Phase 1a Study in Healthy Participants
- Registration Number
- NCT05953506
- Lead Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 52
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HS-10506 HS-10506 Healthy participants will be enrolled in dose escalation cohorts. Healthy participants will be receive either HS-10506 or matching placebo on Day 1. HS-10506 Placebo HS-10506 Placebo Healthy participants will be enrolled in dose escalation cohorts. Healthy participants will be receive either HS-10506 or matching placebo on Day 1.
- Primary Outcome Measures
Name Time Method Number of participants with clinically significant change from baseline in vital signs From baseline to Day 3 Number of participants with clinically significant abnormalities in physical examination From baseline to Day 3 Changes in 12-lead electrocardiogram from before to after dosing From baseline to Day 3 Descriptive statistics of heart rate, PR interval, QT interval, and QTcF for observed values and changes from baseline will be summarized at each scheduled time point.
Change in Stanford Sleepiness Scale score from before to after dosing From baseline to 4 hours after dosing Stanford Sleepiness Scale（SSS） is a simple and accurate method used to assess sleepiness symptom. Respondents use the scale from 1 to 7 to indicate their current level of sleepiness. Higher scores mean a higher level of sleepiness. Descriptive statistics of SSS scores and changes from baseline will be summarized at each scheduled time point.
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 Screening until Trail phase (up to 5 weeks) The definition of adverse event \[AE\] is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The definition of serious adverse event \[SAE\] is any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect.
- Secondary Outcome Measures
Name Time Method Time to reach maximum plasma concentration (Tmax) up to 48 hours after dosing Tmax will be obtained following administration of a single oral dose of HS-10506.
Area under the concentration-time curve from time zero to last time of quantifiable concentration（AUC0-t） up to 48 hours after dosing Area under the concentration-time curve from time zero to last time of quantifiable concentration（AUC0-t）will be obtained following administration of a single oral dose of HS-10506.
Area under the concentration-time curve from time zero to infinity（AUC0-∞） up to 48 hours after dosing AUC0-t will be obtained following administration of a single oral dose of HS-10506.
Terminal Rate Constant（λz） up to 48 hours after dosing Terminal Rate Constant（λz） will be obtained following administration of a single oral dose of HS-10506.
Elimination Halflife (T1/2) up to 48 hours after dosing Elimination Halflife (T1/2) is the time measured for the concentration to decrease by one half，which will be obtained following administration of a single oral dose of HS-10506.
Apparent clearance（CL/F） up to 48 hours after dosing CL/F will be obtained following administration of a single oral dose of HS-10506.
Apparent Volume of Distribution（Vd/F） up to 48 hours after dosing Vd/F will be obtained following administration of a single oral dose of HS-10506.
Time Frame: up to 48 hours after dosingMean Residence Time(MRT) up to 48 hours after dosing RT will be obtained following administration of a single oral dose of HS-10506.
Observed maximum plasma concentration (Cmax) up to 48 hours after dosing Cmax will be obtained following administration of a single oral dose of HS-10506.