The First Hospital of Jilin University
Changchun, Jilin, 130000, China
NCT Number: NCT05492630
The Safety, Tolerability Pharmacokinetic and Food Effect Study of HEC73077 in Healthy Subjects
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Changchun, Jilin, 130000, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single-Dose Study: Each dose of HEC73077 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
Multiple-dose study:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and/or multiple-dose study.
Single-Dose Study: Each dose of HEC73077 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
Multiple-dose study:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and/or multiple-dose study.
Time frame: Up to 19 days
Incidence of adverse events
Time frame: Day 1-17
Maximum plasma concentration of study drugs
Time frame: Day 1-17
area under the concentration versus time curve (AUC) from time zero to infinity
Sunshine Lake Pharma Co., Ltd.
Industry
A Randomized, Double-Blind, Placebo-Controlled Study of Ascending Single and Multiple Doses to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Randomized, Open-label, Food Effect Study of HEC73077 in Healthy Subjects
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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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