Recruiting Healthy Adults
Clinical trial summary
We are conducting a clinical trial in healthy participants for an investigational drug that could be used to treat thrombosis (harmful blood clots in blood vessels).
The clinical trial involves having an injection(s) under the skin in your abdomen. Following dosing, there will be several assessments that will help us determine how safe and well-tolerated the drug is, how long the drug stays in your body, and how the drug affects your body.
You may receive a single injection or two injections depending on the cohort (group) you are assigned to. The number of required visits to the research unit and duration of the trial will vary depending on the number of injections you receive during the trial.You will be paid for your time if you take part in this clinical trial.
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 perform several assessments, including but not limited to taking blood, checking your heart function, and carrying out a physical examination.
- If results from your screening appointment show you are suitable for the trial, you will be invited to take part.
- There will be an in-house stay of approximately 3 days / 2 nights in our clinical research unit. During your stay, you will receive a single injection under the skin in your abdomen and be closely observed by medically qualified staff. We will also conduct a number of assessments (like those we did at screening) to check how safe and tolerable the trial drug is, how long the drug remains in your body and how affects your body.
- After your stay with us, you will be required to return for further 20 follow-up visits.
- This means the whole process takes approximately 14 months from your screening visit through to your final visit. In total, you will have to attend the unit on approximately 22 occasions.
Cohorts with Two Doses
- 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 perform several assessments, including but not limited to taking blood, checking your heart function, and carrying out a physical examination.
- If results from your screening appointment show you are suitable for the trial, you will be invited to take part.
- There will be two in-house stays, each lasting approximately 3 days / 2 nights in our clinical research unit. During each stay, you will receive a single injection under the skin in your abdomen and be closely observed by medically qualified staff. We will also conduct a number of assessments (like those we did at screening) to check how safe and tolerable the trial drug is, how long the drug remains in your body and how it affects your body.
- The exact timing of the second dose has been determined yet, therefore, the number of follow-up visits and the overall duration of the trial could differ depending on when the second dose is given. For e.g., the additional follow-up visits could range from 27 visits to 30 visits, and the overall duration could range from approximately 16 months to 19 months from your screening visits to your final visit. This means that you will have to attend the unit on approximately 30 to 33 occasions.
Who can take part?
We will check your suitability for the clinical trial using the following criteria:
- You are a male or female of non-childbearing potential aged between 18 and 45 years old.
- You weigh over 50kg and have a BMI between 18 and 25 kg/m2, inclusive, at screening.
- You must be healthy with no underlying medical conditions that may affect the trial or put you at significant risk.
- You must not have a known history of serious allergic reactions.
- You must not have had any major surgery or significant traumatic injury within 3 months before dosing.
- You must not have participated in a clinical trial with an investigational drug within the last 90 days before dosing.
- Male participants with female partners of childbearing potential must be willing to use appropriate barrier contraception for the duration of the trial.
Please note there are additional study criteria. 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.
Duration of Stay
Clinical trial payment
In recognition of the time involved in taking part in the trial, you will recieve £5,200 (£3,400 clinical trial payment and £1,800 compliance 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.
Location
Dates
Please call a recruitment team member on 02070425800 to discuss study dates, or register to receive a call back.
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: C25006_May-2025 (email_website_advert text)
Speak to a member of our Volunteer Recruitment Team
Comments from volunteers
Thanks very much to the Volunteer Recruitment Team. I am so excited to be part of this trial. I can’t thank you and your colleagues enough for all your help, professionalism, and kindness.
Steve K
Unbelievable service! They looked after me so well, and I would recommend them to anyone interested in participating in a clinical trial. I want to thank all the staff at trials4us for their continued efforts and for looking after me so well.
Chas
Very impressive. Thank you for taking care of me and for the valuable service you offer.
Joann
Very professional environment in the heart of London to conduct studies that help discover the medicines of the future.
James
Recruiting people with type 2 diabetes
Study Summary
In this study, we are recruiting participants with Alpha 1 (with a known or suspected PiZZ mutation) aged 18 to 70. We will give you a tour of the clinical trials unit and conduct a number of clinical assessments to establish your current health status.
This study is to help participants with Alpha 1 decide if they want to participate in future gene editing clinical trials.
If you are interested in participating in this patient engagement study
- You will need to attend an in-person visit, we will give you a tour of the clinical trial unit and perform tests to check your general health to obtain a clinical baseline.
- The tests can be spread over multiple days (if required).
- You will have a follow-up call with a doctor a week after the in-person visit.
- This means the whole process takes approximately 1 week.
Who can take part?
- You are aged between 18 to 70 years (inclusive).
- You must have been diagnosed with alpha-1 antitrypsin deficiency (Alpha 1) (with a known or suspected PiZZ mutation).
- You must be able and willing to provide informed consent.
- You must be willing and able to comply with study assessments.
Study payment
Study dates
Approval
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: C23017_MAR_2024 (email_website_advert text)