NCT04667013

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

A Bridged Phase 1, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of TBN in Healthy Subjects

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Guangzhou Magpie Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

The trial is a single center, placebo-controlled, double-blind, multiple-dose study in 2 ascending dose cohorts of healthy subjects. The primary purpose of this study is to investigate the safety, tolerability and pharmacokinetic property of the multiple doses of TBN administered for 6.5 consecutive days in healthy participants.

Conditions

• Healthy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-03-31
• Completion: 2026-08-30
• First posted: 2020-12-14
• Last updated: 2025-03-19

Regulatory

• FDA-regulated drug study