FIH Lead-in Study of YASO GEL Followed by a Phase 1 Randomized, Double-blind Study to Assess Safety and Pharmacokinetics of YASO GEL

Inclusion Criteria

• •4.1.1 Lead-in and Phase 1 Studies
• •Individuals who meet the following criteria are eligible for inclusion in the study (see additional gender specific criteria at the end of the section):
• •1. Adults who are:
• •* Women aged 18 through 45 years (inclusive)
• •* Men aged 18 years and over at Screening
• •2. Cisgender individuals with no history of gender reassignment impacting hormones or genital anatomy
• •3. Able to communicate in English
• •4. Provide written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
• •5. Willing and able to comply with all scheduled visits, treatment plans, laboratory tests and other study procedures.
• •6. Provide adequate locator information (per site SOP)
• •7. Understand and agree to local STI reporting requirements
• •8. In general good health, in the opinion of the investigator
• •9. Agree not to participate in other concurrent interventional and/or drug trials
• •Female specific criteria:
• •1. Women ≥ 21 years must have documentation of a satisfactory Pap within the past 3 years consistent with Grade 0 according to the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 (Dated November 2007) to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017, or satisfactory evaluation with no treatment required of Grade 1 or higher Pap result. If result is not available, Pap test will be performed at screening.
• •2. Regular menstrual cycles of approximately 21 to 35 days apart with no undiagnosed intermenstrual menstrual bleeding Note: This criterion is not applicable to participants using continuous combination oral contraceptive pills, patches, or progestin-only contraceptive methods (progestin-only pills, depot medroxyprogesterone acetate (DMPA), etonogestrel subdermal implant, or levonorgestrel-releasing IUD), as the absence of regular menstrual cycles and break-through bleeding are common in these contexts.
• •3. Using an effective method of contraception and intending to continue use of an effective method for the duration of study participation. Acceptable methods are:
• •* hormonal methods (except contraceptive vaginal rings)
• •* IUD
• •* sterilization of participant or partner
• •* heterosexual abstinence
• •* sexually abstinent for the past 90 days before enrollment and planning to remain abstinent for the duration of study participation
• •4. Must agree to abstain from insertion of anything other than IP into the vagina or anus (e.g., penis, tongue, finger, sex toy, lubricant, tampon, etc.) for at least 48 hours prior to the Enrollment Visit, the duration of treatment, and at least 48 hours after treatment.
• •Male specific criteria:
• •a. Must agree to abstain from:
• •Use of any genitally applied products other than IP (except soap/water for general hygiene and study provided condoms for at least 24 hours prior to treatment days and at least 48-hr after treatment
• •Masturbation or intercourse (anal, vaginal, or receptive oral) on treatment days and at least 48-hr after treatment
• •Heterosexual couples who meet the following criteria are eligible for inclusion in the study:
• •Couple-level criteria:
• •1. Women aged 18 through 45 years (inclusive) and men aged 18 through 55 years (inclusive) at screening
• •2. Provide written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
• •3. Willing and able to comply with all scheduled visits, treatment plans, laboratory tests and other study procedures.
• •4. Heterosexual couples in a mutually monogamous relationship ≥ 6 months prior to Screening with intent to remain in relationship for duration of study participation
• •5. Both partners willing to participate and coitally active
• •6. Cisgender individuals with no history of gender reassignment impacting hormones or genital anatomy
• •7. Both partners independently report not using barrier contraception and/or barrier protection as part of normal coital routine and report the intent to continue said sexual practice for the duration of study participation
• •8. Able to communicate in English
• •9. Provide adequate locator information, as defined in site SOP
• •10. Must be in general good health in the opinion of the investigator
• •11. Must agree to not to participate in other concurrent interventional and/or drug trials
• •1. Not pregnant or breastfeeding and not planning pregnancy during study participation
• •2. Women ≥ 21 years must have documentation of a satisfactory Pap within the past 3 years consistent with Grade 0 according to the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 (Dated November 2007) to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017, or satisfactory evaluation with no treatment required of Grade 1 or higher Pap result. If result is not available, Pap test will be performed at Screening.
• •3. Regular menstrual cycles of approximately 21 to 35 days apart with no undiagnosed intermenstrual menstrual bleeding Note: This criterion is not applicable to participants using continuous combination oral contraceptive pills, patches, or progestin-only contraceptive methods (progestin-only pills, depot medroxyprogesterone acetate (DMPA), etonogestrel subdermal implant, or levonorgestrel-releasing IUD), as the absence of regular menstrual cycles and break-through bleeding are common in these contexts.
• •4. Using an effective method of contraception and intending to continue use of an effective method for the duration of study participation. Acceptable methods are:
• •* hormonal methods (except contraceptive vaginal rings)
• •* IUD
• •* Female sterilization
• •5. Must agree to abstain from use of any vaginal products (e.g., lubricants, feminine hygiene products, sex toys, vaginally administered contraceptive products with the exception of study provided condoms) other than IP for at least 48 hours prior to coital visits and at least 48 hr after coital visits
• •1. Must agree to abstain from
• •* use of any genitally applied products, except soap/water for general hygiene, for at least 24 hours prior to coital visits and at least 48-hr after coital visits
• •* masturbation or intercourse (anal, vaginal, or receptive oral) for 72 hours before each coital visit.
• •2. Have no history of abnormal sperm or semen abnormality