Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-24 @ 2:06 PM
NCT ID:
NCT03595995
Eligibility Criteria:
Inclusion Criteria:
* Subject must be at least 18 years of age inclusive.
* Subject must be HSV-2 seropositive
* Subjects have a history of recurrent genital herpes in the past year
* Subjects have a negative result on the HIV Ab/Ag assay
* Subjects must agree to use contraception during study participation
* Subjects must be willing NOT to use any topical genital therapy and systemic anti-HSV therapy from the beginning of the study till the end of week 16.
* Subjects must be willing to collect a swab each day from their genital area (non-lesional as well as lesional, if appropriate) during the swabbing periods, which are 8 weeks prior to and upon the administration of study drug.
* Female subjects must have a negative serum β-HCG at Screening and a negative urine pregnancy test prior to study drug administration.
Exclusion Criteria:
* Serious medical conditions, including poorly controlled diabetes, significant autoimmune diseases, co-existing sexually transmitted disease presentation (except HSV) in the anogenital area, etc. that may interfere with the assessment of the efficacy of UB-621.
* Documented HSV resistance to acyclovir, valacyclovir, famciclovir, or penciclovir
* History or current evidence of malignancy except for a localized non-melanoma skin cancer
* Known immunosuppression
* Exposure to HSV vaccine
* Medical history of macular or maculopapular skin reactions to antibody (ie, as evidenced by IgG or plasma administration)
* Any other conditions that in the judgment of the Investigator would preclude successful completion of the clinical study
* Treatment with systemic steroids or other immunomodulating agents within 30 days prior to Screening or planned treatment with systemic steroids or immunomodulators during the study period.
* Renal impairment and/or hepatic impairment
* ECG abnormalities of clinical relevance or cardiovascular conditions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03595995
Study Brief:
Protocol Section:
NCT03595995