Paid clinical trial for healthy males and females aged 18-45
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The main aim of this study is to determine, how safe the drug is, how much of the drug enters the blood stream and how long it remains in the body when given by an injection just under the skin or given directly into the vein. The results of this study will help us to plan for future clinical trials in patients with disorders of the immune system.
The drug is being developed as a treatment of rare diseases caused by abnormalities in the immune system. Currently, the treatment for some of these diseases is given directly into the vein which usually requires patients to go to a hospital.
In this study we look to see if an injection under the skin can be developed to potentially allow patients to take their medication themselves at home meaning they can reduce their trips to hospital.Register your interest in this clinical trial
This study will be conducted at our clinical trials unit in London Bridge and will involve healthy volunteers.
To take part in the study;
- You will need to attend a screening appointment within 70 days of being dosed.
- If you have not been vaccinated against meningitis in the last 2 years and 6 months you will be required to attend two additional screening appointments to receive the vaccination.
- If you pass screening and are invited to take part in the study, you will be required to be in our unit for an in-house stay of 6 days/5 nights and attend a number of out-patient visits after receiving the last dose.
Who can take part?
To be eligible to take part in this project you must fit the following criteria:
- Healthy male and female volunteers aged between 18 and 45 (inclusive).
- You must have a Body Mass Index (BMI) within the range 18-29.9 kg/m² (inclusive).
- You must have a body weight of between 50-90 kg.
- You must be a non-smoker.
- You must not test positive for hepatitis B/C, HIV, alcohol or drugs or show any evidence of drug or alcohol abuse. (Alcohol abuse is defined as a regular weekly intake of more than 14 units).
- You must not have been immunised with a live-attenuated vaccine 28 days prior to the first study drug administration or plan to be vaccinated during the course of this study (except for vaccination planned in this study).
- You must be healthy with no underlying medical conditions that may either interfere with participation in the clinical study, and/or put you at any significant risk.
- You must not be on any regular medications, including over the counter medications.
- You must not have donated or lost blood within 16 weeks prior to first dosing.
- You must not be pregnant or breastfeeding.
- Female volunteers of childbearing potential, if heterosexually active, must agree to the use of highly effective contraception starting during the screening period and continuing for at least 6 months after study drug administration or must abstain from heterosexual intercourse.
- You must agree not to donate sperm or ova (eggs) 6 months after study drug administration.
A full list of acceptable contraceptive methods will be discussed in full by a member of the recruitment team and a study doctor during screening.
In recognition of the time and effort involved in taking part in this study, you will receive £5,380 (£4,380 study payment and £1,000 bonus) on completion of the study provided you comply fully with all the study requirements. This amount is based on the expected time you spend with us during this study.
Contact our volunteer recruitment team
Call our team weekdays between 09h00 and 17h00 for more information: +44 (0) 20 7042 5800 (opt 1)
Or email us: firstname.lastname@example.orgRegister your interest in this clinical trial
Ref: ALXN1720_C18053_Study Advertising email_website text
The contents of this page have been approved by an ethics committee. Any response to this advertisement will be recorded. Your response will not place you under any obligation to participate in this trial.
You may be required to remain resident in the unit until resolution of any safety issues, after which you will be discharged from the unit.