A Study of Single Intravitreal Injection HB002.1M in Subjects With Neovascular Age-Related Macular Degeneration

NCT03387566 | Completed Phase 1

• 1 other identifier: HB002.1M-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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).

Conditions

Neovascular Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Incidence of AE (Adverse Effect), DLT (Dose Limit Toxicity) and MTD (Maximum Tolerance Dose)

  Incidence of AE (Adverse Effect), DLT (Dose Limit Toxicity) and MTD (Maximum Tolerance Dose)

  Up to 1 month after the single dose

Secondary Outcomes (8)

• 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

• Immunogenicity Evaluation after single dose

  2 months

• Change in Best Corrected Visual Acuity (BCVA) from baseline

  1 month

Study Arms (5)

HB002.1M 0.3mg

EXPERIMENTAL

Participants received a 0.3mg dose of HB002.1M via intravitreal (IVT) injection.

Drug: HB002.1M

HB002.1M 0.5mg

EXPERIMENTAL

Participants received a 0.5mg dose of HB002.1M via intravitreal (IVT) injection.

Drug: HB002.1M

HB002.1M 1.0mg

EXPERIMENTAL

Participants received a 1.0mg dose of HB002.1M via intravitreal (IVT) injection.

Drug: HB002.1M

HB002.1M 2.0mg

EXPERIMENTAL

Participants received a 2.0mg dose of HB002.1M via intravitreal (IVT) injection.

Drug: HB002.1M

HB002.1M 3.0mg

EXPERIMENTAL

Participants received a 3.0mg dose of HB002.1M via intravitreal (IVT) injection.

Drug: HB002.1M

Interventions

HB002.1M DRUG

HB002.1M is a Vascular Endothelial Growth Factor Receptor Decoy.

Also known as: Recombinant Human Vascular Endothelial Growth Factor Receptor-Immunoglobulin(IgG) Fc Fusion Protein Ophthalmic Injection

HB002.1M 0.3mg; HB002.1M 0.5mg; HB002.1M 1.0mg; HB002.1M 2.0mg; HB002.1M 3.0mg

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huabo Biopharm Co., Ltd.: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: January 2, 2018
• Study Start: February 8, 2018
• Primary Completion: February 1, 2020
• Study Completion: March 23, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

CN (1)