Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
108 participants
INTERVENTIONAL
2022-10-03
2023-07-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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WPV01 Dose 1-4
WPV01 Dose 1-4 or Placebo
WPV01 Dose 1-4
WPV01 Dose 1-4 or Placebo on day 1
WPV01 Dose 5-8
WPV01 Dose 5-8 co-administrated with ritonavir or Placebo
WPV01 Dose 5-8 and Ritonavir
WPV01 Dose 5-8 and Ritonavir or Placebo on day 1
WPV01 Dose 9-12
WPV01 Dose 9-12 or Placebo
WPV01 Dose 9-12
WPV01 Dose 9-12 or Placebo from day 1 to day 6
WPV01 Dose 13-15
WPV01 Dose 13-15 or Placebo
WPV01 Dose 13-15 and Ritonavir
WPV01 Dose 13-15 and Ritonavir or Placebo from day 1 to day 6
WPV01 Dose 16
WPV01 Dose 16(with high fat meal) or WPV01 Dose 16 (fed)
WPV01 Dose 16
Cohort 1:WPV01 Dose 16 or Placebo (with high fat meal) Cohort 2:WPV01 Dose 16 or Placebo (fasted)
Interventions
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WPV01 Dose 1-4
WPV01 Dose 1-4 or Placebo on day 1
WPV01 Dose 5-8 and Ritonavir
WPV01 Dose 5-8 and Ritonavir or Placebo on day 1
WPV01 Dose 9-12
WPV01 Dose 9-12 or Placebo from day 1 to day 6
WPV01 Dose 13-15 and Ritonavir
WPV01 Dose 13-15 and Ritonavir or Placebo from day 1 to day 6
WPV01 Dose 16
Cohort 1:WPV01 Dose 16 or Placebo (with high fat meal) Cohort 2:WPV01 Dose 16 or Placebo (fasted)
Eligibility Criteria
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Inclusion Criteria
* Chinese healthy male or female subjects between aged from 18 to 45 years
* Subjects must agree to comply with the contraceptive requirements during the trial and for 3 months after the last dose
* Body weight ≥ 50 kg for men and ≥ 45 kg for women and body mass index in the range of 18.0 \~ 28.0 kg/m2 (including 18.0 and 28.0)
* Subjects must be willing to understand and comply with study procedures and limitations, have the ability to complete the trial as planned, and be able to communicate effectively with the investigator
Exclusion Criteria
* Pregnant or lactating women; Women who have pregnancy plan 1 month before trail, during trail or within 3 months after last dose; Women with positive serum pregnancy tests at screening or baseline
* Participants who have evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic disease
* Participants who have history of any other acute or chronic illness
* Participants who have known allergy to any ingredient in the study treatment drug
* Participants who are judged by the investigator to be unsuitable to participate in this study
18 Years
45 Years
ALL
Yes
Sponsors
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Westlake Pharmaceuticals (Hangzhou) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Shulan(Hangzhou) Hospital
Hangzhou, , China
Countries
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Other Identifiers
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WPV01-CP-01
Identifier Type: -
Identifier Source: org_study_id
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