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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
232
YB-101 is administered over a 24 week period.
Placebo will be administered over a 24 week period.
Site 112
Gilbert, Arizona, United States
RECRUITINGSite 130
Phoenix, Arizona, United States
NOT_YET_RECRUITINGClinical Research Site
Tucson, Arizona, United States
NOT_YET_RECRUITINGSite 121
La Mesa, California, United States
RECRUITINGType and frequency of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
Time frame: 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
Time frame: Baseline, Day 169
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Site 103
Sacramento, California, United States
NOT_YET_RECRUITINGSite 111
San Francisco, California, United States
NOT_YET_RECRUITINGSite 105
Torrance, California, United States
NOT_YET_RECRUITINGSite 109
Miami Lakes, Florida, United States
RECRUITINGSite 115
Palm Harbor, Florida, United States
RECRUITINGSite 123
Sarasota, Florida, United States
NOT_YET_RECRUITING...and 20 more locations