NCT04164290

A Study to Evaluate the Tolerability and Pharmacokinetics of Jiashen Tablets in Healthy Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of Jiashen Tablets in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Tasly Pharmaceutical Group Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Jiashen Tablets as an oral, compound traditional chinese medicine prepatations, have an effect on improvement of the heart failure. This study will assess the safety, tolerability and pharmacokinetics (PK) of Jiashen Tablets, following oral administration of single and multiple ascending dose of Jiashen Tablets.

Detailed description

This study will include a randomized, double-blind, placebo-controlled, single ascending dose design study (Part A), and an open-label SDAD pre-multiple daily ascending dose (MDAD) study (Part B) and an open-label MDAD study (Part C) study. The study will be conducted in healthy participants and performed at a single study center. 70 healthy participants are planned to be included in the study. Part A will include six cohorts, 40 participants. Within each cohort, 2 participants will be randomized to receive placebo and other participants randomized to receive Jiashen Tablets. Each participant will receive Jiashen Tablets at the selected dose level or placebo by oral administration in a fasted state once daily. Part B will include two cohorts, 6 participants, minimum dose group and maximum dose group respectively depending on the findings. Within each cohort, participant will receive Jiashen Tablets at the selected dose level by oral administration in a fasted state once daily. Part C will include three cohorts, 24 participants. Within each cohort, participant will receive Jiashen Tablets at the selected dose level by oral administration in a fasted state once daily for 7 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Jiashen Tablets	1 tablet
DRUG	Jiashen Tablets	2 tablets
DRUG	Jiashen Tablets	4 tablets
DRUG	Jiashen Tablets	6 tablets
DRUG	Jiashen Tablets	8 tablets
DRUG	Jiashen Tablets	9 tablets
DRUG	Jiashen Tablets Placebo	1 tablet
DRUG	Jiashen Tablets Placebo	2 tablets
DRUG	Jiashen Tablets Placebo	4 tablets
DRUG	Jiashen Tablets Placebo	6 tablets
DRUG	Jiashen Tablets Placebo	8 tablets
DRUG	Jiashen Tablets Placebo	9 tablets

Timeline

• Start date: 2020-06-29
• Primary completion: 2021-04-09
• Completion: 2021-04-09
• First posted: 2019-11-15
• Last updated: 2022-11-23

Locations

1 site across 1 country: China