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Healthy ParticipantsPhase 1NCT06205329

Study of WPV01 in Healthy Subjects

A Phase 1 study testing WPV01 Dose 1-4, WPV01 Dose 5-8 and Ritonavir and WPV01 Dose 9-12 in people with Healthy Participants, run by Westlake Pharmaceuticals (Hangzhou) Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
WPV01 Dose 1-4, WPV01 Dose 5-8 and Ritonavir and WPV01 Dose 9-12
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteChina
Study dates
3 Oct 2022to 26 Jul 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shulan(Hangzhou) Hospital

    Hangzhou

Other trials in China

About this study

Official title: Phase I Study on the Safety, Tolerability, Pharmacokinetics, and Food Effect Evaluation of WPV01 and WPV01 Co-administrated Ritonavir in Healthy Subjects

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

Being tested
WPV01 Dose 1-4, WPV01 Dose 5-8 and Ritonavir, WPV01 Dose 9-12, WPV01 Dose 13-15 and Ritonavir, WPV01 Dose 16

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • WPV01 Dose 13-15 and RitonavirDrug

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

  • WPV01 Dose 16Drug

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

Study groups in NCT06205329
Study groupRoleWhat they receive
WPV01 Dose 1-4ExperimentalWPV01 Dose 1-4 or Placebo
Receives: Drug: WPV01 Dose 1-4
WPV01 Dose 5-8ExperimentalWPV01 Dose 5-8 co-administrated with ritonavir or Placebo
Receives: Drug: WPV01 Dose 5-8 and Ritonavir
WPV01 Dose 9-12ExperimentalWPV01 Dose 9-12 or Placebo
Receives: Drug: WPV01 Dose 9-12
WPV01 Dose 13-15ExperimentalWPV01 Dose 13-15 or Placebo
Receives: Drug: WPV01 Dose 13-15 and Ritonavir
WPV01 Dose 16ExperimentalWPV01 Dose 16(with high fat meal) or WPV01 Dose 16 (fed)
Receives: Drug: WPV01 Dose 16

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Day 1 to Day 18

Secondary outcomes (14)

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

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

    Measured: SAD part: Day 1 to Day 18

  2. Time for Cmax (Tmax) in SAD

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

    Measured: SAD part: Day 1 to Day 18

  3. 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.

    Measured: SAD part: Day 1 to Day 18

  4. 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).

    Measured: SAD part: Day 1 to Day 18

  5. 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.

    Measured: SAD part: Day 1 to Day 18

  6. Apparent Clearance (CL/F) in SAD

    CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Calculated as Dose/AUCinf. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

    Measured: SAD part: Day 1 to Day 18

  7. Apparent Volume of Distribution (Vz/F) in SAD

    Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed.

    Measured: SAD part: Day 1 to Day 18

  8. Cmax in Multiple Ascending Dose (MAD)

    Observed Cmax is estimated based on the plasma concentrations

    Measured: MAD part: Day 1 to Day 22

  9. Time for Cmax (Tmax) in MAD

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

    Measured: MAD part: Day 1 to Day 22

  10. Area Under the Plasma Concentration-Time Profile From Time Zero To End of Dosing Interval (AUCtau) in MAD

    AUCtau is summarized by dosing regimen and period. Dosing interval is the interval tau between administration of doses of drug. In this study, the dosing interval is 8 hours for three times daily (TID) dosing and 12 hours for twice daily (BID) dosing. It is determined by linear/log trapezoidal method.

    Measured: MAD part: Day 1 to Day 22

  11. To evaluate the metabolites of single oral doses of WPV01 and WPV01 in combination with ritonavir in healthy subjects

    Urine and stool samples will be collected for metabolite analysis. The major metabolites will be identified and, if necessary, quantitatively identified.

    Measured: MAD part: Day 1 to Day 22

  12. Cmax in Food Effect (FE)

    The maximum observed plasma concentration (Cmax) is estimated based on the plasma concentrations of cohort 1 and cohort 2 in FE part.

    Measured: Day 1 to Day 22

  13. Tmax in FE

    It was observed directly from data as time of first occurrence in cohort 1 and cohort 2 of FE part.

    Measured: Day 1 to Day 22

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

    AUClast was summarized using the data in cohort 1 and cohort 2 of FE part.

    Measured: Day 1to Day 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2024
  2. Study start3 Oct 2022
  3. Primary completion11 Mar 2023
  4. Study completion26 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06205329
Sponsor's protocol ID
WPV01-CP-01
Status last verified
Jun 2024
First submitted
28 Mar 2023
Last updated
13 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 6 months after summary data has been published, sponsor will share the IPD and additional supporting information after internal approval process.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing WPV01 Dose 1-4, WPV01 Dose 5-8 and Ritonavir and WPV01 Dose 9-12 in people with Healthy Participants, run by Westlake Pharmaceuticals (Hangzhou) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the safety and tolerability of single and multiple oral doses of WPV01 and WPV01 in combination with ritonavir in healthy subjects. (time frame: Day 1 to Day 18). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06205329.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.

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