- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03387566
A Study of Single Intravitreal Injection HB002.1M in Subjects With Neovascular Age-Related Macular Degeneration
July 28, 2020 updated by: Huabo Biopharm Co., Ltd.
A Phase 1, Safety, Tolerability and Pharmacokinetic Profile Study of Intravitreous Injections of HB002.1M (a Vascular Endothelial Growth Factor Receptor Decoy) in Subjects With Neovascular Age-Related Macular Degeneration
The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of HB002.1M, a human immunoglobulin Fc fusion protein containing domain 2 and flanking sequence of vascular endothelial growth factor (VEGF) receptor-1 in subjects with age-related macular degeneration (AMD).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200080
- Shanghai General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
48 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Able and willing to provide written informed consent
- Age 50 to 80 years old of either gender
Study eye must meet following requirements:
- Active CNV lesions secondary to AMD
- A lesion area <30 mm2 (12 disc areas) of any lesion type
- BCVA ranging from 73-19 letters (20/32-20/400 Snellen equivalent), inclusive
- Clear ocular media and adequate pupil dilation to permit good quality photographic imaging
- Fellow eye must have had BCVA of 19 letters ( 20/400 Snellen equivalent) or better
Exclusion Criteria:
Any ophthalmic condition as below:
- Presence of non-exudative AMD in the study eye as determined by investigator that affect macular examination, or presence of any diseases that affect central vision (including central retinal vein occlusion, diabetic retinopathy, uveitis, vascular fringes, pathological myopia, amotio retinae, macula hole etc.
- Subretinal hemorrhage in the study eye the area of hemorrhage≥of total lesion area, or hemorrhage in central fovea≥1 disc area
- Presence of scar, fibrosis or atrophy in central fovea of the study eye
- CNV of the study eye associated with other ocular conditions , such as pathologic myopia, ocular histoplasmosis, posterior uveitis, or trauma
- Anatomic damage to the center of the fovea including fibrosis and scarring making up >50% of total lesion area including the CNV in the study eye
- History or presence of a retinal pigment epithelial tear, rhegmatogenous retinal detachment or macular hole in the study eye
- History of study eye with intraocular or any ophthalmic surgery within prior 3 months (including Laser Photocoagulation at the para fovea , cataract etc.)
- History of study eye with photodynamic therapy, macular translocation surgery trabeculectomy, Recess photocoagulation, thermal laser or external beam radiation in the study eye
- History within 6 months of screening of following treatments(such as Macugen, Lucentis, Avastin, Eylea, Conbercpet, steroids etc)
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- Uncontrolled glaucoma in the study eye (defined as intraocular pressure of >25 mmHg despite treatment with maximal medical therapy)
- History of any vitreous hemorrhage within 3 months
Any systemic conditions as below:
- Currently or potentially using any drug that will cause ocular toxicity, such as psoralen, risedronic acid; or tamoxifen etc.
- Allergic to sodium fluorescein, indocyanine green, therapeutic or diagnostic protein products, and allergic to ≥ two drugs or non-drugs, or with current allergic disease
- Uncontrolled diabetes mellitus (fast glucose level ≥7.0 mmol/L or ≥11.1 mmol/L 2h after meal)
- History of surgery and/or unhealed wound, ulcer, fracture etc. 1 month prior to screening
- Any infectious disease requiring oral, intramuscular or intravenous administrations
- History of Myocardial infarction and cerebral infarction within 6 months of screening
- Active diffuse intravascular coagulation 3 months prior to screening
- Systemic immunological diseases
- Uncontrolled hypertension ≥150 mmHg systolic or ≥95 mmHg diastolic at baseline
- Any severe or uncontrolled medical conditions (eg, unstable or progressive cardiovascular, pulmonary, Parkinson, liver, or renal disease or cancer or dementia)
Any abnormal laboratory results as below:
- Abnormal liver or kidney function test value (glutamic-oxalacetic transaminase(AST), glutamic-pyruvic transaminase(ALT), creatinine(Crea), blood urea nitrogen(BUN) that was more than 1.2 times of the upper limit of normal value)
- Abnormal coagulation test(≥3 sec of upper limit value of prothrombin time, ≥10 sec of upper limit value of activated partial thromboplastin time(APTT))
- Positive in HbsAg, hepatitis C virus(HCV) antibody, human immunodeficiency virus(HIV) antibody and syphilis antibody
Other conditions related to subjects with women of childbearing potential:
- Without using any contraceptive method
- Pregnancy or lactation (urine pregnancy test positive)
Others:
- Participated clinical studies using any medications (not including vitamins and minerals) 6 months prior to screening
- Any assessment by the investigator to be unable to or unwilling to comply with requirements of the protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HB002.1M 0.3mg
Participants received a 0.3mg dose of HB002.1M
via intravitreal (IVT) injection.
|
HB002.1M is a Vascular Endothelial Growth Factor Receptor Decoy.
Other Names:
|
Experimental: HB002.1M 0.5mg
Participants received a 0.5mg dose of HB002.1M
via intravitreal (IVT) injection.
|
HB002.1M is a Vascular Endothelial Growth Factor Receptor Decoy.
Other Names:
|
Experimental: HB002.1M 1.0mg
Participants received a 1.0mg dose of HB002.1M
via intravitreal (IVT) injection.
|
HB002.1M is a Vascular Endothelial Growth Factor Receptor Decoy.
Other Names:
|
Experimental: HB002.1M 2.0mg
Participants received a 2.0mg dose of HB002.1M
via intravitreal (IVT) injection.
|
HB002.1M is a Vascular Endothelial Growth Factor Receptor Decoy.
Other Names:
|
Experimental: HB002.1M 3.0mg
Participants received a 3.0mg dose of HB002.1M
via intravitreal (IVT) injection.
|
HB002.1M is a Vascular Endothelial Growth Factor Receptor Decoy.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of AE (Adverse Effect), DLT (Dose Limit Toxicity) and MTD (Maximum Tolerance Dose)
Time Frame: Up to 1 month after the single dose
|
Incidence of AE (Adverse Effect), DLT (Dose Limit Toxicity) and MTD (Maximum Tolerance Dose)
|
Up to 1 month after the single dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
T1/2 (Terminal phase half life) after single dose
Time Frame: 1 months
|
1 months
|
|
Cmax (maximum observed concentration) after single dose
Time Frame: 1 months
|
1 months
|
|
AUC (Area Under Concentration-Time Curve) after single dose
Time Frame: 1 months
|
1 months
|
|
Immunogenicity Evaluation after single dose
Time Frame: 2 months
|
Incidence of ADA(Anti-Drug Antibody) response
|
2 months
|
Change in Best Corrected Visual Acuity (BCVA) from baseline
Time Frame: 1 month
|
1 month
|
|
Change in central retinal thickness from baseline by Optical Coherence Tomography (OCT)
Time Frame: 1 month
|
1 month
|
|
Change in Choroidal Neovascularization (CNV) lesion area from baseline according to fluorescein angiogram
Time Frame: 1 month
|
1 month
|
|
Change of VEGF(Vascular Endothelial Growth Factor A) from baseline
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 8, 2018
Primary Completion (Actual)
February 1, 2020
Study Completion (Actual)
March 23, 2020
Study Registration Dates
First Submitted
December 11, 2017
First Submitted That Met QC Criteria
December 22, 2017
First Posted (Actual)
January 2, 2018
Study Record Updates
Last Update Posted (Actual)
July 29, 2020
Last Update Submitted That Met QC Criteria
July 28, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HB002.1M-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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