A Phase I SAD and MAD study to investigate OLP-1002
Research type
Research Study
Full title
OLP-1002 – A First-in-Human, Double-blind, Placebo-controlled, Single and Multiple Subcutaneous Dose, Safety, Tolerability, and Pharmacodynamic Study in Healthy Male and Female Subjects
IRAS ID
248664
Contact name
Firas Almazedi
Contact email
Sponsor organisation
OliPass Corporation
Eudract number
2018-003085-13
Clinicaltrials.gov Identifier
18/LO/1205, REC Reference
Duration of Study in the UK
0 years, 10 months, 28 days
Research summary
OLP-1002 (Study Drug) is being tested as a potential treatment for pain.
This study will be conducted in two parts to assess single and multiple ascending doses in healthy male and female subjects.
In Part A subjects will receive one subcutaneous (injection under the skin) dose. Each subject will participate in 1 period only, and stay overnight from Day -2 to 3. All subjects will return for non-residential visits on Days 4, 7, 10 and 14 and a follow-up. Five groups (A1, A3, A5, A7, and A8) will comprise 4 subjects (3 active: 1 placebo). To assess whether OLP-1002 has any effect on pain, 3 groups (PD Assessment Groups A2, A4, and A6) will consist of 8 subjects (6 active: 2 placebo).
Sentinel dosing (where safety data is reviewed prior to dosing the remaining subjects) will be employed for all groups in Part A. To maintain the blind in a 4 subject group, the 1st subject will be dosed 48 hours before the 2nd, and the 2nd subject will be dosed 48 hours before the 3rd and 4th subjects. In PD assessment groups, 2 subjects (1 active: 1 placebo), will be dosed 48 hours before the remaining 6 subjects (5 active: 1 placebo).
In Part B subjects will receive multiple doses. A single subcutaneous dose will be administered on Days 1, 4, 7, 10, and 13. Overall, 24 subjects will be studied in 3 groups (Groups B1 to B3), with each group consisting of 8 subjects (6 active: 2 placebo). There will be no sentinel dosing in Part B. Each subject will participate in 1 treatment period only and stay overnight from Day -1 until Day 15. All subjects will return for non-residential visits on Days 18, 22, 25 and 29, and a follow-up.REC name
London - Brent Research Ethics Committee
REC reference
18/LO/1205
Date of REC Opinion
16 Nov 2018
REC opinion
Further Information Favourable Opinion