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
- 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.