Delving into the Latest Updates on CU-10101 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target-

Mechanism-

Therapeutic Areas

Immune System DiseasesCongenital DisordersSkin and Musculoskeletal Diseases

Active Indication

Mild Atopic DermatitisModerate Atopic DermatitisDermatitis, Atopic

Inactive Indication-

Originator Organization

Cutia Therapeutics (Shanghai) Co., Ltd.

Active Organization

Kedi Biomedical (Wuxi) Co., Ltd.Cutia Therapeutics (Shanghai) Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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[Translation] A randomized, double-blind, vehicle-controlled Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of single and multiple topical administrations of CU-10101 ointment in healthy Chinese participants and participants with mild to moderate atopic dermatitis

主要目的：评价 CU-10101 软膏在成年健康参与者中和成年特应性皮炎参与者中单次、多次局部皮肤涂抹给药的安全性和耐受性。次要目的：评价 CU-10101 软膏在成年健康参与者中和成年特应性皮炎参与者中单次、多次局部皮肤涂抹给药的药代动力学（PK）特征。探索性目的：探索 CU-10101 软膏多次局部皮肤涂抹给药治疗成年特应性皮炎参与者的有效性。

[Translation]

Primary objective: To evaluate the safety and tolerability of CU-10101 ointment in single and multiple topical skin applications in healthy adult participants and in adult participants with atopic dermatitis. Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of CU-10101 ointment in single and multiple topical skin applications in healthy adult participants and in adult participants with atopic dermatitis. Exploratory objective: To explore the effectiveness of CU-10101 ointment in multiple topical skin applications in the treatment of adult participants with atopic dermatitis.

Start Date12 Sep 2024

Sponsor / Collaborator

Kedi Biomedical (Wuxi) Co., Ltd.

100 Clinical Results associated with CU-10101

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100 Translational Medicine associated with CU-10101

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100 Patents (Medical) associated with CU-10101

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100 Deals associated with CU-10101

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Mild Atopic Dermatitis	Phase 1	CN	Kedi Biomedical (Wuxi) Co., Ltd.	12 Sep 2024
Moderate Atopic Dermatitis	Phase 1	CN	Kedi Biomedical (Wuxi) Co., Ltd.	12 Sep 2024
Dermatitis, Atopic	IND Approval	CN	Cutia Therapeutics (Shanghai) Co., Ltd.	20 May 2024