Clinical Trials

Date: 2018-05-29

Type of information: Clinical trial authorisation

phase: 1

Announcement: clinical trial authorization

Company: Olix Pharmaceuticls (South Korea)

Product: OLX10010

Action mechanism: RNAi

Disease: hypertrophic scar

Therapeutic area: Dermatological diseases

Country: UK

Trial details:

The aims of this Study are to determine the safety of the Study Drug and any side effects that might be associated with it, and how much of the Study Drug gets into the bloodstream and how long it takes the body to remove it.
As the selection criteria for the subjects, the healthy adult subjects can participate in this study in the age between 18 and 60 years old in the UK. Both female and male subjects can participate in this study.
This study will be conducted in 2 parts, Part A and B. Part A will be a single subcutaneous dose (Groups A1 to A4) or intradermal dose (Groups A5 to A8), dummy controlled study. Overall, 32 subjects will be studied in 8 groups; 4 groups (Groups A1 to A4) of 4 subjects to assess OLX10010 administered subcutaneously and 4 groups (Groups A5 to A8) of 4 subjects to assess OLX10010 administered intradermally.
Part B will be a multiple intradermal dose, dummy controlled study. Overall, 12 subjects will be studied as 3 groups (Groups B1 to B3) with each group consisting of 4 subjects. In each group, 3 subjects will receive OLX10010 and 1 subject will receive placebo. (NCT03569267)

Latest news:

• On May 29, 2018, OliX Pharmaceuticals, a developer of RNA interference (RNAi) therapeutics, announced that it received the Phase I clinical trial authorization (CTA) with its anti-scar drug, OLX10010, from Medicines and Healthcare products Regulatory Agency (MHRA) in the UK as of May 11, 2018.
Phase I study of OLX10010 in Korea was conducted by Hugel Inc., OliX's co-developer and exclusive distributor in Asia, and completed without any serious adverse events. Covance, a global contract research organization and drug development services company, will conduct the Phase I trial in their specialized clinic, which is expected to be finished by the first half of 2019.