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Evaluate the Pharmacokinetics, Safety and Tolerability of JT001 Tablets

NCT05355077 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-02-09

No results posted yet for this study

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.

Conditions

  • Healthy Subjects

Interventions

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

Sponsors & Collaborators

  • Shanghai Vinnerna Biosciences Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Juan Ma, Master · Shanghai Junshi Bioscience Co., Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-02
Primary Completion
2022-08-01
Completion
2022-10-24

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05355077 on ClinicalTrials.gov