NCT05303961 - Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of SA001 in Healthy Male Volunteers | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 7, 2016

Primary Completion Date

November 11, 2016

Study Completion Date

November 11, 2016

Conditions

Healthy

Interventions

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)

All Listed Sponsors

lead

Samjin Pharmaceutical Co., Ltd.

INDUSTRY