Trials / Not Yet Recruiting
Not Yet RecruitingNCT04979975
Evaluating Safety and Efficacy of Repeat Doses of UB-621in Adult Patients With Recurrent Genital Herpes
A Randomized, Single-blind, Placebo-control, Parallel, Phase II Trial to Evaluate the Safety and Efficacy of UB-621 in Adults With Recurrent Genital HSV-2 Infection
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- UBP Greater China (Shanghai) Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the efficacy of repeat-dose UB-621 for the recurrent genital HSV-2 infection To evaluate the safety and tolerance of repeat-dose UB-621 for the recurrent HSV-2 infection To evaluate the pharmacokinetics of repeat-dose UB-621 in RGH patients
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Placebo | PBO- placebo matching to UB-621 |
| BIOLOGICAL | UB-621 low-dose | fully human anti-HSV mAb |
| BIOLOGICAL | UB-621 high-dose | fully human anti-HSV mAb |
Timeline
- Start date
- 2023-12-01
- Primary completion
- 2025-12-01
- Completion
- 2026-12-01
- First posted
- 2021-07-28
- Last updated
- 2022-10-03
Source: ClinicalTrials.gov record NCT04979975. Inclusion in this directory is not an endorsement.