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A Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of TBN

NCT04667013 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-03-19

No results posted yet for this study

Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics (i.e. how study drug is taken up by the body) of TBN in healthy participants.

Conditions

  • Healthy

Interventions

DRUG

Tetramethylpyrazine nitrone (TBN) tablet / Placebo

Subjects will be administered multiple oral doses of TBN or matching placebo tablets twice a day for 6 consecutive days and a last dose in the morning of Day 7.

Sponsors & Collaborators

  • Guangzhou Magpie Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • David Wyatt, VP · Syneos Health Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-03-31
Completion
2026-08-30
FDA Drug
Yes

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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 NCT04667013 on ClinicalTrials.gov