[Translation] A multicenter, randomized, double-blind, active drug-controlled Phase II clinical study to evaluate the safety and efficacy of different doses and dosing regimens of HB002.1M in patients with diabetic macular edema

1. 主要研究目的：观察和比较HB002.1M不同剂量及不同给药方案在DME患者中的安全性。 2. 次要研究目的： 1) 初步探索并比较HB002.1M不同剂量及不同给药方案在DME患者中的有效性； 2) 初步比较HB002.1M与康柏西普在DME患者中的疗效差异； 3) 探索HB002.1M多次给药的免疫原性、药代动力学及药效学特征。

[Translation]

1. Main research objectives: To observe and compare the safety of different doses and different dosing regimens of HB002.1M in patients with DME. 2. Secondary research objectives: 1) To preliminarily explore and compare the effectiveness of different doses and different dosing regimens of HB002.1M in patients with DME; 2) To preliminarily compare the efficacy differences between HB002.1M and Conbercept in patients with DME; 3) To explore the immunogenicity, pharmacokinetics and pharmacodynamic characteristics of multiple dosing of HB002.1M.

Start Date11 Oct 2021

Sponsor / Collaborator

Huabo Biopharm Co Ltd.

CTR20200948

/ RecruitingPhase 2

评价HB002.1M在湿性年龄相关性黄斑变性患者中的安全性和疗效的多中心，随机，双盲，阳性药物对照的IIa期临床研究

[Translation] A multicenter, randomized, double-blind, active-controlled Phase IIa clinical study to evaluate the safety and efficacy of HB002.1M in patients with wet age-related macular degeneration

观察和比较不同剂量 HB002.1M 在湿性AMD患者中多次给药的安全性；初步探索不同剂量的给药间隔及疗效，推荐后期临床试验的合理剂量及治疗间隔；探索HB002.1M多次给药的药代动力学研究特征。

[Translation]

Observe and compare the safety of multiple administrations of different doses of HB002.1M in patients with wet AMD; preliminarily explore the dosing intervals and efficacy of different doses, and recommend reasonable doses and treatment intervals for later clinical trials; explore the pharmacokinetic research characteristics of multiple administrations of HB002.1M.

Start Date16 Dec 2020

Sponsor / Collaborator

Huabo Biopharm Co Ltd.

NCT03387566

/ CompletedPhase 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

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).

Start Date08 Feb 2018

Sponsor / Collaborator

Huabo Biopharm Co Ltd.

100 Clinical Results associated with HB002.1M

100 Translational Medicine associated with HB002.1M

100 Patents (Medical) associated with HB002.1M

100 Deals associated with HB002.1M

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic macular oedema	Phase 2	China	Shanghai Huaaotai Biopharmaceutical Co., Ltd.	27 Apr 2022
Wet age-related macular degeneration	Phase 2	China	Huabo Biopharm Co Ltd.	16 Dec 2020
Retinal vein occlusion-related macular edema	IND Approval	China	Shanghai Huaaotai Biopharmaceutical Co., Ltd.	28 Sep 2020

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