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A Phase 1 Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of SA001 in Healthy Male Volunteers

NCT02470286 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-03-24

No results posted yet for this study

Summary

The purpose of this phase1 study is to investigate the pharmacokinetics, safety and tolerability of a single oral dose of SA001 and its active metabolite in healthy male volunteers.

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)

Sponsors & Collaborators

  • Samjin Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kyung-sang Yu, M.D., Ph.D., M.B.A · Seoul National University College of Medicine / Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-29
Primary Completion
2015-09-18
Completion
2015-09-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02470286 on ClinicalTrials.gov