Safety, Tolerability and Efficacy Study of VRDN 001 in Persons With Thyroid Eye Disease (TED)
Research type
Research Study
Full title
A multiple ascending dose (MAD) safety, tolerability and efficacy study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in normal healthy volunteers (NHVs) and subjects with thyroid eye disease (TED)
IRAS ID
1005149
Contact name
Vicki Lee
Contact email
Eudract number
2021-006794-37
Clinicaltrials.gov Identifier
Research summary
This is a research study funded by Viridian Therapeutics to evaluate the safety and effectiveness of a drug called VRDN-001 as a potential treatment for thyroid eye disease (TED).
VRDN-001 is an experimental drug that will be given by intravenous infusion into a vein in the arm.
The study is split into three parts. In the first part, VRDN-001 will be given to healthy volunteers in different doses, starting at a low dose and increasing to higher doses when an independent Data Safety Monitoring Board says that it is safe to do so. Healthy volunteers will be monitored at a specialist clinic in the USA.
In the second part, patients who have TED will be given different doses of VRDN-001 to check how the body tolerates and reacts to the drug. The effect of the drug on TED will also be recorded. The first two parts of the study are called a multiple ascending dose, or MAD, study.
The final part of the study is an extension which will test the effectiveness of different doses or number of doses of VRDN-001.
In all three parts, participants will receive either VRDN-001 or a placebo. The placebo is used to compare results to the drug. Neither the researchers nor the participants will know which they receive.
There will be between 12-16 healthy volunteers and 16-32 participants with TED participating in the MAD study and another 48 people with TED will participate in the extension study. The MAD study will last for 24 weeks, and the extension study will last for 52 weeks. Participants with TED who live in the UK, EU, or USA may be able to take part.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
22/SC/0085
Date of REC Opinion
9 May 2022
REC opinion
Further Information Favourable Opinion