Clinical trial NCT05953506: Phase 1a Study in Healthy Participants
Official title: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of HS-10506 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy
Keywords: HS-10506, Phase 1, Healthy
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-07-20
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral HS-10506 in Chinese Healthy Subjects.

Detailed description: This is a phase 1a, first-in-human, double-blind, placebo-controlled clinical trial. The primary objective is to assess the safety, tolerability and pharmacokinetic of single dose HS-10506 in healthy subjects. The secondary objective is to observed pharmacokinetic parameters and metabolites after single dose of HS-10506.

Eligibility criteria: Inclusion Criteria:

* Healthy participants aged from 18 to 45 years
* Subjects need to fully understand the research content and process, as well as possible adverse reactions, and voluntarily signed Informed Consent Form
* Males' weight ≥ 50kg, females' weight ≥ 45kg, body mass index {BMI, BMI=weight/height 2 (kg/m2)} is controlled within the range of 18\~28 (including the critical value)
* During the study and for 3 months after receiving the last dose of study drug, subjects must agree not to donate sperm or eggs, not to plan to have children, and to use an effective method of contraception

Exclusion Criteria:

* Has a history of chronic or serious disease from neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, skeletal muscle system, metabolic endocrine system, skin disease, blood system, immune system or tumor
* Has taken any drugs, including prescription drugs, over-the-counter drugs, herbal preparations, some health products or inhibitor/inducer of CYP3A4 or CYP3A5, within 2 weeks (or 5 half-lives) before screening and throughout the study period
* Has clinically significant ECG abnormalities, such as QT interval corrected according to Fridericia formula(QTcF), \>450 ms (males), \>470 ms (females)
* Has current manifestation of blood pressure or pulse abnormalities in resting state: such as systolic blood pressure \<90 mmHg or ≥140 mmHg, diastolic blood pressure \<60 mmHg or ≥90 mmHg, pulse \<55 bpm or \>100 bpm

Primary outcomes:
measure: Incidence and severity of adverse events (AEs), serious adverse events (SAEs) and adverse events leading to discontinuation from the study, and their correlation with the investigational drug
timeFrame: Screening until Trail phase (up to 5 weeks)
measure: Number of participants with clinically significant change from baseline in vital signs
timeFrame: From baseline to Day 3
measure: Number of participants with clinically significant abnormalities in physical examination
timeFrame: From baseline to Day 3
measure: Changes in 12-lead electrocardiogram from before to after dosing
timeFrame: From baseline to Day 3
measure: Change in Stanford Sleepiness Scale score from before to after dosing
timeFrame: From baseline to 4 hours after dosing
Secondary outcomes:
measure: Observed maximum plasma concentration (Cmax)
timeFrame: up to 48 hours after dosing
measure: Time to reach maximum plasma concentration (Tmax)
timeFrame: up to 48 hours after dosing
measure: Area under the concentration-time curve from time zero to last time of quantifiable concentration（AUC0-t）
timeFrame: up to 48 hours after dosing
measure: Area under the concentration-time curve from time zero to infinity（AUC0-∞）
timeFrame: up to 48 hours after dosing
measure: Terminal Rate Constant（λz）
timeFrame: up to 48 hours after dosing
measure: Elimination Halflife (T1/2)
timeFrame: up to 48 hours after dosing
measure: Apparent clearance（CL/F）
timeFrame: up to 48 hours after dosing
measure: Apparent Volume of Distribution（Vd/F）
timeFrame: up to 48 hours after dosing
measure: Mean Residence Time(MRT)
timeFrame: up to 48 hours after dosing
Other outcomes:
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