A block-randomized, double-blind, placebo-controlled, single-dose, dose-escalation, Phase I clinical study to investigate the pharmacokinetics and safety/tolerability of SA001 in healthy male volunteers

Trial Profile

A block-randomized, double-blind, placebo-controlled, single-dose, dose-escalation, Phase I clinical study to investigate the pharmacokinetics and safety/tolerability of SA001 in healthy male volunteers

Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 08 Mar 2017

At a glance

  • Drugs SA 001 (Primary)
  • Indications Dry eyes
  • Focus Pharmacokinetics
  • Sponsors Samjin Pharmaceutical Company
  • Most Recent Events

    • 02 Jun 2016 Planned number of patients changed from 40 to 96.
    • 02 Jun 2016 Patients are exposed to SA001 in single as well as multiple doses in Dose escalation manner (doses are not mentioned).
    • 02 Jun 2016 Planned primary completion date changed from 1 Dec 2015 to 1 Dec 2016.
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