Zhejing Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
NCT Number: NCT04229433
The study is a randomized, single-blind, placebo-controlled, multiple-dose escalation Phase I trials. 2 dose groups were designed, 12 subjects in each dose group.The drug was administered single dose and multiple doses.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Hangzhou, Zhejiang, 310014, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exclusion criteria
8.3 months prior to screening involved in any drug or medical device clinical studies or within 5 half-life of drugs before screening.
9.Female subjects who did not receive contraception at least 30 days before administration.
Pharmaceutical form: SHR2285 tablet Route of administration: single dose and multiple doses.
Pharmaceutical form: Placebo tablet Route of administration: single dose and multiple doses.
Time frame: Pre-dose to 7 days after multiple dose administration.
Time frame: Pre-dose to 3 days after single dose administration
Area under the plasma concentration versus time curve (AUC) for single dose of SHR2285.
Time frame: Pre-dose to 3 days after single dose administration
Time frame: Pre-dose to 3 days after single dose administration
Time frame: Pre-dose to 3 days after single dose administration.
Time frame: Pre-dose to 3 days after single dose administration.
Time frame: Pre-dose to 3 days after single dose administration
Time frame: Pre-dose to 2 days after multiple dose administration
Time frame: Pre-dose to 2 days after multiple dose administration
Time frame: Pre-dose to 2 days after multiple dose administration
Time frame: Pre-dose to 2 days after multiple dose administration.
Time frame: Pre-dose to 2 days after multiple dose administration
Time frame: Pre-dose to 2 days after multiple dose administration.
Time frame: Pre-dose to 2 days after multiple dose administration.
Time frame: Pre-dose to 2 days after multiple dose administration.
Time frame: Pre-dose to 2 days after multiple dose administration.
Time frame: Pre-dose to 3 days after single dose administration.
FXI activity; Change of APTT, PT, INR from baseline.
Time frame: Pre-dose to 2 days after multiple dose administration.
FXI activity; Change of APTT, PT, INR from baseline.
Jiangsu HengRui Medicine Co., Ltd.
Industry
A Phase I, Randomized, Single -Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR2285 Tablets in Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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