NCT05355077

Evaluate the Pharmacokinetics, Safety and Tolerability of JT001 Tablets

An Open-label, Dose-Escalation, Multiple-Dose Phase 1 Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of JT001 Tablets in Caucasian Healthy Subjects After Oral Administrations

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Shanghai Vinnerna Biosciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, open-label, dose-escalation, multiple-dose study to investigate pharmacokinetics and safety of JT001 (VV116) in Caucasian healthy subjects.

Detailed description

Subjects will be admitted to the Phase 1 clinical study ward on the day before administration (Day -1, baseline phase), and will be confined until all examinations and assessments are completed on Day 8. Subjects will be followed up on Day 12 (± 1 day); if there are abnormalities, an unscheduled visit may be arranged for subjects at the Investigators discretion. Subjects who withdraw early should be encouraged to complete the early withdrawal visit. At the Screening visit, subjects who are willing to take part in the study will sign informed consent forms (ICFs) and complete the screening examinations. Subjects who meet all of the inclusion criteria and none of the exclusion criteria will be assigned to receive the investigational product (IP) at 1 of the 3 doses according to the dose-escalation scheme, and will be followed up until the 6th day after the last administration. Time of Collection of PK Blood Samples To gather the PK data, PK blood samples will be collected at the following specified times: Day 1: pre-dose (within 1 h before the first administration), and at 10 min, 20 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, and 12 hours after the first administration. Day 5: pre-dose (within 0.5 hour before each administration) Day 6: pre-dose (within 0.5 hour before administration), and at 10 min, 20 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, and 48 hours post-dose. Dose-Escalation Scheme This study consists of 3 dosing group (200, 400, and 600 mg). A dose-escalation design is used, sequentially from the low-dose group to the high-dose group, and each subject will only receive oral administration at one dose level according to the dose-escalation scheme. All subjects will be administered orally twice a day (approximately 12 hours apart) for 6 consecutive days and the last administration will be given in the morning on Day 6. All doses must be taken under fasting conditions.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	JT001 200mg Bid	JT001 (VV116):200 mg,oral,Twice a day,6 consecutive days and the last administration will be given in the morning on Day 6
DRUG	JT001 400mg Bid	JT001 (VV116):400 mg,oral,Twice a day,6 consecutive days and the last administration will be given in the morning on Day 6
DRUG	JT001 600mg Bid	JT001 (VV116):600 mg,oral,Twice a day,6 consecutive days and the last administration will be given in the morning on Day 6

Timeline

• Start date: 2022-05-02
• Primary completion: 2022-08-01
• Completion: 2022-10-24
• First posted: 2022-05-02
• Last updated: 2023-02-09