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About this study
We are conducting a clinical trial for a new investigational drug that could be used to treat people with alpha-1 antitrypsin deficiency (AATD) with PiZZ genotype. The drug is considered ‘investigational’ as it is not yet approved by any public health authority for any kind of treatment.
- The clinical trial involves having a single dose or multiple doses of the investigational drug as an injection under the skin in your abdomen, thigh or arm.
- The trial will help us to determine how safe and tolerable the drug is, how long the drug stays in the body, and how the drug affects the body.
- You will be reimbursed for your time if you take part in this clinical trial.
What taking part in this study involves
- You will need to attend a screening appointment at our clinical research unit 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.
The trial will involve:
- A treatment period, where you will attend the clinical research unit on 6 occasions to receive the investigation drug. You will initially receive 3 doses every 2 weeks and then 3 additional doses every 4 weeks. The investigational drug will be given as injection(s) under the skin in your abdomen, thigh or arm. After each dose, you will be closely monitored for safety and undergo several assessments (like those at screening) conducted to check how safe and tolerable the drug is, how long the drug remains in your body, and how the drug affects your body.
- During the treatment period you will be required to attend the clinical research unit on 6 additional occasions. For these visits you will not receive the investigational drug, but you will undergo safety assessments and procedures.
- After the treatment period is completed, you will be required to return for 6 follow-up visits.
Participation will last up to approximately 75 weeks, with approximately 19 - 21 visits to the clinical research unit. Additional visits, including screening visits, may be required, and your participation in the trial may be longer depending on how your body responds to the investigational drug.
Who can take part?
We will check your suitability for the trial using the following criteria:
- You are aged over 18 and less than 75 years old
- You weigh between 45-110 kg and your BMI is between 18-33 kg/m2
- You must have been diagnosed with alpha-1 antitrypsin deficiency (AATD) and have the PiZZ genotype.
- Are a non-smoker, including vaping, for a least 6 months prior to screening.
- You must not have received AAT therapy within 30 days prior to screening.
- You must not have had a respiratory tract infection that required treatment within 8 weeks prior to dosing.
- You must not test positive for drugs of abuse at screening or have a history of alcohol or drug abuse within the 3 months prior to screening.
- You must not test positive for COVID-19 and/or influenza.
- You must not test positive for Hepatitis B and C, and HIV.
- You must not be pregnant or breastfeeding or planning to become pregnant.
- Female participants of childbearing potential must be willing to use a highly effective method of contraception from screening and until the end-of study visit is completed.
- Male participants with female partners of childbearing potential must be willing to use barrier contraception (male condom) from screening and until the end-of-study visit is completed
A member of our recruitment team will give you a full list of do’s and don’ts if you are interested.
Payment information
You will be paid £8,750 on completion of the clinical trial, provided that you comply fully with all the requirements. If we invite you to attend extra visits, this amount will be adjusted pro-rata.
Approval
The contents of this webpage have been approved by an Ethics Committee. Any response to this advertisement will be recorded. Your response will not place you under and obligation to participate in this study.
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: C25018_Sep-2026 (email_website_advert text)
