NCT06205329

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 16, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

5 months

First QC Date

March 28, 2023

Last Update Submit

June 11, 2024

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

  • 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)

    Day 1 to Day 18

Secondary Outcomes (14)

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

    SAD part: Day 1 to Day 18

  • Time for Cmax (Tmax) in SAD

    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

    SAD part: Day 1 to Day 18

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

    SAD part: Day 1 to Day 18

  • Terminal Elimination Half-Life (t½) in SAD

    SAD part: Day 1 to Day 18

  • +9 more secondary outcomes

Study Arms (5)

WPV01 Dose 1-4

EXPERIMENTAL

WPV01 Dose 1-4 or Placebo

Drug: WPV01 Dose 1-4

WPV01 Dose 5-8

EXPERIMENTAL

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

Drug: WPV01 Dose 5-8 and Ritonavir

WPV01 Dose 9-12

EXPERIMENTAL

WPV01 Dose 9-12 or Placebo

Drug: WPV01 Dose 9-12

WPV01 Dose 13-15

EXPERIMENTAL

WPV01 Dose 13-15 or Placebo

Drug: WPV01 Dose 13-15 and Ritonavir

WPV01 Dose 16

EXPERIMENTAL

WPV01 Dose 16(with high fat meal) or WPV01 Dose 16 (fed)

Drug: WPV01 Dose 16

Interventions

WPV01 Dose 1-4DRUG

WPV01 Dose 1-4 or Placebo on day 1

WPV01 Dose 1-4
WPV01 Dose 5-8 and RitonavirDRUG

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

WPV01 Dose 5-8
WPV01 Dose 9-12DRUG

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

WPV01 Dose 9-12
WPV01 Dose 13-15 and RitonavirDRUG

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

WPV01 Dose 13-15
WPV01 Dose 16DRUG

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

WPV01 Dose 16

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shulan(Hangzhou) Hospital

Hangzhou, China

Location

MeSH Terms

Interventions

Ritonavir

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2023

First Posted

January 16, 2024

Study Start

October 3, 2022

Primary Completion

March 11, 2023

Study Completion

July 26, 2023

Last Updated

June 13, 2024

Record last verified: 2024-06

Locations

CN(1)