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A Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621

NCT03595995 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-10-03

No results posted yet for this study

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.

Conditions

  • Genital Herpes

Interventions

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.

Sponsors & Collaborators

  • United BioPharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-06-30
Completion
2024-06-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03595995 on ClinicalTrials.gov