A Dose Block-randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation, Phase I Clinical Study
Phase of Trial: Phase I
Latest Information Update: 11 Dec 2017
At a glance
- Drugs KL 1333 (Primary)
- Indications MELAS syndrome; Mitochondrial disorders
- Focus Adverse reactions; First in man
- Sponsors KT&G Life Sciences; Yungjin Pharm Co
- 11 Dec 2017 According to a NeuroVive Pharmaceutical media release, remaining higher dose-cohorts have now been approved by the Korean medicinal authority, the Ministry of Food and Drug Safety (MFDS).
- 27 Jun 2017 Planned number of patients changed from 10 to 60, according to a NeuroVive Pharmaceutical media release.
- 27 Jun 2017 According to a NeuroVive Pharmaceutical media release, first healthy volunteer has been enrolled in the study. The principal investigator for the study is Professor Kyung-Sang Yu MD, PhD at the Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine.