A Study of SCTT11 in Healthy Participants and Participants with Thyroid Eye Disease.

Phase 1

Not yet recruiting

• Conditions: TED
• Interventions: Drug: SCTT11; Drug: Placebo

• Registration Number: NCT06769984
• Lead Sponsor: Sinocelltech Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-06
• Last Update Submitted: 2025-01-06
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Study Start: 2025-02-19
• Primary Completion: 2026-06-24
• Study Completion: 2028-09-19

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCTT11 dose 1, dose 2, dose 3, dose 4	SCTT11	-
Placebo dose 1, dose 2, dose 3, dose 4	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of anti-drug antibody (ADA) development in SCTT11-treated participants over time	Day 0 up to 169days
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	Diplopia Responder Rate (i.e., reduction in Gorman Subjective Diplopia Score of ≥1 from baseline for participants with baseline Gorman Subjective Diplopia Score \>0)
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