RECRUITING

A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

Description

This is a clinical trial assessing the safety, tolerability and pharmacokinetics (PK) of an investigational drug, VRDN-003, in participants with TED (Thyroid Eye Disease)

Conditions

Thyroid Eye Disease
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Related Conditions:

Thyroid Eye Disease

Study Overview

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Study Details

Study overview

This is a clinical trial assessing the safety, tolerability and pharmacokinetics (PK) of an investigational drug, VRDN-003, in participants with TED (Thyroid Eye Disease)

A Randomized, Open-label Study Evaluating the Safety, Tolerability and Pharmacokinetics of VRDN-003 Administered Subcutaneously in Participants With Thyroid Eye Disease (TED)

A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

Condition
Thyroid Eye Disease
Intervention / Treatment

-

Contacts and Locations

Inglewood

United Medical Research Institute, Inglewood, California, United States, 90301

Kissimmee

Ilumina Medical Research, Kissimmee, Florida, United States, 34744

Miami

Hype Clinical Research, LLC, Miami, Florida, United States, 33145

Fraser

Fraser Eye Center, Fraser, Michigan, United States, 48026

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Have a clinical diagnosis of TED with or without proptosis, with any CAS (0-7) and in the opinion of the Investigator may benefit from VRDN-003
  • * Not require immediate ophthalmological or orbital surgery in the study eye for any reason
  • * Must agree to use highly effective contraception as specified in the protocol
  • * Female TED participants must have a negative serum pregnancy test at screening
  • * Must not have received prior treatment with another anti-IGF-1R therapy
  • * Must not have received systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to first dose.
  • * Must not have received other immunosuppressive drugs for any condition, including TED, or any other therapy for TED, within 12 weeks prior to first dose
  • * Must not have received an investigational agent/device for any condition, including TED, within 8 weeks or longer (depending on the type of agent/device) prior to first dose
  • * Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
  • * Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit
  • * Must not have a pre-existing ophthalmic condition in the study eye which in the study doctor's opinion, would interfere with interpretation of study results
  • * Must not have abnormal hearing test before first dose or history of ear conditions considered significant by study doctor
  • * Must not have a history of inflammatory bowel disease
  • * Female TED participants must not be pregnant or breastfeeding

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Viridian Therapeutics, Inc.,

Study Record Dates

2026-11