A Phase I Clinical Trial of BAT5906 Injection in Patients With Wet Age-related Macular Degeneration

A Phase I Clinical Trial for BAT5906(Single-dose;for Injection) on Safety and Pharmacokinetics for Patients With Age-related Macular Degeneration

A Phase I Clinical Trial for BAT5906(single-dose;for injection) on Safety and Pharmacokinetics for Patients with Age-related macular degeneration.

Study Overview

• Status: Completed
• Conditions: Age-related Macular Degeneration
• Intervention / Treatment: Drug: BAT5906 injection

Detailed Description

The primary objective: To evaluate the safety and Pharmacokinetics of BAT5906 (single-dose Ophthalmic Intracireal Iinjection) in patients wAMD , when the injection dosage escalates.

The Secondary objective: To evaluate the immunogenicity profile of BAT5906; To evaluate the pharmacodynamics and therapeutic efficacy profile of BAT5906.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female aged 50-80 years old .
• Signing the informed consent form and able and willing to comply with all treatment and follow-up study procedures.
• The study eye must meet all the following inclusion criteria: To be diagnosed as wet age related macular degeneration, and there are still active lesions currently;Total lesion size of ≤30mm2( 12 disc areas);Best corrected visual acuity ≤70 Early Treatment of Diabetic Retinopathy ;Study letters (≤20/40) in the study eye.
• Best corrected visual acuity ≥34 Early Treatment of Diabetic Retinopathy Study letters (≥20/200) . in the non-study eye.

Exclusion Criteria:

• There are atrophy of the ground pattern involving the fovea, scar or fibrosis, macular anterior membrane, rigid exudation under dense fovea, RPE tear in the study eye.
• Retinal hemorrhage ≥4 disc area in the study eye.
• Dioptric media turbid or the pupil cannot be dilated were significant interference with the detection of vision, the evaluation of the anterior segment and fundus in the study eye.
• Evidence of ocular disease other than exudative AMD in the study eye that may confound the outcome of the study (e.g.,Retinal vein occlusion, uveitis, vascular striatum, pathological myopia, retinal detachment, macular hole, toxoplasmosis, optic nerve disease etc).
• History of vitrectomy surgery\macular transposition\glaucoma filtration in the study eye.
• Photodynamic therapy(PDT), in macular area laser photocoagulation therapy, transpermary hyperthermia(TTT), and other operations for AMD within 3 months prior to screening visit in the study eye.
• History of extraocula surgeryr within 1 months or cataract surgery within 3 months prior to screening visit in the study eye.
• Aphakia(exclusive of intraocular lens) or rupture of posterior capsule( within1 months prior to the YAG laser retrovesiculotomy (after the artificial crystal), was excluded) in the study eye.
• APD in the study eye or pseudocyst stripping syndrome in either eye.
• Intravitrea or Systemicl anti-VEGF injection (ranibizumab, aflibercept, bevacizumab or Conbercept etc) in either eye within 3 months prior to screening visit.
• Under the conjunctiva,intravitreal or periocular corticosteroid, within 3 months prior to screening visit in either eye.
• vitreous hemorrhage within 3 months prior to screening Visit in either eye.
• Ocular or periocular infection in either eye.
• History of glaucoma in either eye.
• Visudyne (verteporfin) photodynamic therapy within 1 months prior to screening Visit in non-study eye.
• Currently in use or may be required to use systemic drugs that cause crystal toxicity or retinal toxicity, such as Deferoxamine, chloroquine/ hydroxychloroquine, phenothiazine and ethambutol or tamoxifen etc.
• Have an allergic reaction or history of allergic reactions to fluorescein sodium and indocyanine green, an allergic history to therapeutic or diagnostic protein products, an allergic reaction to more than two drugs or non-drug factors, or allergic reactions to any monoclonal antibody.
• Patients with diabetic retinopathy or the diabetic patient who have glycosylated? hemoglobin>10%.
• Patients who have undergone any surgical operation within 1 month prior screening; or/and there are unhealed wounds, ulcers, fractures etc.
• Systemic infectious diseases with clinical significance requiring oral, intramuscular or Patients withintravenous administration.
• Myocardial infarction, cerebral infarction and angina pectoris within 6 months prior to screening visit.
• Patients with active disseminated intravascular coagulation and obvious bleeding tendency were screened within 3 months before the screening, or they were treated with anticoagulant and antiplatelet therapy other than aspirin/NSAIDs within 14 days before the screening.
• Patients with Systemic immune disease ,including but not limited to:

hyperthyroidism, hypothyroidism,vitiligo, dry-syndrome, ankylosing spondylitis, systemic nephritis, human immunodeficiency virus (HIV).

• Blood pressure control is not ideal or pre-hypertension.
• Any uncontrollable clinical problems (Serious mental, nervous, cardiovascular and respiratory diseases and malignant tumors).
• Abnormal liver and kidney function.
• Blood coagulation is abnormal.
• Patients with AIDS, syphilis or active hepatitis.
• Women are not using effective contraception or in pregnancy,lactation.
• Clinical trials of any trial medication or any other experimental or experimental therapy may be performed within 3 months prior to screening.
• Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BAT5906 injection; Single dose escalation starting from 0.3mg. Route of administration: intravitreal injection.	Drug: BAT5906 injection; Signal dose escalation starting from 0.3mg. Route of administration: intravitreal injection; Other Names: No Other Intervention Names

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-limiting toxicity(DLT)	Safety and tolerability endpoint	2 weeks
Maximum tolerated dosed(MTD)	Safety and tolerability endpoint	0-70days
Area under the curve(AUC0-t, AUC0-inf)	Pharmacokinetic endpoint Pharmacokinetic endpoint	0-70days
Maximum serum drug concentration(Cmax)	Pharmacokinetic endpoint Pharmacokinetic endpoint	0-70days
Half-life period(t1/2)	Pharmacokinetic endpoint	0-70days
Maximum serum drug time(Tmax)	Pharmacokinetic endpoint	0-70days
Plasma clearance(CL)	Pharmacokinetic endpoint	0-70days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-drug antibodies(ADA)	Immunogenic endpoint	0-70days
Best correct vision(BCVA)	Effective endpoint	0-70days
Central Retinal thickness(CRT)	Effective endpoint	0-70days
VEGF concentration	Pharmacodynamics endpoint	0-70days

Collaborators and Investigators

• Sponsor: Bio-Thera Solutions
• Investigators: Principal Investigator: Youxin Chen, Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2018
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: BAT5906-001-CR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No