SCTT11
DrugSCTT11 dose 1, dose 2, dose 3, dose 4
NCT Number: NCT06769984
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
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Phase 1 / Phase 2
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Healthy Participants:
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:
Exclusion criteria
for TED Participants:
SCTT11 dose 1, dose 2, dose 3, dose 4
Placebo dose 1, dose 2, dose 3, dose 4
Time frame: Day 0 up to 85 days for healthy participants
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)
Time frame: Day 0 up to 169days
Time frame: Day 0 up to 169days
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)
Time frame: Day 0 up to 169days
Time frame: Day 0 up to 169days
Time frame: Day 0 up to 169days
Contact information is provided by the study sponsor or research team.
Sinocelltech Ltd.
Industry
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
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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