Delving into the Latest Updates on SSS39 with Synapse

Overview

Basic Info

Drug Type

Molecular glue

Synonyms

Target-

Action-

Mechanism-

Therapeutic Areas

Immune System Diseases

Active Indication

Immunosuppression

Inactive Indication-

Originator Organization

Shenyang Sunshine Pharmaceuticals Co., Ltd.

Active Organization

Shenyang Sunshine Pharmaceuticals Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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主要目的：评价SSS39注射剂在中国健康成年受试者中单次静脉输注给药的安全性和耐受性。次要目的：评价SSS39注射剂在中国健康成年受试者中单次静脉输注给药后总西罗莫司、总PEG-西罗莫司的药代动力学（PK）特征及代谢产物鉴定研究。探索性目的：1、评价SSS39注射剂在中国健康成年受试者中单次静脉输注给药的免疫原性；2、评价SSS39注射剂在中国健康成年受试者中单次静脉输注给药后游离西罗莫司、游离PEG-西罗莫司、游离PEG的药代动力学（PK）特征；3、评价SSS39注射剂在中国健康成年受试者中单次静脉输注给药对Treg细胞和细胞因子的影响。

[Translation]

Primary objective: To evaluate the safety and tolerability of a single intravenous infusion of SSS39 injection in healthy Chinese adult subjects. Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of total sirolimus and total PEG-sirolimus and metabolite identification of SSS39 injection after a single intravenous infusion in healthy Chinese adult subjects. Exploratory objectives: 1. To evaluate the immunogenicity of a single intravenous infusion of SSS39 injection in healthy Chinese adult subjects; 2. To evaluate the pharmacokinetic (PK) characteristics of free sirolimus, free PEG-sirolimus, and free PEG after a single intravenous infusion of SSS39 injection in healthy Chinese adult subjects; 3. To evaluate the effects of a single intravenous infusion of SSS39 injection on Treg cells and cytokines in healthy Chinese adult subjects.

Start Date08 Oct 2024

Sponsor / Collaborator

Shenyang Sunshine Pharmaceuticals Co., Ltd.

100 Clinical Results associated with SSS39

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100 Translational Medicine associated with SSS39

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100 Patents (Medical) associated with SSS39

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100 Deals associated with SSS39

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