A Multicentre, Randomized, Double-blinded, Placebo-controlled Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SCTT11 in Healthy Participants and Participants with Moderate-to-severe Thyroid Eye Disease

Sinocelltech Ltd.0 sites100 target enrollmentFebruary 19, 2025

ConditionsTED

InterventionsSCTT11 Placebo

DrugsSCTT11 Placebo

Overview

Phase: Phase 1
Intervention: SCTT11
Conditions: TED
Sponsor: Sinocelltech Ltd.
Enrollment: 100
Primary Endpoint: The occurrences of treatment-emergent adverse events (TEAE), treatment-related TEAE (TRAE), serious adverse events (SAE), and adverse events of special interest (AESI)
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

February 19, 2025

End Date

September 19, 2028

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sinocelltech Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

SCTT11 dose 1, dose 2, dose 3, dose 4

Intervention: SCTT11

Placebo dose 1, dose 2, dose 3, dose 4

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

Change from baseline in proptosis in the study eye as measured by exophthalmometer(Day 0 up to 169days)
Change from baseline in Clinical Activity Score (CAS)(Day 0 up to 169days)
Diplopia Responder Rate(Day 0 up to 169days)
Proportion of participants with a CAS of zero or one in the study eye(Day 0 up to 169days)
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)