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

Inclusion Criteria:

• Have a clinical diagnosis of TED with or without proptosis, with any CAS (0-7) andin the opinion of the Investigator may benefit from VRDN-003

• Not require immediate ophthalmological or orbital surgery in the study eye for anyreason

• Must agree to use highly effective contraception as specified in the protocol

• Female TED participants must have a negative serum pregnancy test at screening

Key Exclusion Criteria:

• Must not have received prior treatment with another anti-IGF-1R therapy

• Must not have received systemic corticosteroids for any condition, including TED, orselenium within 2 weeks prior to first dose.

• Must not have received other immunosuppressive drugs for any condition, includingTED, or any other therapy for TED, within 12 weeks prior to first dose

• Must not have received an investigational agent/device for any condition, includingTED, within 8 weeks or longer (depending on the type of agent/device) prior to firstdose

• Must not have received radioactive iodine (RAI) treatment within 8 weeks prior tofirst dose

• Must not have had previous orbital irradiation or decompression surgery for TED tothe study eye's orbit

• Must not have a pre-existing ophthalmic condition in the study eye which in thestudy doctor's opinion, would interfere with interpretation of study results

• Must not have abnormal hearing test before first dose or history of ear conditionsconsidered significant by study doctor

• Must not have a history of inflammatory bowel disease

• Female TED participants must not be pregnant or breastfeeding