Clinical trial NCT06205329: Study of WPV01 in Healthy Subjects
Official title: Phase I Study on the Safety, Tolerability, Pharmacokinetics, and Food Effect Evaluation of WPV01 and WPV01 Co-administrated Ritonavir in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Westlake Pharmaceuticals (Hangzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-16
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Subjects signed an informed consent form with full understanding of the test content, procedure and possible adverse effects
* 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:

* Participants who have special dietary requirements and cannot abide by the provided food
* 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

Primary outcomes:
measure: To evaluate the safety and tolerability of single and multiple oral doses of WPV01 and WPV01 in combination with ritonavir in healthy subjects.
timeFrame: Day 1 to Day 18
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax) in Single Ascending Dose (SAD)
timeFrame: SAD part: Day 1 to Day 18
measure: Time for Cmax (Tmax) in SAD
timeFrame: SAD part: Day 1 to Day 18
measure: Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) in SAD
timeFrame: SAD part: Day 1 to Day 18
measure: Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) in SAD
timeFrame: SAD part: Day 1 to Day 18
measure: Terminal Elimination Half-Life (t½) in SAD
timeFrame: SAD part: Day 1 to Day 18
measure: Apparent Clearance (CL/F) in SAD
timeFrame: SAD part: Day 1 to Day 18
measure: Apparent Volume of Distribution (Vz/F) in SAD
timeFrame: SAD part: Day 1 to Day 18
measure: Cmax in Multiple Ascending Dose (MAD)
timeFrame: MAD part: Day 1 to Day 22
measure: Time for Cmax (Tmax) in MAD
timeFrame: MAD part: Day 1 to Day 22
measure: Area Under the Plasma Concentration-Time Profile From Time Zero To End of Dosing Interval (AUCtau) in MAD
timeFrame: MAD part: Day 1 to Day 22
measure: To evaluate the metabolites of single oral doses of WPV01 and WPV01 in combination with ritonavir in healthy subjects
timeFrame: MAD part: Day 1 to Day 22
measure: Cmax in Food Effect (FE)
timeFrame: Day 1 to Day 22
measure: Tmax in FE
timeFrame: Day 1 to Day 22
measure: Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) in FE
timeFrame: Day 1to Day 22
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Shulan(Hangzhou) Hospital
Study officials:
References: