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

ConditionTED
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSinocelltech Ltd.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • SCTT11

    Drug

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

  • Placebo

    Drug

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: SCTT11 dose 1, dose 2, dose 3, dose 4Experimental treatment 1 intervention
Group B: Placebo dose 1, dose 2, dose 3, dose 4Placebo comparator 1 intervention

Trial outcomes

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

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 169 days

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

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
4

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

Time frame
Day 0 up to 169days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sinocelltech Ltd.

Lead sponsor

Source ClinicalTrials.gov

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