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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Yarrow Bioscience, Inc.
Study ID
NCT07682896
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Graves' Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Experimental: YB-101 — DRUG
    YB-101 is administered over a 24 week period.
  • Placebo YB-101 — DRUG
    Placebo will be administered over a 24 week period.

Study Details

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.

Key Dates

Start date
Jun 10, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Sep 30, 2029

Study Design

Enrollment
232 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: YB-101
    In Part 1, participants will receive YB-101 via subcutaneous injection. Part 2 participants will receive YB-101 via subcutaneous injection.
  • Placebo Comparator: Placebo YB-101
    In Part 1, participants will receive placebo via subcutaneous injection. Part 2 participants will receive placebo via subcutaneous injection.

Primary Outcome Measure

Type and frequency of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) [ Time Frame: Baseline, Day 169 ]

Central Contacts

Locations (28)

FacilityCityStateZIPSite coordinators
Site 112GilbertArizona85297-
Site 130PhoenixArizona85006-
Site 121La MesaCalifornia91942-
Site 125OrangeCalifornia92868-
Site 103SacramentoCalifornia95817-
Site 111San FranciscoCalifornia94143-
Site 105TorranceCalifornia90502-
Site 109Miami LakesFlorida33016-
Site 115Palm HarborFlorida34684-
Site 123SarasotaFlorida34239-
Site 118MaconGeorgia31210-
Site 122Bowling GreenKentucky42103-
Site 126FlintMichigan48532-
Site 107LivoniaMichigan48152-
Site 108OmahaNebraska68198-
Site 129Niagara FallsNew York14304-
Site 120Orchard ParkNew York14127-
Site 104ColumbusOhio43201-
Site 124SayrePennsylvania18840-
Site 100AmarilloTexas79124-
Site 117ConroeTexas77384-
Site 128EdinburgTexas78539-
Site 127El PasoTexas79935-
Site 106Fort WorthTexas76132-
Site 110HoustonTexas77095-
Site 101HumbleTexas77346-
Site 116San AntonioTexas78233-
Site 119ChesapeakeVirginia23321-

Find similar trials in Gilbert, AZ

By research site
Site 112· Gilbert, AZSite 130· Phoenix, AZSite 121· La Mesa, CASite 125· Orange, CASite 103· Sacramento, CASite 111· San Francisco, CA

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