Study of WPV01 in Healthy Subjects

Westlake Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: WPV01 Dose 13-15 and Ritonavir; Drug: WPV01 Dose 9-12; Drug: WPV01 Dose 5-8 and Ritonavir; Drug: WPV01 Dose 16; Drug: WPV01 Dose 1-4

Study type: Interventional

Funder types: Industry

Identifiers

NCT06205329

WPV01-CP-01

Details and patient eligibility

About

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

Enrollment: 108 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 5 patient groups

WPV01 Dose 1-4

Experimental group

Description:

WPV01 Dose 1-4 or Placebo

Treatment:

Drug: WPV01 Dose 1-4

WPV01 Dose 5-8

Experimental group

Description:

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

Treatment:

Drug: WPV01 Dose 5-8 and Ritonavir

WPV01 Dose 9-12

Experimental group

Description:

WPV01 Dose 9-12 or Placebo

Treatment:

Drug: WPV01 Dose 9-12

WPV01 Dose 13-15

Experimental group

Description:

WPV01 Dose 13-15 or Placebo

Treatment:

Drug: WPV01 Dose 13-15 and Ritonavir

WPV01 Dose 16

Experimental group

Description:

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

Treatment:

Drug: WPV01 Dose 16