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

• Sponsor: Beijing Tongren Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03725566
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 23.3
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Macular Degeneration	Drug: Experimental	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Phase I Clinical Trial of Recombinant Humanized Anti-vegf Monoclonal Antibody Single Vitreous Injection for Safety, Tolerance, PK and Pharmacodynamics in nAMD Patients
• Actual Study Start Date: May 22, 2018
• Anticipated Primary Completion Date: May 1, 2020
• Anticipated Study Completion Date: May 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. JY028 related incidence of ocular and systemic adverse events and serious adverse events [13 weeks]

   JY028 related incidence of ocular and systemic adverse events and serious adverse events

Secondary Outcome Measures

1. Cmax [13 weeks]

   Maximum blood drug concentration

2. Tmax [13 weeks]

   Peak time of blood drug concentration

3. BCVA [13 weeks]

   The best corrected visual acuity change

4. AUC0-t、AUCinf [13 weeks]

   The area under the plasma concentration time curves

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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
2. 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 -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Tongren Hospital	Beijing	Beijing	China

Sponsors and Collaborators

• Beijing Tongren Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beijing Tongren Hospital
• ClinicalTrials.gov Identifier: NCT03725566
• Other Study ID Numbers: 2017L02087
• First Posted: Oct 31, 2018
• Last Update Posted: Oct 31, 2018
• Last Verified: Sep 1, 2018

• 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
• Keywords provided by Beijing Tongren Hospital: New vascular macular degeneration
• Additional relevant MeSH terms: Macular Degeneration

Study Results

No Results Posted as of Oct 31, 2018