Delving into the Latest Updates on Sinolink Pharma (Suzhou) Limited with Synapse

Overview

Tags

Congenital Disorders

Immune System Diseases

Respiratory Diseases

Monoclonal antibody

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Immune System Diseases	1

Top 5 Drug Type	Count

Monoclonal antibody	1

Top 5 Target	Count

IL17RB(Interleukin-17 receptor B)	1

第一部分：Ia期健康受试者研究主要目的：评估SM17在中国健康成人受试者中单次及多次给药的安全性和耐受性。次要目的：评估SM17在中国健康受试者中单次及多次给药后的药代动力学（PK）特征。评估SM17在中国健康受试者中的免疫原性。第二部分：Ib期成年中重度特应性皮炎患者研究主要目的：评估SM17在成年中重度特应性皮炎患者中多次给药的安全性与耐受性。次要目的：评估SM17在成年中重度特应性皮炎患者中多次给药的PK特征。评估SM17在成年中重度特应性皮炎患者中的免疫原性。评估SM17治疗成年中重度特应性皮炎患者的初步有效性。探索性目的：探索SM17在成年中重度特应性皮炎患者中多次给药后的药效学（PD）特征。探索SM17多次给药后的PK/PD相关性。探索PD标志物与特应性皮炎有效性评估指标之间的相关性。

[Translation]

Part I: Phase Ia healthy subject study Primary objective: To evaluate the safety and tolerability of SM17 after single and multiple administrations in healthy Chinese adult subjects. Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of SM17 after single and multiple administrations in healthy Chinese subjects. To evaluate the immunogenicity of SM17 in healthy Chinese subjects. Part II: Phase Ib study in adult patients with moderate to severe atopic dermatitis Primary objective: To evaluate the safety and tolerability of SM17 after multiple administrations in adult patients with moderate to severe atopic dermatitis. Secondary objective: To evaluate the PK characteristics of SM17 after multiple administrations in adult patients with moderate to severe atopic dermatitis. To evaluate the immunogenicity of SM17 in adult patients with moderate to severe atopic dermatitis. To evaluate the preliminary efficacy of SM17 in the treatment of adult patients with moderate to severe atopic dermatitis. Exploratory objective: To explore the pharmacodynamic (PD) characteristics of SM17 after multiple administrations in adult patients with moderate to severe atopic dermatitis. To explore the PK/PD correlation of SM17 after multiple administrations. To explore the correlation between PD markers and effectiveness evaluation indicators for atopic dermatitis.

Start Date21 Nov 2023

Sponsor / Collaborator

Sinolink Pharma (Suzhou) Limited

CTR20202676 / CompletedPhase 1

评价SN1011在健康受试者中单次及多次给药的安全性、耐受性、药代动力学、药效动力学的随机、双盲、安慰剂对照的Ⅰ期临床研究

[Translation] A randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of SN1011 in healthy subjects

主要目的：评价SN1011在中国健康成年受试者中单次和多次给药后的安全性和耐受性；次要目的：评估SN1011单次和多次口服给药后的药代动力学（PK）特征；探索性目的：探索SN1011单次和多次口服给药后的药效动力学（PD）特征；探索单次和多次口服给药后SN1011的 PK/PD 相关性；探索SN1011给药后血浆中SN1011的代谢物类型及主要代谢物的药代动力学特征（如适用）。

[Translation]

Primary objective: To evaluate the safety and tolerability of SN1011 after single and multiple administrations in healthy adult Chinese subjects; Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of SN1011 after single and multiple oral administrations; Exploratory objective: To explore the pharmacodynamic (PD) characteristics of SN1011 after single and multiple oral administrations; To explore the PK/PD correlation of SN1011 after single and multiple oral administrations; To explore the metabolite types of SN1011 in plasma after SN1011 administration and the pharmacokinetic characteristics of the main metabolites (if applicable).

Start Date11 Jan 2021

Sponsor / Collaborator

Sinolink Pharma (Suzhou) Limited

100 Clinical Results associated with Sinolink Pharma (Suzhou) Limited

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0 Patents (Medical) associated with Sinolink Pharma (Suzhou) Limited

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100 Deals associated with Sinolink Pharma (Suzhou) Limited

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100 Translational Medicine associated with Sinolink Pharma (Suzhou) Limited

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Pipeline

Pipeline Snapshot as of 23 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

IND Approval

1

Phase 1 Clinical

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