A Dose Escalation Study of IBI333 in Subjects With Neovascular Age-related Macular Degeneration

NCT05639530 | Completed Phase 1

• 1 other identifier: CIBI333A101
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed for multi-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single and multiple intravitreal injection of IBI333 in subjects with neovascular age-related macular degeneration (nAMD).

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Safety and tolerance indicators

  1. Incidence, relatedness and severity of all adverse events (AE), treatment emergent adverse events (TEAE) and serious adverse events (SAE); 2. Incidence of dose limiting toxicity;

  Through study completion, a maximum of 24 weeks

Secondary Outcomes (9)

• The area under the curve (AUC) of serum concentration of the drug after the administration.

  Through study completion, a maximum of 24 weeks

• Maximum concentration (Cmax) of the drug after the administration.

  Through study completion, a maximum of 24 weeks

• Time at which maximum concentration (Tmax) occurs for the drug after the administration.

  Through study completion, a maximum of 24 weeks

• The half-life (t1/2) of drug after the administration .

  Through study completion, a maximum of 24 weeks

• Number of participants with anti-drug antibodies or neutralizing antibodies .

  Through study completion, a maximum of 24 weeks

Study Arms (2)

:treated with different doses of single intravitreal injections of IBI333

EXPERIMENTAL

Biological: IBI333 Dose 1 IBI333 of single IVT injections， Biological: IBI333 Dose 2 IBI333 of single IVT injections

Biological: IBI333

treated with different doses of multiple intravitreal injections of IBI333

EXPERIMENTAL

Biological: IBI333 Dose 3 IBI333 of multiple IVT injections， Biological: IBI333 Dose 4 IBI333 of multiple IVT injections

Biological: IBI333

Interventions

IBI333 BIOLOGICAL

Intravitreal injection of IBI333

:treated with different doses of single intravitreal injections of IBI333; treated with different doses of multiple intravitreal injections of IBI333

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
• Male or female patients ≥ 50 yrs. of age.
• Active CNV lesions secondary to neovascular AMD.
• BCVA score of 19-78 letters using ETDRS charts in the study eye.
• Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 6 months after the end of treatment.

You may not qualify if:

• Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results;
• Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular structure in the study eye;
• Active ocular or periocular inflammation/infection in either eye;
• Prior any treatment of following in the study eye:
• Anti-VEGF therapy within 90 days prior to screening;
• Intraocular glucocorticoid injection within 180 days prior to screening;
• Laser photocoagulation or photodynamic therapy within 90 days prior to screening;
• Intraocular surgery within 90 days prior to screening;
• Laser posterior capsulotomy, laser trabeculectomy or laser peripheral iridectomy within 30 days prior to screening;
• Glycated hemoglobin (HbA1c) \> 8% within 28 days prior to screening;
• Uncontrolled hypertension (defined as systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg);
• Systemic administration of steroids within 30 days prior to screening;
• Systemic administration of anti-VEGF drugs within 90 days prior to screening;
• History of severe hypersensitivity/allergic to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
• Participated in any clinical study of any other drug within 90 days prior to enrollment, or attempted to participate in other drug trials during the study;

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 101199, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: December 6, 2022
• Study Start: February 27, 2023
• Primary Completion: December 7, 2023
• Study Completion: April 23, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)