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

NCT06769984 | Not Yet Recruiting Phase 1

• 1 other identifier: SCTT11-X201
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Conditions

TED

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (2)

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

EXPERIMENTAL

Drug: SCTT11

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

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SCTT11 DRUG

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

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

Placebo DRUG

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

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female participants aged between18 and 45 inclusive
• 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

You may not qualify if:

• 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.
• Male or female participants aged between 18 and 70 inclusive
• Participants with moderate-to-severe (has an appreciable impact on daily life and requires intervention, but is not sight-threatening) TED
• 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).
• Decreased best corrected visual acuity of the study eye due to optic neuropathy within 6 months prior to the first dose
• Corneal abnormalities in study eye with no relief from treatment, as evaluated by the investigator
• 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
• Presence of other ocular conditions that, in the judgement of the investigator, may affect the evaluation of the study results
• Presence of poorly controlled diabetes mellitus
• The current presence of other uncontrolled clinical diseases or conditions
• Abnormalities in any of the following laboratory examinations during the screening phase
• Poorly controlled hypertension
• With past medical histories of major surgery and/or trauma within 1 month prior to the first dose
• With past medical histories of severe allergies, histories of severe drug allergies, known or suspected allergy to any component of this investigational product
• Vaccination with live or live attenuated vaccine within 1 month prior to the first dose or expected during the study

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Central Study Contacts

Ming Guo

CONTACT

+86-10-58628288-9127; ming_guo@sinocelltech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 10, 2025
• Study Start: February 19, 2025
• Primary Completion (Estimated): June 24, 2026
• Study Completion (Estimated): September 19, 2028
• Last Updated: January 10, 2025

Record last verified: 2024-12