NCT07815210
Phase I Trial of HHK101 in Patients With Schizophrenia
StatusNot Yet Recruiting
PhasePhase 1
Primary completion (estimated)
At risk: Enrollment reduced 30%.
See at-risk trials from Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.
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Record History
All 3 versions: 3 with changes below.
- Minor Trial sites expanded: 0 → 4 locations
- Notable Start date pushed from Sep 30, 2026 to Nov 15, 2026
- Enrollment reduced: 125 → 88 participants
- Interventions modified
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Number of participants with Adverse events
Timeframe: Baseline through 18 weeks post-dose
Drug Concentrations
Timeframe: Baseline through 18 weeks post-dose
Changes from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Timeframe: Baseline through 18 weeks post-dose
Arms and interventions
HHK101 Single Dose 1Experimental
HHK101 Single Dose 2Experimental
HHK101 Single Dose 3Experimental
HHK101 Single Dose 4Experimental
HHK101 Single Dose 5Experimental
HHK101 Multiple Dose 1Experimental
HHK101 Multiple Dose 2Experimental
HHK101 Multiple Dose 3Experimental
Drugs: HHK101-Single Dose 1, HHK101-Single Dose 2, HHK101-Single Dose 3, HHK101-Single Dose 4, HHK101-Single Dose 5, HHK101-Multiple Dose 1, HHK101-Multiple Dose 2, HHK101-Multiple Dose 3
Sites
4 sites in 1 country