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NCT Number: NCT06769984

A Study of SCTT11 in Healthy Participants and Participants with 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

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Key information

Conditions

TED

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 criteria

for 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

Treatment and study plan

SCTT11

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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

  2. 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

  1. Change from baseline in proptosis in the study eye as measured by exophthalmometer

    Time frame: Day 0 up to 169days

  2. Change from baseline in Clinical Activity Score (CAS)

    Time frame: Day 0 up to 169days

  3. Diplopia Responder Rate

    Time frame: 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)

  4. Proportion of participants with a CAS of zero or one in the study eye

    Time frame: Day 0 up to 169days

  5. SCTT11 concentrations in the blood over time

    Time frame: Day 0 up to 169days

  6. Incidence of anti-drug antibody (ADA) development in SCTT11-treated participants over time

    Time frame: Day 0 up to 169days

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Sinocelltech Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Jan 10, 2025
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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