A Randomized, Double-Masked, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ETHY-001

Ethyreal Bio, Inc.

Summary

The primary objective of study is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ETHY-001 in healthy volunteers and participants with Thyroid Eye Disease after single subcutaneous doses.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria: Parts A and B: * Body mass index of 18 kg/m2 at screening. * Agree to comply with all protocol requirements. * Able to provide written informed consent. * Agree to defined medications and monitoring as instructed by the site. Other protocol-defined inclusion criteria will apply. Part B Only: \- Must meet the criteria for moderate-to-severe TED. Exclusion Criteria: Part A and Part B: * Significant medical conditions or physical findings that may affect participant safety. * Active liver or kidney dysfunction at screening. * Known hypersensitivity to monoclonal antibo…

Interventions

Drug
ETHY-001
ETHY-001
Other
Placebo
Placebo

Location

Site 101
Las Vegas, Nevada

A Randomized, Double-Masked, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ETHY-001

Summary

Eligibility

Interventions

Location

Run this study?

Details

Conditions