A Safety, Tolerability and Efficacy Study of VRDN 001 in Healthy Volunteers and Persons With Thyroid Eye Disease (TED)

Open to people ages 18 years and up

for Healthy Volunteers:

- Must be free of clinically significant disease or medical conditions as determined by the Investigator - Female volunteers must not be of child-bearing potential

for Healthy Volunteers:

• Must not have a history of or any evidence of diabetes mellitus, recently diagnosed renal impairment or inflammatory bowel disease, or clinically significant ear pathology or hearing impairment Key Inclusion Criteria for Participants with TED: - Must have moderate to severe active TED with documented evidence of ocular symptoms or signs that began within 1 year prior to screening - Must have Clinical Activity Score (CAS) of ≥ 4 on the 7-item scale for the study (more proptotic) eye - Must agree to use highly effective contraception as specified in the protocol - Female TED participants must have a negative serum pregnancy test Key Exclusion Criteria for Participants with TED: - Must not have received prior treatment with another anti-IGF-1R monoclonal antibody - Must not have used oral corticosteroids within 4 weeks prior to Day 1 - Must not have received rituximab, tocilizumab or other immunosuppressive agents within 90 days prior to Day 1 - Must not have evidence of optic nerve involvement within the previous 6 months - Must not have corneal decompensation in the study eye unresponsive to medical management - Must not have had previous orbital irradiation or surgery for TED in the study eye - Must not have a history inflammatory bowel disease, or clinically significant ear pathology or hearing impairment - Must not have received an investigational agent for any condition within 60 days - Female TED participants must not be pregnant or lactating