Evaluation of YB-101 for Safety, Tolerability, Pharmacokinetics, and Efficacy in Graves' Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

Experimental: YB-101: YB-101 is administered over a 24 week period.

Placebo YB-101: Placebo will be administered over a 24 week period.

Study summary

This study is being conducted to look at the effect YB-101 has on thyroid function. This study will also evaluate how safe and well tolerated YB-101 is and how it is distributed through the body.

The study consists of a part 1, blinded treatment period, and a part 2 double-blinded treatment period. Participants will receive YB-101 or Placebo subcutaneously. Participants who participate in Part 1 can not participate in Part 2.

Participants will complete 34-39 in-clinic visits in Part 1 or Part 2 over an approximate 40 week period.

Eligibility

Primary outcome measure(s)

• Type and frequency of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) — Baseline, Day 169
• Proportion of participants with normal free triiodothyronine (FT3), free thyroxine (FT4), and thyroid-stimulating hormone (TSH) who discontinued anti-thyroid drugs (ATDs), regardless of concomitant levothyroxine use — Baseline, Day 169

Trial sites (29)

Other trials for the same condition