Study of WPV01 in Healthy Subjects

Phase 1CompletedNCT06205329

Westlake Pharmaceuticals (Hangzhou) Co., Ltd.108 enrolled

Overview

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WPV01 and WPV01 Co-administrated With Ritonavir in Healthy Adult Subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

108

Conditions

Healthy Participants

Interventions

WPV01 Dose 1-4DRUG

WPV01 Dose 1-4 or Placebo on day 1

WPV01 Dose 5-8 and RitonavirDRUG

WPV01 Dose 5-8 and Ritonavir or Placebo on day 1

WPV01 Dose 9-12DRUG

WPV01 Dose 9-12 or Placebo from day 1 to day 6

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Shulan(Hangzhou) Hospital

Hangzhou, China

Outcomes

Primary Outcomes

To evaluate the safety and tolerability of single and multiple oral doses of WPV01 and WPV01 in combination with ritonavir in healthy subjects.

Adverse events, including type, incidence, grade (determined with reference to NCI-CTCAE V5.0)

Time frame: Day 1 to Day 18

Secondary Outcomes

Maximum Plasma Concentration (Cmax) in Single Ascending Dose (SAD)

The maximum observed plasma concentration (Cmax) is estimated based on the plasma concentrations

Time frame: SAD part: Day 1 to Day 18

Time for Cmax (Tmax) in SAD

Tmax was summarized by dosing regimen. It was observed directly from data as time of first occurrence.

Time frame: SAD part: Day 1 to Day 18

Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) in SAD

AUClast is summarized by dosing regimen and determined by linear/log trapezoidal method.

Time frame: SAD part: Day 1 to Day 18

Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) in SAD

AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).

Time frame: SAD part: Day 1 to Day 18

Terminal Elimination Half-Life (t½) in SAD

t1/2 is summarized by dosing regimen . It is determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline is used in the regression.

Data from ClinicalTrials.gov

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