NCT03387566
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- HB002.1M
- Conditions
- Neovascular Age-Related Macular Degeneration
- Sponsor
- Huabo Biopharm Co., Ltd.
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Incidence of AE (Adverse Effect), DLT (Dose Limit Toxicity) and MTD (Maximum Tolerance Dose)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
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)
Arms & Interventions
HB002.1M 0.3mg
Participants received a 0.3mg dose of HB002.1M via intravitreal (IVT) injection.
Intervention: HB002.1M
HB002.1M 0.5mg
Participants received a 0.5mg dose of HB002.1M via intravitreal (IVT) injection.
Intervention: HB002.1M
HB002.1M 1.0mg
Participants received a 1.0mg dose of HB002.1M via intravitreal (IVT) injection.
Intervention: HB002.1M
HB002.1M 2.0mg
Participants received a 2.0mg dose of HB002.1M via intravitreal (IVT) injection.
Intervention: HB002.1M
HB002.1M 3.0mg
Participants received a 3.0mg dose of HB002.1M via intravitreal (IVT) injection.
Intervention: HB002.1M
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- T1/2 (Terminal phase half life) after single dose(1 months)
- Cmax (maximum observed concentration) after single dose(1 months)
- AUC (Area Under Concentration-Time Curve) after single dose(1 months)
- Change in Best Corrected Visual Acuity (BCVA) from baseline(1 month)
- Change of VEGF(Vascular Endothelial Growth Factor A) from baseline(1 month)
- Immunogenicity Evaluation after single dose(2 months)
- Change in central retinal thickness from baseline by Optical Coherence Tomography (OCT)(1 month)
- Change in Choroidal Neovascularization (CNV) lesion area from baseline according to fluorescein angiogram(1 month)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
A Study of Injection HB002.1T in Subjects With Solid TumorSolid TumorNCT03636750Huabo Biopharm Co., Ltd.27
Withdrawn
Phase 1
3D011-08 Monotherapy in Subjects With Advanced Solid TumorsSolid Tumor, AdultNCT050995363D Medicines (Beijing) Co., Ltd.
Recruiting
Phase 1
On the Safety, Tolerability, and Efficacy of UTAA09 Injection in the Treatment of LymphomaRecurrent or Refractory B-cell Non Hodgkin's LymphomaNCT06503211The First Affiliated Hospital with Nanjing Medical University10
Completed
Phase 1
Study to Assess PK, Safety and Tolerability in Healthy SubjectsAcute Ischemic StrokeNCT06380699Changzhou Qianhong Bio-pharma Co., Ltd.56
Active, not recruiting
Phase 1
A Study to Evaluate the Safety,PK and PD of APG-2575 in Patients With Hematologic MalignanciesChronic Lymphocytic LeukemiaNon Hodgkin LymphomaNCT03913949Ascentage Pharma Group Inc.74