A Phase 1 interventional study of JX11502MA and Placebo in Schizophrenia, sponsored by Zhejiang Jingxin Pharmaceutical Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-10.
Sponsored by Zhejiang Jingxin Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment
The purpose of this study is to investigate the safety, tolerability and pharmacokinetic characteristics of JX11502MA capsule on healthy human, and to explore the relationship between the dose, pharmacokinetic parameters and safety of JX11502MA capsule,so as to provide basis for the follow-up clinical trials (multi-dose tolerability, pharmacokinetics and phase II trial, etc.).
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's planned enrollment of 58 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Zhejiang Jingxin Pharmaceutical Co., Ltd. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received JX11502MA capsule 0.25mg、0.5mg、1mg、2mg、3mg、6mg、8mg orally administration once, once on an empty stomach in the morning, with about 240ml of warm water.
Drug: JX11502MA
Participants received placebo capsule 0.25mg、0.5mg、1mg、2mg、3mg、6mg、8mg orally administration once, once on an empty stomach in the morning, with about 240ml of warm water..
Drug: Placebo
Oral capsule
Oral capsule
The incidence rate of adverse reactions
Count the number of subjects with adverse reactions during the trial and calculate the incidence of adverse reactions(Number of subjects with adverse reactions / total number of subjects\* 100%).The adverse reactions include drowsiness、weakness hiccup、vomit、anorexia、nausea、insomnia、dry mouth、dizzy and stomach distention
Time frame: Day(1)-Day(7)
Cmax
Maximum Serum Concentration of the parent drug
Time frame: Day(1)-Day(7)
Tmax
Time to Reach the Maximum Serum Concentration of the parent drug
Time frame: Day(1)-Day(7)
AUC
Area Under the Serum Concentration-Time Curve of the parent drug
Time frame: Day(1)-Day(7)
t1/2
Elimination half-life period
Time frame: Day(1)-Day(7)
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Zhejiang Jingxin Pharmaceutical Co., Ltd.