A Study of IBI3031 in Participants With Thyroid Eye Disease

ConditionThyroid Eye Disease

Trial statusRecruiting

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

IBI3031
Drug
subcutaneous injection or intravenous infusion.
placebo
Drug
subcutaneous injection or intravenous infusion.

Treatment groups

66 Participants

are divided into 16 treatment groups

Treatment groups

See each treatment group below.

Group A: SAD Dose 4 - Placebo Control GroupPlacebo comparator 1 intervention

Group B: MAD Dose 2- IBI3031A101 Treatment GroupExperimental treatment 1 intervention

Group C: SAD Dose 4 - IBI3031A101 Treatment GroupExperimental treatment 1 intervention

Group D: MAD Dose 1 - Placebo Control GroupPlacebo comparator 1 intervention

Group E: MAD Dose 1- IBI3031A101 Treatment GroupExperimental treatment 1 intervention

Group F: MAD Dose 3 - Placebo Control GroupPlacebo comparator 1 intervention

Group G: SAD Dose 5 - IBI3031A101 Treatment GroupExperimental treatment 1 intervention

Group H: MAD Dose 2 - Placebo Control GroupPlacebo comparator 1 intervention

Group I: SAD - Dose 1 - Placebo Control GroupPlacebo comparator 1 intervention

Group J: SAD Dose 3 - IBI3031A101 Treatment GroupExperimental treatment 1 intervention

Group K: SAD Dose 2 - IBI3031A101 Treatment GroupExperimental treatment 1 intervention

Group L: SAD Dose 5 - Placebo Control GroupPlacebo comparator 1 intervention

Group M: SAD Dose 3 - Placebo Control GroupPlacebo comparator 1 intervention

Group N: MAD Dose 3- IBI3031A101 Treatment GroupExperimental treatment 1 intervention

Group O: SAD - Dose 2 - Placebo Control GroupPlacebo comparator 1 intervention

Group P: SAD Dose 1 - IBI3031A101 Treatment GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Number, incidence rate, severity, and association with the study drug of Adverse Events (AEs)

The number, incidence rate, severity, and association with the study drug of all AEs occurring throughout the trial will be summarized.

Time frame