Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040, China
NCT Number: NCT06033742
The purpose of this first-in-human study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of HS-10374 in healthy subjects.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Shanghai, Shanghai Municipality, 200040, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single or multiple dosing of HS-10374 orally in a fasting state
Single or multiple dosing of HS-10374-matched placebo orally in a fasting state
Time frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Time frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Clinical laboratory tests include hematology, urinalysis, stool analysis, blood chemistry, coagulation testing, Cystatin C, urine β2-microglobulin, erythrocyte sedimentation rate, C-reactive protein, etc.
Time frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Vital sign measured include blood pressure, pulse rate, temperature, and respiration rate.
Time frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc.
Time frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Maximum plasma concentration
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Time to reach Cmax
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Area under the plasma concentration-time curve
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Terminal half-life
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Apparent clearance
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Apparent volume of distribution
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Accumulation ratio
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Industry
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HS-10374 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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