NCT02470286 - A Phase 1 Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of SA001 in Healthy Male Volunteers | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 29, 2015

Primary Completion Date

September 18, 2015

Study Completion Date

September 30, 2015

Conditions

Healthy

Interventions

DRUG

SA001 60mg or Placebo

"* Study Drug: SA001 60mg~* Comparator: Placebo~* Cohort 1 in the part 1 (Dose escalation study)"

DRUG

SA001 120mg or Placebo

"* Study Drug: SA001 120mg~* Comparator: Placebo~* Cohort 2 in the part 1 (Dose escalation study) and part 2 (Food effect study)"

DRUG

SA001 180mg or Placebo

"* Study Drug: SA001 180mg~* Comparator: Placebo~* Cohort 3 in the part 1 (Dose escalation study)"

DRUG

SA001 240mg or Placebo

"* Study Drug: SA001 240mg~* Comparator: Placebo~* Cohort 4 in the part 1 (Dose escalation study)"

DRUG

SA001 300mg or Placebo

"* Study Drug: SA001 300mg~* Comparator: Placebo~* Cohort 5 in the part 1(Dose escalation study) and part 2 (Food effect study)"

Trial Locations (1)

Seoul National University Hospital, Seoul

All Listed Sponsors

lead

Samjin Pharmaceutical Co., Ltd.

INDUSTRY