A Phase 1 interventional study of HR071603 and placebo in Depression, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-16.
Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Treatment
The study is being conducted to evaluate the safety and pharmacokinetics of HR071603 in healthy subjects.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 50 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
HR071603,nasal spray,dose escalation.
Drug: HR071603
Placebo, nasal spray
Drug: placebo
HR071603 monotherapy ,nasal spray
Also known as: R-ketamine
placebo,nasal spray
Incidence of Adverse Events (Safety and Tolerability)
Time frame: Pre-dose to Day8
Assessment of PK parameter-Area under drug-time curve (AUC)
Time frame: Pre-dose to Day2
Assessment of PK parameter-peak time (Tmax)
Time frame: Pre-dose to Day2
Assessment of PK parameter-peak concentration (Cmax)
Time frame: Pre-dose to Day2
Assessment of PK parameter-half-life (t1/2)
Time frame: Pre-dose to Day2
Assessment of PK parameter-apparent clearance rate (CL/F)
Time frame: Pre-dose to Day2
Assessment of PK parameter-apparent distribution volume (Vz/F)
Time frame: Pre-dose to Day2
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Jiangsu HengRui Medicine Co., Ltd.