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

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

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 Overview

• Status: Not yet recruiting
• Conditions: TED
• Intervention / Treatment: Drug: SCTT11; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Ming Guo; Phone Number: +86-10-58628288-9127; Email: ming_guo@sinocelltech.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Criteriafor 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).

Exclusion Criteria for TED Participants:

1. Decreased best corrected visual acuity of the study eye due to optic neuropathy within 6 months prior to the first dose
2. Corneal abnormalities in study eye with no relief from treatment, as evaluated by the investigator
3. A reduction of ≥2 points in the CAS value or a reduction of ≥2 mm in proptosis in the study eye from the screening assessment period to study baseline period
4. Presence of other ocular conditions that, in the judgement of the investigator, may affect the evaluation of the study results
5. Presence of poorly controlled diabetes mellitus
6. The current presence of other uncontrolled clinical diseases or conditions
7. Abnormalities in any of the following laboratory examinations during the screening phase
8. Poorly controlled hypertension
9. With past medical histories of major surgery and/or trauma within 1 month prior to the first dose
10. With past medical histories of severe allergies, histories of severe drug allergies, known or suspected allergy to any component of this investigational product
11. Vaccination with live or live attenuated vaccine within 1 month prior to the first dose or expected during the study
12. Participation in a clinical study of any drug or device within 3 months prior to the first dose and have used the investigational product or have been treated with the device
13. Pregnant, lactating females; or participants of childbearing potential who are unwilling to use effective contraception during the study and within 180 days after the last dose
14. Other conditions evaluated by the investigator to be unsuitable for enrolment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCTT11 dose 1, dose 2, dose 3, dose 4	Drug: SCTT11; SCTT11 dose 1, dose 2, dose 3, dose 4
Placebo Comparator: Placebo dose 1, dose 2, dose 3, dose 4	Drug: Placebo; Placebo dose 1, dose 2, dose 3, dose 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	Day 0 up to 169 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Diplopia Responder Rate (i.e., reduction in Gorman Subjective Diplopia Score of ≥1 from baseline for participants with baseline Gorman Subjective Diplopia Score >0)	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

Collaborators and Investigators

• Sponsor: Sinocelltech Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): February 19, 2025
• Primary Completion (Estimated): June 24, 2026
• Study Completion (Estimated): September 19, 2028

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Genetic Diseases, Inborn; Autoimmune Diseases; Immune System Diseases; Eye Diseases, Hereditary; Graves Disease; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Thyroid Diseases; Eye Diseases; Graves Ophthalmopathy
• Other Study ID Numbers: SCTT11-X201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No