A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single/Multiple Oral Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of DC561043 in Chinese Healthy Participants, and a Single-Center, Randomized, Open-Label, Crossover Food-Effect Study

Start Date18 Jan 2026

Sponsor / Collaborator

Shanghai Institute of Materia Medica Chinese Academy of Sci

[+1]

CTR20255235

/ Not yet recruitingPhase 1IIT

DC561043 片在中国健康参与者中单次/多次口服给药的单中心、随机、双盲、安慰剂对照、剂量递增的安全性、耐受性、药代动力学试验和单中心、随机、开放、交叉的食物影响试验

[Translation] The safety, tolerability, and pharmacokinetic studies of DC561043 tablets in healthy Chinese participants, including single/multiple oral doses, were conducted in a single-center, randomized, double-blind, placebo-controlled, dose-escalation study, as well as a single-center, randomized, open-label, crossover study on the effects of food.

主要目的：评估 DC561043 片在中国健康参与者中单次/多次口服给药及餐后状态下单次口服给药的安全性和耐受性。次要目的：评估 DC561043 片在中国健康参与者中单次/多次口服给药的药代动力学（PK）特征。评估食物对 DC561043 片药代动力学特征的影响。探索性目的：评价 DC561043 片单次/多次给药对中国健康参与者脑电图的影响。评价 DC561043 片单次给药对中国健康参与者 QT/QTc 间期和其它心电图参数（心率 HR、 PR 间期和 QRS 波群时限）的影响。

[Translation]

Primary Objective: To evaluate the safety and tolerability of DC561043 tablets in healthy Chinese participants after single/multiple oral administration and after a meal. Secondary Objective: To evaluate the pharmacokinetic (PK) characteristics of DC561043 tablets after single/multiple oral administration in healthy Chinese participants. To evaluate the effect of food on the pharmacokinetic characteristics of DC561043 tablets. Exploratory Objective: To evaluate the effect of single/multiple administration of DC561043 tablets on electroencephalograms (EEGs) in healthy Chinese participants. To evaluate the effect of a single administration of DC561043 tablets on QT/QTc intervals and other ECG parameters (heart rate, PR interval, and QRS duration) in healthy Chinese participants.

Start Date-

Sponsor / Collaborator

Shanghai Institute of Materia Medica Chinese Academy of Sci

100 Clinical Results associated with DC561043

100 Translational Medicine associated with DC561043

100 Patents (Medical) associated with DC561043

100 Deals associated with DC561043

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Depressive Disorder	Phase 1	China	Shanghai Institute of Materia Medica Chinese Academy of Sci	31 Dec 2025
Cocaine-Related Disorders	IND Approval	China	Shanghai Institute of Materia Medica Chinese Academy of Sci	09 Apr 2026
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