Study of WPV01 in Healthy Subjects

NCT ID: NCT06205329

Last Updated: 2024-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-03

Study Completion Date

2023-07-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Participants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

WPV01 Dose 1-4

WPV01 Dose 1-4 or Placebo

Group Type EXPERIMENTAL

WPV01 Dose 1-4

Intervention Type DRUG

WPV01 Dose 1-4 or Placebo on day 1

WPV01 Dose 5-8

WPV01 Dose 5-8 co-administrated with ritonavir or Placebo

Group Type EXPERIMENTAL

WPV01 Dose 5-8 and Ritonavir

Intervention Type DRUG

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

WPV01 Dose 9-12

WPV01 Dose 9-12 or Placebo

Group Type EXPERIMENTAL

WPV01 Dose 9-12

Intervention Type DRUG

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

WPV01 Dose 13-15

WPV01 Dose 13-15 or Placebo

Group Type EXPERIMENTAL

WPV01 Dose 13-15 and Ritonavir

Intervention Type DRUG

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)

Group Type EXPERIMENTAL

WPV01 Dose 16

Intervention Type DRUG

Cohort 1:WPV01 Dose 16 or Placebo (with high fat meal) Cohort 2:WPV01 Dose 16 or Placebo (fasted)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

WPV01 Dose 1-4

WPV01 Dose 1-4 or Placebo on day 1

Intervention Type DRUG

WPV01 Dose 5-8 and Ritonavir

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

Intervention Type DRUG

WPV01 Dose 9-12

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

Intervention Type DRUG

WPV01 Dose 13-15 and Ritonavir

WPV01 Dose 13-15 and Ritonavir or Placebo from day 1 to day 6

Intervention Type DRUG

WPV01 Dose 16

Cohort 1:WPV01 Dose 16 or Placebo (with high fat meal) Cohort 2:WPV01 Dose 16 or Placebo (fasted)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Westlake Pharmaceuticals (Hangzhou) Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shulan(Hangzhou) Hospital

Hangzhou, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WPV01-CP-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.