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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04151212
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Bio-Thera Solutions

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

Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Drug: BAT5906 injection Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Clinical Trial for BAT5906(Single-dose;for Injection) on Safety and Pharmacokinetics for Patients With Age-related Macular Degeneration
Actual Study Start Date : October 30, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


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 Name: No Other Intervention Names




Primary Outcome Measures :
  1. Dose-limiting toxicity(DLT) [ Time Frame: 2 weeks ]
    Safety and tolerability endpoint

  2. Maximum tolerated dosed(MTD) [ Time Frame: 0-70days ]
    Safety and tolerability endpoint

  3. Area under the curve(AUC0-t, AUC0-inf) [ Time Frame: 0-70days ]
    Pharmacokinetic endpoint Pharmacokinetic endpoint

  4. Maximum serum drug concentration(Cmax) [ Time Frame: 0-70days ]
    Pharmacokinetic endpoint Pharmacokinetic endpoint

  5. Half-life period(t1/2) [ Time Frame: 0-70days ]
    Pharmacokinetic endpoint

  6. Maximum serum drug time(Tmax) [ Time Frame: 0-70days ]
    Pharmacokinetic endpoint

  7. Plasma clearance(CL) [ Time Frame: 0-70days ]
    Pharmacokinetic endpoint


Secondary Outcome Measures :
  1. Anti-drug antibodies(ADA) [ Time Frame: 0-70days ]
    Immunogenic endpoint

  2. Best correct vision(BCVA) [ Time Frame: 0-70days ]
    Effective endpoint

  3. Central Retinal thickness(CRT) [ Time Frame: 0-70days ]
    Effective endpoint

  4. VEGF concentration [ Time Frame: 0-70days ]
    Pharmacodynamics endpoint



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04151212


Contacts
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Contact: Cailing Gu 020-22233606 clgu@bio-thera.com

Locations
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China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, China
Contact: Youxin Chen    010-69151662    chenyouxinpumch@163.com   
Sponsors and Collaborators
Bio-Thera Solutions
Investigators
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Principal Investigator: Youxin Chen Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

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Responsible Party: Bio-Thera Solutions
ClinicalTrials.gov Identifier: NCT04151212    
Other Study ID Numbers: BAT5906-001-CR
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases