TED
Conditions
Brief summary
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
Interventions
DRUGSCTT11
SCTT11 dose 1, dose 2, dose 3, dose 4
DRUGPlacebo
Placebo dose 1, dose 2, dose 3, dose 4
Sponsors
Sinocelltech Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
for Healthy Participants: 1. Healthy male or female participants aged between18 and 45 inclusive 2. 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
Exclusion criteria
for Healthy Participants: 1.With any other disease or medical condition of clinical significance (e.g., past medical history of chronic hepatic, renal, cardiovascular, neurological/psychiatric, gastrointestinal, respiratory, urological, endocrinological, or other systemic diseases, etc.) as assessed by the investigator. Inclusion Criteria for TED Participants: 1. Male or female participants aged between 18 and 70 inclusive 2. Participants with moderate-to-severe (has an appreciable impact on daily life and requires intervention, but is not sight-threatening) TED 3. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The occurrences of treatment-emergent adverse events (TEAE), treatment-related TEAE (TRAE), serious adverse events (SAE), and adverse events of special interest (AESI) | Day 0 up to 85 days for healthy participants | — |
| Proptosis Responder Rate in the study eye | Day 0 up to 169 days | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Clinical Activity Score (CAS) | Day 0 up to 169days | — |
| Diplopia Responder Rate | Day 0 up to 169days | Diplopia Responder Rate (i.e., reduction in Gorman Subjective Diplopia Score of ≥1 from baseline for participants with baseline Gorman Subjective Diplopia Score \>0) |
| SCTT11 concentrations in the blood over time | Day 0 up to 169days | — |
| Incidence of anti-drug antibody (ADA) development in SCTT11-treated participants over time | Day 0 up to 169days | — |
| Proportion of participants with a CAS of zero or one in the study eye | Day 0 up to 169days | — |
| Change from baseline in proptosis in the study eye as measured by exophthalmometer | Day 0 up to 169days | — |
Contacts
Primary ContactMing Guo
Outcome results
None listed