A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of TNP-2198 Capsules After Single Oral Dose in Healthy Participants

Phase 1 Completed 78 enrolled TenNor Therapeutics Inc.

RandomizedSequentialDouble-blindTreatment

Summary

This was a single-center, randomized, double-blind, placebo-controlled phase 1 study to evaluate the safety, tolerability, pharmacokinetics of single ascending dose and the food effect on the pharmacokinetics of TNP-2198 capsules after single dose oral administration in healthy subjects.

Timeline

Start: 2019-05-09
Primary completion: 2019-09-18
Completion: 2019-09-18

Publications

Li X, Liu Y, Wang M, Gao L, Liu J, Zhang H, Wu M, Chen H, Lou J, Wang J, Chen J, Geng G, Ma Z, Ding Y. Safety, pharmacokinetics, and efficacy of rifasutenizol, a novel dual-targeted antibacterial agent in healthy participants and patients in China with Helicobacter pylori infection: four randomised clinical trials. Lancet Infect Dis. 2024 Jun;24(6):650-664. doi: 10.1016/S1473-3099(24)00003-3. Epub 2024 Feb 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rifasutenizol	Small molecule	50 mg	Oral
Subject	Rifasutenizol	Small molecule	100 mg	Oral
Subject	Rifasutenizol	Small molecule	200 mg	Oral
Subject	Rifasutenizol	Small molecule	400 mg	Oral
Subject	Rifasutenizol	Small molecule	600 mg	Oral
Subject	Rifasutenizol	Small molecule	800 mg	Oral
Subject	Rifasutenizol	Small molecule	1000 mg	Oral

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of TNP-2198 Capsules After Single Oral Dose in Healthy Participants

Summary

Timeline

Publications

Drugs

Indications