Study of WPV01 in Healthy Subjects
NCT06205329 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 108
Last updated 2024-06-13
Summary
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WPV01 and WPV01 Co-administrated With Ritonavir in Healthy Adult Subjects.
Conditions
- Healthy Participants
Interventions
- DRUG
-
WPV01 Dose 1-4
WPV01 Dose 1-4 or Placebo on day 1
- DRUG
-
WPV01 Dose 5-8 and Ritonavir
WPV01 Dose 5-8 and Ritonavir or Placebo on day 1
- DRUG
-
WPV01 Dose 9-12
WPV01 Dose 9-12 or Placebo from day 1 to day 6
- DRUG
-
WPV01 Dose 13-15 and Ritonavir
WPV01 Dose 13-15 and Ritonavir or Placebo from day 1 to day 6
- DRUG
-
WPV01 Dose 16
Cohort 1:WPV01 Dose 16 or Placebo (with high fat meal) Cohort 2:WPV01 Dose 16 or Placebo (fasted)
Sponsors & Collaborators
-
Westlake Pharmaceuticals (Hangzhou) Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-10-03
- Primary Completion
- 2023-03-11
- Completion
- 2023-07-26
Countries
- China
Study Locations
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