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

Официальное название

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

Обзор

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

Вмешательства

• Препарат SCTT11
  SCTT11 dose 1, dose 2, dose 3, dose 4
• Препарат Placebo
  Placebo dose 1, dose 2, dose 3, dose 4

Первичные конечные точки

• The occurrences of treatment-emergent adverse events (TEAE), treatment-related TEAE (TRAE), serious adverse events (SAE), and adverse events of special interest (AESI) [Срок оценки: Day 0 up to 85 days for healthy participants]
• Proptosis Responder Rate in the study eye [Срок оценки: Day 0 up to 169 days]

Вторичные конечные точки (6)

• Change from baseline in proptosis in the study eye as measured by exophthalmometer [Срок оценки: Day 0 up to 169days]
• Change from baseline in Clinical Activity Score (CAS) [Срок оценки: Day 0 up to 169days]
• Diplopia Responder Rate [Срок оценки: Day 0 up to 169days]
• Proportion of participants with a CAS of zero or one in the study eye [Срок оценки: Day 0 up to 169days]
• SCTT11 concentrations in the blood over time [Срок оценки: Day 0 up to 169days]
• Incidence of anti-drug antibody (ADA) development in SCTT11-treated participants over time [Срок оценки: Day 0 up to 169days]

Критерии участия

Inclusion Criteria for Healthy Participants:

• 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

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:

• 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).

Exclusion Criteria for TED Participants:

• 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
• 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
• 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
• Other conditions evaluated by the investigator to be unsuitable for enrolment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06769984 · SCTT11-X201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗