NCT05303961

Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of SA001 in Healthy Male Volunteers

A Dose-block Randomized, Double-blind, Placebo/Active-controlled, Single/Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics of SA001 After Oral Administration in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Samjin Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study consists of Part 1 followed Part 2. Part 1 The purpose of this phase1 study is to investigate the pharmacokinetics, safety and tolerability of a single oral dose of SA001 and active comparator(Rebamipide) in healthy male volunteers. Part 2 The purpose of this phase1 study is to investigate the pharmacokinetics, safety and tolerability of multiple oral dose of SA001 in healthy male volunteers.

Detailed description

Part 1(Single dose, dose escalation study, SA001 240mg\~1,080mg dose group) The starting dose is SA001 240mg, and the maximum dose is 1,080mg. Each dose group is assigned to Experimental group (SA001 or SA001 + Active Comparator(Rebamipide)) or Placebo group in a ratio of 3:1. The pharmacokinetics, safety and tolerability of SA001 and its metabolite are investigated after a single oral administration. Part 2 (Multiple dose, dose escalation study, SA001 360mg\~1,080mg dose group) The starting dose is SA001 360mg, and the maximum dose is 1,080mg. Each dose group is assigned to SA001 or Placebo in a ratio of 3:1. The pharmacokinetics, safety and tolerability of SA001 and its metabolite are investigated after a multiple oral administration.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	SA001 240mg + Rebamipide 200mg or Placebo	Cohort 1 in the Part1(Single dose): Study drug(SA001 240mg + Rebamipide 200mg), Comparator: Placebo
DRUG	SA001 480mg or Placebo	Cohort 2 in the Part1(Single dose): Study drug(SA001 480mg), Comparator(Placebo)
DRUG	SA001 710mg + Rebamipide 600mg or Placebo	Cohort 3 in the Part1(Single dose): Study drug(SA001 720mg + Rebamipide 600mg), Comparator(Placebo)
DRUG	SA001 1,080mg or Placebo	Cohort 4 in the Part1(Single dose): Study drug(SA001 1,080mg), Comparator(Placebo)
DRUG	SA001 360mg or Placebo	Cohort 5 in the Part2(Multiple dose): Study drug(SA001 360mg), Comparator(Placebo)
DRUG	SA001 720mg or Placebo	Cohort 6 in the Part2(Multiple dose): Study drug(SA001 720mg), Comparator(Placebo)
DRUG	SA001 1,080mg or Placebo	Cohort 7 in the Part2(Multiple dose): Study drug(SA001 1,080mg), Comparator(Placebo)

Timeline

• Start date: 2016-06-07
• Primary completion: 2016-11-11
• Completion: 2016-11-11
• First posted: 2022-03-31
• Last updated: 2022-03-31