UB-621, a New Type of Anti-herpes Simplex Virus (HSV) Monoclonal Antibody for the Use in the Treatment of Adult Recurrent HSV-2 Infections of the Genitals

Recurrent Genital Herpes Clinical Trial

Official title:

A Randomized, Single-blind, Dose-selected Phase II Trial to Evaluate the Safety and Efficacy of UB-621 in Adults With Recurrent Genital HSV-2 Infection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04714060
• Other study ID #: UBP-A228-HSV
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 1, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: May 2022
• Source: UBP Greater China (Shanghai) Co., Ltd
• Contact: Linda Shih, DVM
• Phone: +886 36684800
• Email: linda.shih[@]unitedbiopharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: January 31, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 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 period after the administration of study drug.

• Subject must be willing to go back to the hospital within 72 hours after the new lesions are shown in the anal and genital area.

• Subject must be willing to observe the syndromes around the anal and genital area during study period, to evaluate the lesions according to the HSV lesion score, and to record in the patient dairy

• Female subjects must have a negative serum ß-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.

• 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

• 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:

1. albumin<3 g/dl

2. ALP>2.5*ULN

3. ALT>2.5*ULN

4. AST>2.5*ULN

5. Bilirubin>1.5*ULN

6. CPK>1.5*ULN

7. rGGT>2.5*ULN

8. Hemoglobin: female<11 g/dl; male<12.5 g/dl

9. platelet<125*10E3/ul

10. WBC<2.5*10E3/ul or

11. ANC<1.5*10E3/ul

Related Conditions & MeSH terms

• Herpes Genitalis
• Recurrent Genital Herpes

Intervention

Biological:
• UB-621
mAb by SC administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UBP Greater China (Shanghai) Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HSV-2 shedding rate.	Viral shedding rate is defined as the number of positive anogenital swabs divided by total number of swabs.	8 weeks
Other	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.	8 weeks
Other	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.	8 weeks
Other	HSV-2 viral load	Anogenital swab samples collected from subjects during follow-up period will be used to quantify HSV-2 DNA copies.	8 weeks
Primary	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.	16 weeks
Secondary	Lesion rate	Lesion rate is calculated as the number of days with lesion divided by the number of study days.	16 weeks
Secondary	Duration of recurrent lesions	Duration of recurrent lesions is calculated as consecutive days with lesions of HSV score 2-7.	16 weeks
Secondary	Recurrence rate	Recurrence rate is defined as number of recurrences divided by the total number of study days.	16 weeks
Secondary	Time to first recurrence of lesion	Time to first recurrence of lesion as reported by patient and verified by investigator.	16 weeks