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The Safety, Tolerability, Pharmacokinetics and Food Effects of SHEN211 Tablet in Healthy Subjects

NCT06214858 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2024-01-22

No results posted yet for this study

Summary

This is a study to evaluate the safety, tolerability, pharmacokinetics, and food effects of SHEN211 tablet in healthy subjects after fasting single or multiple oral administration

Conditions

  • Phase 1

Interventions

DRUG

SHEN211 tablets

SHEN211 tablets, tablets, specification: 0.11g, 10 tablets/box, storage: sealed, not more than 25℃ storage.

DRUG

SHEN211 placebo tablets

placebo tablets, tablets, specification: 0g, 10 tablets/box, storage: sealed, not more than 25℃ storage.

Sponsors & Collaborators

  • JKT Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • wei zhao, ph.D · University of Paris 5 - Rene Descartes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-12-14
Primary Completion
2024-04-02
Completion
2024-04-30

Countries

  • China

Study Locations

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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 NCT06214858 on ClinicalTrials.gov