DISCOVER A NEW WAY TO HELP
If you are a healthy male or female aged 18-65,you may be eligible to participate in a study investigating a new drug being developed for the potential treatment of Alpha-1 Antitrypsin Deficiency (AATD).
Study Payment £3975
Plus travel expenses
CLINICAL TRIAL information
Simbec-Orion Clinical Pharmacology will soon be running a two part study to investigate a drug called WVE-006.
The overall objectives of this study are to determine the safety, tolerability and concentration in the blood and urine of WVE-006 when administered in different conditions i.e., single versus multiple doses and evaluating different dose strengths.
Blood and urine samples will be taken at set timepoints throughout each period of the study in order to measure the levels of WVE-006 in the blood and urine.
The results from each of the dosing groups and each study period will be analysed in order to understand how WVE-006 works in the body (including impact from single and multiple doses, and different dose strengths).
WVE-006 is being developed as a potential treatment for a condition called Alpha-1 Antitrypsin Deficiency (AATD), which is a rare genetic condition that causes diseases impacting the liver and lungs.
Currently, there are limited treatments available for this
condition and the majority of current treatments are intended to target the symptoms and diseases which arise as a result of the condition and therefore, there is an unmet need to develop more effective treatments that seek to target the underlying cause of AATD
This study will be split into two separate periods (Period 1 & Period 2), and you will only participate in one period of the study.
The purpose of Period 1 is to evaluate WVE-006 when is administered as a single dose at increasing dose strengths.
Period 1 will consist of up to 5 planned groups of up to 8 participants: each group will evaluate a different dose of WVE-006 starting at the lowest dose and gradually increasing the dose level in each group.
Each group will include 2 participants that will be given the study drug or placebo approximately 48 hours before the rest of the participants; one will get the study drug and the other will get the placebo. These 2 participants are called “sentinels”. This is known as a single ascending dose (SAD) study.
Each group will either receive WVE-006 or a placebo (which contains no active drug) in the form of subcutaneous injection(s) which is a type of injection(s) into the tissue layer between the skin and muscle.
If you participate in this period of the study, you will be required to stay at the Simbec-Orion clinical unit for 4 days (3 overnight stays – Day -1 to Day 3) for the in-house stay, followed by 12 return visits (Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 & 85 – dates below).
You should therefore ensure that you are able to commit to
completing all visits before agreeing to participate in this study.
If you complete this period of the study, you will receive a maximum inconvenience payment of £3975.
CLINICAL TRIAL timeline
Screening for Cohort 2A opens on 26th January 2024 (subject to change).
Residential in-house stay:
Day -1: Into Simbec: 12th February
Day 3: Leave Simbec: 15th February
You should ensure that you are able to commit to the 3 overnight stays required, as these dates are not flexible.
Day 8: 20th February
Day 15: 26th February *
Day 22: 4th March
Day 29: 11th March *
Day 36: 18th March
Day 43: 25th March
Day 50: 1st April
Day 57: 8th April *
Day 64: 15th April
Day 71: 22nd April
Day 78: 29th April
Post Study Visit: 6th May*
If you fully complete this study, you will receive a maximum inconvenience payment of £3975. The payment will be split into 4 parts; £1000 after completion of the Day 15 visit, £800 after completion of the Day 29 visit, £800 after completion of the Day 57 visit, the remaining £1375 after completion of the end of study visit (Day 85).
These payment dates have been highlighted in the above dates with an asterisk (*).
Additionally, we cover travel expenses of up to £50 per round journey.
Thank you for your time to register your interest in this trial please complete the below form.
OR to speak to a member of the Enrolment Team for more information or regarding any questions or queries please ring 0800 691995 and please select option 1. Alternatively drop us an email: email@example.com