HS-10582
DrugDrug:HS-10582 Description:Subjects will receive HS-10582 orally as a single and multiple ascending dose.
NCT Number: NCT07777003
This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HS-10582 following single and multiple dose administration to healthy subjects and subjects with Mildly Elevated LDL-C.
This study will consist of two parts: single ascending dose (SAD) and multiple ascending dose (MAD).
Trial opening soon.
Get Notified18 year–55 year
All sexes
Interventional
Phase 1
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drug:HS-10582 Description:Subjects will receive HS-10582 orally as a single and multiple ascending dose.
Drug:Placebo Description:Subjects will receive placebo matching the HS-10582 dose orally as a single and multiple ascending dose.
Time frame: From Screening until 10 days after last dose
The safety and tolerability of HS-10582 following oral administration of single ascending doses and multiple ascending doses will be assessed
Time frame: From baseline until 10 days after last dose
The pharmacodynamics (PD) of HS-10582 by assessment of LDL-C following oral administration of single ascending doses and multiple ascending doses will be assessed
Time frame: From baseline until 120 hours after last dose
Tmax
Time frame: From baseline until 120 hours after last dose
Cmax
Time frame: From baseline until 120 hours after last dose
t1/2
Time frame: From baseline until 120 hours after last dose
AUC
Contact information is provided by the study sponsor or research team.
Fangfang Wang
CONTACT
Haiyan Li, Director of Institution for Dr
CONTACT
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Industry
A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-10582 Tablets After Single and Multiple Oral Doses in Healthy Subjects and Subjects With Mildly Elevated LDL-C
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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