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

NCT04714060 | Unknown Phase 2

• 1 other identifier: UBP-A228-HSV
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Recurrent Genital Herpes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Lesion rate

  16 weeks

• Duration of recurrent lesions

  16 weeks

• Recurrence rate

  16 weeks

• Time to first recurrence of lesion

  16 weeks

Other Outcomes (4)

• HSV-2 shedding rate.

  8 weeks

• Clinical and Subclinical HSV-2 Shedding Rates

  8 weeks

• Rate of HSV-2 Shedding Episodes

  8 weeks

Study Arms (2)

cohort 1

EXPERIMENTAL

2.5 mg/kg UB-621 group

Biological: UB-621

cohort 2

EXPERIMENTAL

5 mg/kg UB-621 group

Biological: UB-621

Interventions

UB-621 BIOLOGICAL

mAb by SC administration

cohort 1; cohort 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 β-HCG at Screening and a negative urine pregnancy test prior to study drug administration.

You may not qualify if:

• 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:
• albumin\<3 g/dl
• ALP\>2.5\*ULN
• ALT\>2.5\*ULN
• AST\>2.5\*ULN
• Bilirubin\>1.5\*ULN

Sponsors & Collaborators

• UBP Greater China (Shanghai) Co., Ltd: lead

MeSH Terms

Conditions

Herpes Genitalis

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases

Central Study Contacts

Linda Shih, DVM

CONTACT

+886 36684800; linda.shih@unitedbiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 19, 2021
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: January 31, 2025
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share