[Translation] Phase I clinical study on the safety, tolerability, pharmacokinetics and food effects of single and multiple doses of UA021 capsules in healthy adult subjects

1、主要目的 1）评估健康成人单次服用UA021胶囊后的安全性和耐受性。 2）评估健康成人多次服用UA021胶囊后的安全性和耐受性。 2、次要目的 1）评估健康成人单次和多次服用UA021胶囊后的药代动力学特征。 2）评估食物对健康成人服用UA021胶囊后的药代动力学特征的影响。

[Translation]

1. Primary objectives 1) To evaluate the safety and tolerability of UA021 capsules after a single dose in healthy adults. 2) To evaluate the safety and tolerability of UA021 capsules after multiple doses in healthy adults. 2. Secondary objectives 1) To evaluate the pharmacokinetic characteristics of UA021 capsules after single and multiple doses in healthy adults. 2) To evaluate the effect of food on the pharmacokinetic characteristics of UA021 capsules after taking them in healthy adults.

Start Date16 May 2023

Sponsor / Collaborator

Yousen Jianheng Biomedical (Shanghai) Co., Ltd.

ACTRN12622001349730

/ SuspendedPhase 1

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single- and Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UA021 in Healthy Participants

Start Date19 Dec 2022

Sponsor / Collaborator

Emerald Clinical Trials Pty Ltd.

CTR20253729

/ Not yet recruitingPhase 2

评价UA021治疗中重度斑块状银屑病的有效性和安全性的多中心、随机、双盲、安慰剂平行对照的Ⅱ期临床研究

[Translation] A multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of UA021 in the treatment of moderate to severe plaque psoriasis

主要目的：评估UA021不同剂量组治疗中重度银屑病的有效性。次要目的：评估UA021不同剂量组治疗中重度银屑病的安全性；评估UA021不同剂量组在疗中重度银屑病患者中的药代动力学（PK）特征。

[Translation]

Primary Objective: To evaluate the efficacy of different doses of UA021 in the treatment of moderate to severe psoriasis. Secondary Objective: To evaluate the safety of different doses of UA021 in the treatment of moderate to severe psoriasis; and to evaluate the pharmacokinetic (PK) characteristics of different doses of UA021 in patients with moderate to severe psoriasis.

Start Date-

Sponsor / Collaborator

Yousen Jianheng Biomedical (Shanghai) Co., Ltd.

100 Clinical Results associated with UA021

100 Translational Medicine associated with UA021

100 Patents (Medical) associated with UA021

100 Deals associated with UA021

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Plaque psoriasis	Phase 2	China	Yousen Jianheng Biomedical (Shanghai) Co., Ltd.	24 Sep 2025
Inflammatory Bowel Diseases	IND Approval	China	Yousen Jianheng Biomedical (Shanghai) Co., Ltd.	21 Oct 2022
Systemic Lupus Erythematosus	IND Approval	China	Yousen Jianheng Biomedical (Shanghai) Co., Ltd.	21 Oct 2022

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