JY028 Single Vitreous Injection in a Phase 1 Clinical Trial in nAMD Patients

Phase I Clinical Trial of Recombinant Humanized Anti-vegf Monoclonal Antibody Single Vitreous Injection for Safety, Tolerance, PK and Pharmacodynamics in nAMD Patients

Phase I clinical trial on safety, tolerance, pharmacokinetics (PK) and pharmacodynamics of recombinant human anti-VEGF monoclonal antibody injection in patients with neovascular (wet) age-related macular degeneration

Study Overview

• Status: Unknown
• Conditions: Macular Degeneration
• Intervention / Treatment: Drug: Experimental

Detailed Description

Test drug:Recombinant humanized anti VEGF monoclonal antibody injection; Research Phase:Phase I; Subjects:Subjects with neovascular (wet) age-related macular degeneration; Number of Subjects:24; Trial design:Single center, non randomized, open, single arm, single dose, dose escalation; Research objective:to rearch the safety and tolerance of JY028 injection;to rearch PK of JY028 injection;to observe the efficacy of JY028 in the treatment of nAMD;to rearch the relationship between plasma VEGF concentration and JY028 concentration. to rearch immunogenicity of JY028;

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing Tongren Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The patient volunteered to participate and signed the informed consent 2. No more than 50 years of age and less than 75 years of age, male or female 3. Diagnosed as nAMD 4. The optimal corrected visual acuity of the target eye ETDRS should be no more than 50 letters, and the optimal corrected visual acuity of the opposite eye should be no more than 34 letters 5. The target eye pressure is no more than 25mmHg, which can be controlled by drugs 6. A normal coagulation function: the platelet count is 100 x 10 ^ 9-300x 10^10 / L, thrombin time, prothrombin time within the normal range.

-

Exclusion Criteria:

1. Choroid polypoid angiopathy (PCV)
2. There are other obvious eye diseases/conditions (such as diabetic retinopathy, cataract, abnormal eyelid, uncontrolled glaucoma, eye active inflammation, etc.)
3. CNV caused by other causes other than nAMD, such as diabetic retinopathy, vascular stripe disease, ocular histoplasmosis, case myopia, trauma, etc
4. The target eye has received any intraocular surgery or laser therapy within 3 months prior to enrollment
5. Any eye treated with antiangiogenic drugs within 3 months prior to baseline visit
6. Patients with active eye infections, such as conjunctivitis, keratitis, sclerotic, blepharitis, endophthalmitis or uveitis
7. Persons with a history of myocardial infarction and/or cerebral infarction or other active or acute cardiovascular diseases
8. HIV antibody/hiv-p24 antigen, any of the positive subjects in the treponema pallidum antibody
9. Active HBsAg carriers (conditions must be met: HBsAg positive, HBV DNA positive, ALT higher than normal upper limit)
10. Patients with HCV (the following conditions must be met: lgM positive anti-hcv antibody, ALT higher than the upper limit of normal value)
11. Fluorescein sodium allergy
12. Allergy to anti-vegf monoclonal antibodies or humanized monoclonal antibodies
13. Patients who participated in other clinical trials within 3 months
14. Patients who took NSAIDs and aspirin or other anticoagulant or platelet drugs within 1 month before enrollment
15. An unhealed wound, ulcer, fracture, or other related medical condition
16. Patients with uncontrollable hypertension, with systolic blood pressure of > 140mmHg and diastolic blood pressure of > 90mmHg
17. Patients with uncontrollable clinical diseases or problems (such as serious mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant tumors)
18. Pregnant and lactating women and those who cannot take contraceptive measures
19. According to the researcher, it is not suitable for the candidate -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Recombinant humanized anti-VEGF monoclonal antibody injection 0.625mg/1.25mg/2.0mg/2.5mg by intravitreous injection,day 1 in the first month;	Drug: Experimental; Recombinant humanized anti-VEGF monoclonal antibody injection 0.625mg/1.25mg/2.0mg/2.5mg by intravitreous injection,day 1 in the first month; Other Names: intravitreous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
JY028 related incidence of ocular and systemic adverse events and serious adverse events	JY028 related incidence of ocular and systemic adverse events and serious adverse events	13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum blood drug concentration	13 weeks
Tmax	Peak time of blood drug concentration	13 weeks
BCVA	The best corrected visual acuity change	13 weeks
AUC0-t、AUCinf	The area under the plasma concentration time curves	13 weeks

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital
• Investigators: Principal Investigator: xiu li zhao, doctor, Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2018
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): October 31, 2018
• Last Update Submitted That Met QC Criteria: October 30, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: New vascular macular degeneration
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: 2017L02087

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes