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Tolerance, PK and PD Effects Study of TPN-672 in Chinese Healthy Volunteers

NCT03931668 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2019-12-23

No results posted yet for this study

Summary

This is a single-site, randomized, double-blind, placebo-controlled, incremental phase I clinical trial to evaluate preliminarily the tolerance, pharmacokinetics and pharmacodynamic effects of TPN672 maleate in Chinese healthy volunteers after single dose administration.

Conditions

  • PHA1A

Interventions

DRUG

TPN-672

single dose of TPN-672 maleate tablet

Sponsors & Collaborators

  • Jiangsu Kanion Pharmaceutical Co.

    collaborator OTHER

  • Shanghai Mental Health Center

    lead OTHER

Principal Investigators

  • Yifeng SHEN, MD PhD · Shanghai Mental Health Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2019-04-17
Primary Completion
2020-10-17
Completion
2020-12-17

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 NCT03931668 on ClinicalTrials.gov