A Phase 2 interventional study of UB-621 in Recurrent Genital Herpes, sponsored by UBP Greater China (Shanghai) Co., Ltd. Status unknown. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by UBP Greater China (Shanghai) Co., Ltd · Phase 2, Interventional, and Treatment
A randomized, single-blind, dose-selected phase II trial to evaluate the safety, efficacy and PK of UB-621 in adults with recurrent genital HSV-2 infection
70 studies on the registry are indexed under Herpes Genitalis; 3 are open to participants now.
This study's planned enrollment of 44 is below the median of 103 across 53 interventional studies indexed under Herpes Genitalis.
Browse Herpes Genitalis studies →UBP Greater China (Shanghai) Co., Ltd is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Abnormal blood tests according to "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial "in the Guidance for Industry, 2007:
2.5 mg/kg UB-621 group
Biological: UB-621
5 mg/kg UB-621 group
Biological: UB-621
mAb by SC administration
Proportion of subjects with episodes before and after UB-621 treatment (self-comparison)
Proportion of subjects with episodes is calculated as the number of subjects with episodes divided by the number of total subjects. Primary endpoint is the self-comparison of proportion of subjects with episodes before and after UB-621 treatment.
Time frame: 16 weeks
Lesion rate
Lesion rate is calculated as the number of days with lesion divided by the number of study days.
Time frame: 16 weeks
Duration of recurrent lesions
Duration of recurrent lesions is calculated as consecutive days with lesions of HSV score 2-7.
Time frame: 16 weeks
Recurrence rate
Recurrence rate is defined as number of recurrences divided by the total number of study days.
Time frame: 16 weeks
Time to first recurrence of lesion
Time to first recurrence of lesion as reported by patient and verified by investigator.
Time frame: 16 weeks
HSV-2 shedding rate.
Viral shedding rate is defined as the number of positive anogenital swabs divided by total number of swabs.
Time frame: 8 weeks
Clinical and Subclinical HSV-2 Shedding Rates
Daily record of subject self-assessment of genital lesions in subject diary in addition to anogenital swabs collected daily from subjects during the follow-up periods will be used to evaluate the clinical (lesional) and subclinical (non-lesional) HSV-2 shedding rates.
Time frame: 8 weeks
Rate of HSV-2 Shedding Episodes
The rate of HSV-2 shedding episodes is the number of onsets of shedding episodes divided by the total number of days with swabs collected. Shedding episodes are defined as consecutive HSV-2 positive swab results including no more than 1 consecutive negative result or missed swab. The episodes are preceded and followed by 2 consecutive negative swab results.
Time frame: 8 weeks
HSV-2 viral load
Anogenital swab samples collected from subjects during follow-up period will be used to quantify HSV-2 DNA copies.
Time frame: 8 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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UBP Greater China (Shanghai) Co., Ltd