CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 96 enrolled
Drug / intervention
HS-10353 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05195203
NCT05195203Phase 1Completed
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A Phase I Randomized, Double-blinded, Placebo-controlled Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetic of HS-10353 in Chinese Adult Subjects

Jiangsu Hansoh Pharmaceutical Co., Ltd.·interventional·Posted Jan 18, 2022·Updated Aug 3, 2023

In Brief

A Phase 1 clinical trial evaluating HS-10353 and Placebo for Major Depressive Disorder. Completed, enrolled 96 participants across 1 site.

Detailed Summary

The primary objective of this study is to assess the safety and tolerability of single and multiple oral administered doses of HS-10353 separately in Chinese healthy and major depressive disorder subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedJan 18, 2022
Enrollment StartJan 27, 2021
Primary CompletionMar 11, 2023
Study CompletionMar 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 4.5 years ago

Interventions

HS-10353drug

Single or multiple dose(s) of HS-10353

Placebodrug

Single or multiple dose(s) of placebo