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A Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621 in Adults With Recurrent Genital HSV-2 Infection.

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ClinicalTrials.gov Identifier: NCT03595995
Recruitment Status : Not yet recruiting
First Posted : July 23, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
United BioPharma

Brief Summary:
To evaluate the efficacy of two dose levels of UB-621 administration in reducing the HSV-2 genital shedding rate in patients with recurrent genital HSV-2 infection.

Condition or disease Intervention/treatment Phase
Genital Herpes Biological: UB-621 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Dose-ranging, Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621 on HSV Shedding in Adults With Recurrent Genital HSV-2 Infection.
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genital Herpes

Arm Intervention/treatment
Experimental: Cohort 1 Biological: UB-621
Monoclonal antibody by SC injection

Other: Placebo
The placebo is a sterile, clear and colorless or slightly yellow liquid, contains the same composition as UB-621 except drug substance. It is given by SC injection.

Experimental: Cohort 2 Biological: UB-621
Monoclonal antibody by SC injection

Other: Placebo
The placebo is a sterile, clear and colorless or slightly yellow liquid, contains the same composition as UB-621 except drug substance. It is given by SC injection.




Primary Outcome Measures :
  1. The change of HSV-2 shedding rate [ Time Frame: 112 days ]

Secondary Outcome Measures :
  1. The change of HSV-2 viral load [ Time Frame: 112 days ]
  2. The change of genital lesion rates [ Time Frame: 196 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03595995


Contacts
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Contact: Emily Chien +886-3-668-4800 ext 3617 emily.chien@unitedbiopharma.com
Contact: Annie Lai +886-3-668-4800 ext 3614 annie.lai@unitedbiopharma.com

Sponsors and Collaborators
United BioPharma

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Responsible Party: United BioPharma
ClinicalTrials.gov Identifier: NCT03595995     History of Changes
Other Study ID Numbers: UBP-A206-HSV
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Herpes Genitalis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female