NCT04453618

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of SYHA1402 in Healthy Subjects

Safety, Tolerability, Pharmacokinetics, and Food Effect of a Tablet Formulation of SYHA1402 in Healthy Subjects: A Phase-1, Single Center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A Multiple Doses Study to Evaluate the Safety, Tolerability, Pharmacokinetics (Including Food Effect) of SYHA1402 in Healthy Subjects.

Detailed description

This study consists of two parts: The objective of the food effect study (Part 1) is to investigate the effect of food on the pharmacokinetic profiles of SYHA1402 tablets under fed and fasted conditions following the oral administration of SYHA1402. The primary objective of the multiple doses study (Part 2) is to investigate safety, tolerability and Pharmacokinetics of SYHA1402 in healthy subjects following oral administration of Multiple rising doses. Secondary objectives are the exploration of pharmacokinetics (PK) following multiple oral doses.

Conditions

• Diabetic Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	FE-SYHA1402 100mg	in either a fasted state or with a meal
DRUG	SYHA1402-25mg	SYHA1402 25mg, oral tablets
DRUG	Placebo-25mg	Matching placebo tablets
DRUG	SYHA1402-50mg	SYHA1402 50mg, oral tablets
DRUG	Placebo-50mg	Matching placebo tablets
DRUG	SYHA1402-150mg	SYHA1402 150mg, oral tablets
DRUG	Placebo-150mg	Matching placebo tablets

Timeline

• Start date: 2020-08-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2020-07-01
• Last updated: 2020-07-01