Jiangnan University Affiliated Hospital
Wuxi, China
Location status: Recruiting
NCT Number: NCT06912295
This single-center, randomized, double-blind, placebo-controlled, two-part study is designed to assess the safety, tolerability and PK of oral HL-1186 Tablet in healthy participants.
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Phase 1
Wuxi, China
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HL-1186 tablet for oral administration.
HL-1186 placebo tablet for oral administration.
Time frame: Single ascending dose(SAD): day1 to day14; Food effect(FE): day1 to day21; Multiple ascending dose(MAD): day1 to day27
Number of participants with adverse events, with abnormal physical examination finding, with abnormal vital signs, abnormal 12-lead electrocardiograms and abnormal laboratory tests results (hematology, urinalysis, clinical chemistry, coagulation function
Time frame: Single ascending dose(SAD): day1 to day7; Food effect(FE): day1 to day14; Multiple ascending dose(MAD): day1 to day20
Time to reach maximum concentration (Tmax)
Time frame: Single ascending dose(SAD): day1 to day7; Food effect(FE): day1 to day14; Multiple ascending dose(MAD): day1 to day20
Maximum concentration (Cmax)
Time frame: Single ascending dose(SAD): day1 to day7; Food effect(FE): day1 to day14; Multiple ascending dose(MAD): day1 to day20
Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration (AUC0-t)
Time frame: Single ascending dose(SAD): day1 to day7; Food effect(FE): day1 to day14; Multiple ascending dose(MAD): day1 to day20
Elimination half time (T1/2)
Contact information is provided by the study sponsor or research team.
Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
Industry
A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of HL-1186 in Healthy Participants
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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