NCT03610880

To Evaluate PK and Safety Profile of Oral MAD of Separately Using TG-2349, DAG181 or Combination in Healthy Chinese Volunteers

A Single Center, Randomized, Open-label, Two-arm, Parallel Design Study to Evaluate PK and Safety Profile of Multiple Ascending Oral Doses of Separately Using TG-2349 or DAG181 or TG-2349 Plus DAG181 in Healthy Chinese Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To evaluate the drug-drug reactions between TG-2349 and DAG181, and the pharmacokinetics and tolerability profile in healthy Chinese volunteers to be the reference for protocol designs of subsequent clinical trials.

Detailed description

This is a single center, randomized, open-label, two-arm, parallel design, phase I study that using TG-2349 or DAG181 alone, or TG-2349 plus DAG181 to evaluate the drug-drug reactions, the pharmacokinetics, and tolerability profile in healthy Chinese volunteers. The results will be the reference for protocol designs of subsequent clinical trials.

Conditions

• Healthy Chinese Volunteers

Interventions

Type	Name	Description
DRUG	TG-2349 (400 mg) plus DAG181 (200 mg)	Dosing period 1 (Day 1 to 7): TG-2349 400 mg； Dosing period 2 (Day 8 to 14): TG-2349 400 mg + DAG181 200 mg
DRUG	DAG181 (200 mg) plus TG-2349 (400 mg)	Dosing period 1 (Day 1 to 7): DAG181 200 mg； Dosing period 2 (Day 8 to 14): TG-2349 400 mg + DAG181 200 mg

Timeline

• Start date: 2017-10-17
• Primary completion: 2018-02-05
• Completion: 2018-02-05
• First posted: 2018-08-01
• Last updated: 2018-08-01

Locations

1 site across 1 country: China