investigator agrees not to publish or disclose the study andor its results without prior written permission from the study sponsor provided that the sponsor will not withhold such permission without a valid reason The researcher will not use the sponsors name in any advertising materials or publications without the sponsors prior written consent Likewise the sponsor will not use the investigators or their staffs names in advertising materials or publications without first obtaining their written consent The sponsor retains the right to publish the study results at any time
Fungal infections are one of the most demanding and unresolved problems of modern medicine The number of fungal infections is growing due to the increase in the number of people with immunodeficiency diseases oncohematological pathology organ transplants nursing newborns the coronavirus pandemic while the role of fungi that were previously considered non-pathogenic is increasing Among fungal diseases candidiasis caused by fungi of the genus Candida is of particular importance Genital vulvovaginal candidiasis is a very common phenomenon Taking into account the prevalence of candidiasis as well as numerous cases of resistance of pathogenic fungi to drugs an urgent task is to create new domestic effective antifungal drugs for their treatment
Scientists from the Research and Production Center of Microbiology and Virology developed a new pharmaceutical antifungal drug CanProFem-AK in the form of a suppository for the treatment of vaginal candidal infections The active drug substance is the original antifungal antibiotic Roseofungin produced by a strain of soil microorganism that has high activity against pathogenic fungi - causative agents of human mycoses Preclinical trials of the drug shown its safety and effectiveness in the treatment of vaginal candidiasis The trials demonstrated that the drug exhibits high antifungal activity therapeutic efficacy and safety in use
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 were 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
Study design open-label single-centre phase I clinical trial Dosage regimen vaginal administration of one suppository of the studied drug CanProFem-AK 100 mg 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 Repeated blood and urine laboratory 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
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
Statistical analysis of the data is carried out based on the result of collecting the anamnestic and clinical data as well as laboratory and instrumental research data In addition the volume of consultations examinations and concomitant treatment before the study is also recordedData will be collected using an approved form - the Individual Registration Card
Ethical and legal issues in clinical research This clinical trial will be conducted following the principles established by the 18th World Medical Assembly Helsinki 1964 and the ICH guidelines for good clinical practice GCP It will be conducted in compliance with all relevant international laws and guidelines as well as the national laws and regulations of the countries where it is conducted
Data Collection Record Keeping and Storage Data collection will be conducted electronically and to some extent on paper
The investigator is responsible for maintaining the confidentiality of all trial documentation whether electronic or paper and must implement measures to prevent accidental or premature destruction of this documentation
All trial documentation must be retained for at least fifteen 15 years after the completion or premature termination of the clinical trial If a longer retention period is mandated applicable legal requirements must be taken into account
Before destroying any important trial documents the investigator must notify the sponsor following the completion or premature termination of the clinical trial
Financing and insurance All financing and insurance matters will be outlined in the agreement between the Sponsor and the Contractor
Publications Investigator agrees not to publish or disclose the study andor its results without prior written permission from the study sponsor provided that the sponsor will not withhold such permission without a valid reason The researcher will not use the sponsors name in any advertising materials or publications without the sponsors prior written consent Likewise the sponsor will not use the investigators or their staffs names in advertising materials or publications without first obtaining their written consent The sponsor retains the right to publish the study results at any time
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None