A Phase I, SAD MAD Study of OLX10010 in Healthy Subjects
Research type
Research Study
Full title
OLX10010 ‑ A Phase I, Double‑blind, Placebo‑controlled, Single Subcutaneous and Single and Multiple Intradermal Dose, Safety, Tolerability, and Pharmacokinetic Study in Healthy Subjects
IRAS ID
227186
Contact name
Jim Bush
Contact email
Sponsor organisation
OliX Pharmaceuticals, Inc.
Eudract number
2017-001675-23
Clinicaltrials.gov Identifier
17/NE/0125, REC
Duration of Study in the UK
0 years, 8 months, 16 days
Research summary
OLX10010 is a cell penetrating asymmetric siRNA (cp asiRNA) which interferes with the expression of connective tissue growth factor (CTGF). OLX10010, with complementary nucleotide sequences, degrades CTGF mRNA after transcription preventing translation. CTGF is a key factor in the formation of hypertrophic scars and OLX10010 is being developed for the prevention and treatment of hypertrophic scars.
This will be a double blind, placebo controlled, single and multiple dose study conducted in 2 parts.
Part A will be a single dose, sequential group study. 32 subjects will be studied as 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 at different dose volumes at either 2 or 4 injection sites. In each of Groups A1 to A8, 3 subjects will receive OLX10010 and 1 subject will receive placebo.
Each subject will participate in 1 treatment period only and reside at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 3 (48 hours postdose). All subjects will return for a poststudy visit at 5 to 7 days postdose.
Part B will be a multiple intradermal dose, sequential group 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.
Each subject will be given 3 dose administrations of OLX10010 or placebo at 2 week intervals. Subjects will reside at the CRU from Day -1, Day 14, and Day 28 (the day before dosing) until Day 3, Day 17, and Day 31 (48 hours postdose). All subjects will return for a poststudy visit at 5 to 7 days after their final dose.
REC name
North East - York Research Ethics Committee
REC reference
17/NE/0125
Date of REC Opinion
8 Mar 2018
REC opinion
Further Information Favourable Opinion