NeuroVive Pharmaceutical AB and Yungjin Pharm Corporation Ltd. announced that the last visit of the last healthy volunteer in the clinical phase I single ascending dose (SAD) study of KL1333 has been completed. All planned dosing cohorts have now been completed and no serious adverse events have occurred. The next multiple ascending dose (MAD) study run by NeuroVive will be initiated in the second half of 2018.

The study is a double-blind, placebo-controlled, single-dose, dose-escalation phase I clinical study to investigate the pharmacokinetics and safety/tolerability of KL1333 in 60 healthy subjects. All planned dosing cohorts have now been completed according to plan. Data processing is ongoing and full safety/tolerability and pharmacokinetic results are expected to be available in mid-2018.

The results of Yungjin's SAD study will be referenced for the final design of NeuroVive's upcoming multiple ascending dose (MAD) study in healthy volunteers and patients with genetic mitochondrial disease. NeuroVive has chosen a global contract research organization (CRO), for its planned repeated dosage phase I study of KL1333 in healthy volunteers and genetic mitochondrial disease patients. The study is expected to commence in the second half of 2018.

The MAD study will consist of two parts; a dose escalation in healthy volunteers, and also dosing of patients with genetic mitochondrial disease. The purpose of the study is to investigate safety and pharmacokinetics of KL1333. The study will be conducted at sites in the UK and results are expected in the first half of 2019.