NCT06205329

Study of WPV01 in Healthy Subjects

Phase I Study on the Safety, Tolerability, Pharmacokinetics, and Food Effect Evaluation of WPV01 and WPV01 Co-administrated Ritonavir in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Westlake Pharmaceuticals (Hangzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2022-10-03
• Primary completion: 2023-03-11
• Completion: 2023-07-26
• First posted: 2024-01-16
• Last updated: 2024-06-13

Locations

1 site across 1 country: China