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Clinical trial summary
We are conducting a clinical trial for an investigational drug that could be used to treat people with Paroxysmal Nocturnal Hemoglobinuria (PNH). PNH is a rare, life-threatening disease that leads to the destruction of red blood cells by the body’s immune system. Patients with PNH may experience fatigue, blood clots, and other symptoms like bone marrow failure or kidney failure.
The clinical trial involves having one injection under the skin, safety assessments and repeated blood sampling to discover how your body processes the drug, how long the drug stays in your body and how the drug affects the body. In this clinical trial, we are recruiting up to 24 healthy participants aged 18 to 40.
If you are interested in participating in the trial:-
- You will need to attend a screening appointment so we can check if you are suitable to take part in the trial. At this appointment, we will take blood, check your heart, carry out a physical examination and if required you will receive vaccinations to protect you from the risk of infections.
- If results from your screening appointment show you are suitable for the trial, you will be invited to take part. You may be required to have a number of vaccines before you take part in the trial.
- This will involve an in-house stay of 3 days / 2 nights in our clinical research unit.
- After your stay with us, you will be required to return for up to 18 further appointments up to the end of the trial.
- This means the whole process takes up to approximately 14 months from your screening visit through to your final visit.
- In total, if you are included in the clinical trial, you will come to the research unit up to 20 times.
- During your stay with us you will receive a single dose of the investigational drug by injection under the skin in your abdomen. You will also receive antibiotics twice a day from Day -1 to minimise the risk of infections. The number of days you will remain on antibiotics will be determined by the research doctor based on emerging data from the study. We will conduct a number of assessments (like those we did at screening) to see how you tolerate the investigational drug, and to understand how your body processes it and how it affects the body.
Who can take part?
We will check your suitability for the clinical trial using the following criteria:-
- You are a male or female aged 18 to 40 years.
- You must weigh over 50kg and a BMI between 18 and 25 kg/m2, inclusive, at screening.
- You must be willing to have vaccinations (as required based on medical history).
- You must be willing to take antibiotics.
- You must be healthy with no underlying medical conditions that may affect the trial or put you at any significant risk.
- You must not have a history of frequent infections.
- You must not live with or provide care to people younger than 2 years of age or older than 60 years of age, or who are either immunocompromised or have other medical conditions.
- Are working or living in an environment of greater risk for meningitis and other infections (e.g., research, industrial, and clinical laboratory personnel who are routinely exposed to N. meningitidis; daycare centre workers; military personnel who are accommodated in closed quarters).
- You must not test positive for drugs of abuse or alcohol at screening or Day -1 or show any evidence of alcohol or drug abuse within 2 years of dosing on Day 1.
- You must not use prescription (excluding oral contraceptives) or over-the-counter medications (including herbal remedies and supplements) within 7 days of Day 1.
- You must not have had a vaccine (except those required for the trial) within 7 days of Day 1.
- You must not have donated plasma within 7 days of Day 1 or donated/lost more than 400ml of blood within 90 days of Day 1.
- You must not use tobacco in any form (e.g., smoking or chewing) or nicotine products in any form (e.g., gum, patch, electronic cigarettes) within 7 days of screening, or test positive for nicotine at screening or Day -1.
- You must not be pregnant or breastfeeding.
- Female participants of childbearing potential, if sexually active with a male, must agree to the use of highly effective contraception for at least 1 menstrual cycle before the trial and for the duration of the trial until the end of study visit.
- Male participants must be willing to use appropriate barrier contraception for the entire duration of the trial, with female partners of child-bearing potential (including partners that are already pregnant).
A full list of do’s and don’ts will be given to you by a member of our recruitment team if you are interested and want to find out more.
Clinical trial payment
In recognition of the time involved in taking part in the trial, you will receive £4,600 (£3,067 clinical trial payment and £1,533 bonus) on completion of the clinical trial, provided you comply fully with all the clinical trial requirements. This amount is based on the anticipated clinical trial plan and will be adjusted pro-rata (i.e. same amount of money paid per unit of time), should we invite you to attend extra visits.
Clinical trial dates
Admission: 17th July
Dismissal: 19th July
Follow-up visit(s): 25th July, 1st, 8th, 15th, 29th August, 12th, 26th September, 24th October, 21st November, 19th December 2024, 16th January, 13th February, 13th March, 10th April, 8th May, 5th June, 3rd July and 17th July 2025.
Please call a member of the recruitment team on 0207 042 5800 to discuss alternative study dates.
Approval
The contents of this email 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.
Ref: C23043_APR_2024 (email_website_advert text)
