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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YB-101 | Experimental | In Part 1, participants will receive YB-101 via subcutaneous injection. Part 2 participants will receive YB-101 via subcutaneous injection. |
|
| Placebo YB-101 | Placebo Comparator | In Part 1, participants will receive placebo via subcutaneous injection. Part 2 participants will receive placebo via subcutaneous injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: YB-101 | Drug | YB-101 is administered over a 24 week period. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victoria Lacasse, MD | Contact | 469-278-6161 | VL@YarrowBioscience.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 112 | Not yet recruiting | Gilbert | Arizona | 85297 | United States | |
| Site 130 |
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| Placebo YB-101 |
| Drug |
Placebo will be administered over a 24 week period. |
|
| Not yet recruiting |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Site 121 | Not yet recruiting | La Mesa | California | 91942 | United States |
| Site 125 | Not yet recruiting | Orange | California | 92868 | United States |
| Site 103 | Not yet recruiting | Sacramento | California | 95817 | United States |
| Site 111 | Not yet recruiting | San Francisco | California | 94143 | United States |
| Site 105 | Not yet recruiting | Torrance | California | 90502 | United States |
| Site 109 | Not yet recruiting | Miami Lakes | Florida | 33016 | United States |
| Site 115 | Not yet recruiting | Palm Harbor | Florida | 34684 | United States |
| Site 123 | Not yet recruiting | Sarasota | Florida | 34239 | United States |
| Site 118 | Not yet recruiting | Macon | Georgia | 31210 | United States |
| Site 122 | Not yet recruiting | Bowling Green | Kentucky | 42103 | United States |
| Site 126 | Not yet recruiting | Flint | Michigan | 48532 | United States |
| Site 107 | Recruiting | Livonia | Michigan | 48152 | United States |
| Site 108 | Not yet recruiting | Omaha | Nebraska | 68198 | United States |
| Site 129 | Not yet recruiting | Niagara Falls | New York | 14304 | United States |
| Site 120 | Not yet recruiting | Orchard Park | New York | 14127 | United States |
| Site 104 | Not yet recruiting | Columbus | Ohio | 43201 | United States |
| Site 124 | Not yet recruiting | Sayre | Pennsylvania | 18840 | United States |
| Site 100 | Recruiting | Amarillo | Texas | 79124 | United States |
| Site 117 | Recruiting | Conroe | Texas | 77384 | United States |
| Site 128 | Not yet recruiting | Edinburg | Texas | 78539 | United States |
| Site 127 | Not yet recruiting | El Paso | Texas | 79935 | United States |
| Site 106 | Not yet recruiting | Fort Worth | Texas | 76132 | United States |
| Site 110 | Not yet recruiting | Houston | Texas | 77095 | United States |
| Site 101 | Recruiting | Humble | Texas | 77346 | United States |
| Site 116 | Not yet recruiting | San Antonio | Texas | 78233 | United States |
| Site 119 | Not yet recruiting | Chesapeake | Virginia | 23321 | United States |
| Site 151 | Not yet recruiting | East Melbourne | Victoria | 3002 | Australia |
| Site 150 | Not yet recruiting | Melbourne N. | Victoria | 3051 | Australia |
| ID | Term |
|---|---|
| D006111 | Graves Disease |
| D006980 | Hyperthyroidism |
| ID | Term |
|---|---|
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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