An Efficacy and Safety Study of NTB003 in Participants With Thyroid Eye Disease (TED)

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNanjing Chia-tai Tianqing Pharmaceutical

About this trial

Multicentre, Phase Ib/II Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of NTB003 in Participants with Thyroid Eye Disease

Eligibility criteria

Qualifiers

1. Male or female subjects aged 18-75 years who have signed informed consent. 2.Body weight between 40 kg and 100 kg. 3.Clinical diagnosis of thyroid eye disease (TED): Active thyroid eye disease (TED): at least one eye with a CAS ≥ 3 and proptosis ≥ 3 mm above the upper limit of normal in that eye, and the subject's first onset of TED ocular signs/symptoms (by subject report or medical records) occurred within 1 year prior to first study drug administration; Chronic Thyroid Eye Disease (TED) : bilateral CAS < 3, and the first onset of TED ocular signs/symptoms (by subject report or medical records) occurred > 12 months prior to first study drug administration.

Disqualifiers

1. 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.

Trial design

Treatments tested in this trial

  • NTB003
  • NTB003
  • NTB003
  • NTB003 and Placebo

Treatment groups

74 Participants
are divided into 4 treatment groups

Locations

This trial has no locations