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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
The occurrences of treatment-emergent adverse events (TEAE), treatment-related TEAE (TRAE), serious adverse events (SAE), and adverse events of special interest (AESI)
Time frame: Day 0 up to 85 days for healthy participants
Proptosis Responder Rate in the study eye
Proptosis Responder Rate in the study eye (i.e., reduction of proptosis of ≥ 2 mm from baseline without a corresponding increase of ≥ 2 mm in the fellow eye\] as measured by exophthalmometer)
Time frame: Day 0 up to 169 days
Change from baseline in proptosis in the study eye as measured by exophthalmometer
Time frame: Day 0 up to 169days
Change from baseline in Clinical Activity Score (CAS)
Time frame: Day 0 up to 169days
Diplopia Responder Rate
Diplopia Responder Rate (i.e., reduction in Gorman Subjective Diplopia Score of ≥1 from baseline for participants with baseline Gorman Subjective Diplopia Score \>0)
Time frame: Day 0 up to 169days
Proportion of participants with a CAS of zero or one in the study eye
Time frame: Day 0 up to 169days
SCTT11 concentrations in the blood over time
Time frame: Day 0 up to 169days
Incidence of anti-drug antibody (ADA) development in SCTT11-treated participants over time
Time frame: Day 0 up to 169days
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