A Study of IBI3031 in Participants With Thyroid Eye Disease
ConditionThyroid Eye Disease
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInnovent Biologics (Suzhou) Co. Ltd.
About this trial
This is a multicenter, randomized, double-masked, placebo-controlled, single/multiple-dose-escalation trial conducted in Chinese participants with Thyroid Eye Disease (TED), aiming to evaluate the safety and tolerability of IBI3031 administered via subcutaneous or intravenous injection.
Eligibility criteria
Qualifiers
Written informed consent.
Aged between 18 and 75 years at screening.
Weight between 45 kg and 100 kg.
CAS ≥ 3 in the study eye at screening and baseline;
Disqualifiers
The CAS of the study eye at baseline is reduced by ≥ 2 points compared with that at screening, or the proptosis of the study eye at baseline is reduced by ≥ 2 mm compared with that at screening;
Participants previously diagnosed with dysthyroid optic neuropathy (DON), or with DON as determined by the investigator at screening;
Patients with corneal ulcers that are not relieved after treatment at the investigator's discretion;
Presence of other non-TED ophthalmic diseases that may affect the interpretation of study results or the safety of participants as determined by the investigator (e.g., proptosis not primarily caused by TED);
Trial design
Treatments tested in this trial
- IBI3031
- placebo
Treatment groups
66 Participants
are divided into 16 treatment groups16
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov