Delving into the Latest Updates on GC801 with Synapse

Overview

Basic Info

Drug Type

Enzyme

Synonyms

GC801

Target

IgG

Action

degraders

Mechanism

IgG degraders(Immunoglobulin G degraders)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Muscular Atrophy, Spinal, Type II

Inactive Indication-

Originator Organization

Beijing GeneCradle Technology Co., Ltd.

Active Organization

Beijing GeneCradle Technology Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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主要目的评价GC801在健康参与者中单次静脉输注给药的安全性和耐受性，为II期推荐剂量（RP2D）提供依据。次要目的评价GC801的药代动力学特征；评价GC801的药效学特征和初步有效性，包括对血清总IgG及抗AAV 9中和及结合抗体滴度的影响及持续时间；评价GC801的免疫原性特征；探索GC801对多血清型AAV结合抗体滴度的影响及持续时间；探索IgG抗体裂解片段的产生及清除特征。

[Translation]

Primary Objective: To evaluate the safety and tolerability of a single intravenous infusion of GC801 in healthy participants, providing a basis for a Phase II recommended dose (RP2D). Secondary Objectives: To evaluate the pharmacokinetic characteristics of GC801; to evaluate the pharmacodynamic characteristics and preliminary efficacy of GC801, including its effects on serum total IgG and anti-AAV 9 neutralizing and binding antibody titers and their duration; to evaluate the immunogenicity of GC801; to explore the effects of GC801 on multi-serotype AAV binding antibody titers and their duration; and to explore the generation and clearance characteristics of IgG antibody cleavage fragments.

Start Date-

Sponsor / Collaborator

Beijing GeneCradle Technology Co., Ltd.

100 Clinical Results associated with GC801

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100 Translational Medicine associated with GC801

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100 Patents (Medical) associated with GC801

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100 Deals associated with GC801

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Muscular Atrophy, Spinal, Type II	IND Approval	China	Beijing GeneCradle Technology Co., Ltd.	16 Mar 2026

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Clinical Result

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Evaluation

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Approval

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Biosimilar

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