A Study of SCTT11 in Healthy Participants and Participants with Thyroid Eye Disease.
ConditionTED
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSinocelltech Ltd.
About this trial
Multicentre, Randomized, Double-blinded, Phase I/II Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of SCTT11 in Healthy Participants and Participants with Thyroid Eye Disease
Eligibility criteria
Qualifiers
Healthy male or female participants aged between18 and 45 inclusive
All participants must agree to not fall pregnant and voluntarily use highly effective double method contraception during the study for at least 180 days after the last dose; female participants must have a negative pregnancy test prior to dosing and must not be breastfeeding
Disqualifiers
Male or female participants aged between 18 and 70 inclusive
Participants with moderate-to-severe (has an appreciable impact on daily life and requires intervention, but is not sight-threatening) TED
Normal thyroid function, or only mild hyperthyroidism or hypothyroidism (defined as screening free triiodothyronine [FT3] and free thyroxine [FT4] levels < 50% above or below the normal limits).
Decreased best corrected visual acuity of the study eye due to optic neuropathy within 6 months prior to the first dose
Trial design
Treatments tested in this trial
- SCTT11
- Placebo
Treatment groups
100 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov