[Translation] A randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics of MWX203 injection after a single subcutaneous administration in healthy Chinese subjects

主要目的： 1、评估MWX203注射液在中国健康受试者中单次给药的安全性、耐受性。次要目的： 1、评估 MWX203 注射液在中国健康受试者中单次给药的药代动力学； 2、评估 MWX203 在中国健康受试者中单次给药的免疫原性。探索性目的： 1、评估 MWX203 注射液在中国健康受试者中单次给药的药效学； 2、评估 MWX203 可能的代谢产物。

[Translation]

Primary objectives: 1. To evaluate the safety and tolerability of a single dose of MWX203 injection in healthy Chinese subjects. Secondary objectives: 1. To evaluate the pharmacokinetics of a single dose of MWX203 injection in healthy Chinese subjects; 2. To evaluate the immunogenicity of a single dose of MWX203 in healthy Chinese subjects. Exploratory objectives: 1. To evaluate the pharmacodynamics of a single dose of MWX203 injection in healthy Chinese subjects; 2. To evaluate the possible metabolites of MWX203.

Start Date25 Jun 2025

Sponsor / Collaborator

Shanghai Minwei Biotechnology Co., Ltd

CTR20262397

/ Not yet recruitingPhase 2

评价MWX203注射液单药或联合英克司兰钠注射液在血脂控制不佳的混合型血脂异常参与者中有效性和安全性的多中心、随机、盲法、安慰剂对照Ⅱ期临床研究

[Translation] This is a multicenter, randomized, blinded, placebo-controlled phase II clinical trial evaluating the efficacy and safety of MWX203 injection alone or in combination with inxilem sodium injection in participants with poorly controlled mixed dyslipidemia.

评估MWX203注射液单药或联合英克司兰钠注射液在接受稳定他汀类药物治疗血脂控制不佳的混合型血脂异常参与者中多次给药的有效性、安全性、其他有效性

[Translation]

Evaluate the efficacy, safety, and other efficacy of MWX203 injection monotherapy or in combination with inxilem sodium injection in multiple-dose participants with mixed dyslipidemia who have poor lipid control on stable statin therapy.

Start Date-

Sponsor / Collaborator

Shanghai Minwei Biotechnology Co., Ltd

100 Clinical Results associated with MWX-203

100 Translational Medicine associated with MWX-203

100 Patents (Medical) associated with MWX-203

100 Deals associated with MWX-203

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dyslipidemias	Phase 2	China	Shanghai Minwei Biotechnology Co., Ltd	22 Jun 2026
Complex dyslipidemia	Preclinical	China	Shanghai Minwei Biotechnology Co., Ltd	01 Dec 2024
Hyperlipidemias	Preclinical	China	Shanghai Minwei Biotechnology Co., Ltd	18 Apr 2024

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