Phase 1a Study in Healthy Participants

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of HS-10506 in Healthy Subjects

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

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: HS-10506; Drug: HS-10506 Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Huafang Li; Phone Number: 021-34773128; Email: lhlh_5@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: HS-10506; HS-10506 will be administered orally once on Day 1.
Experimental: 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.	Drug: HS-10506 Placebo; Matching placebo will be administered orally once on Day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Screening until Trail phase (up to 5 weeks)
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	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.	From baseline to Day 3
Change in Stanford Sleepiness Scale score from before to 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.	From baseline to 4 hours after dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observed maximum plasma concentration (Cmax)	Cmax will be obtained following administration of a single oral dose of HS-10506.	up to 48 hours after dosing
Time to reach maximum plasma concentration (Tmax)	Tmax will be obtained following administration of a single oral dose of HS-10506.	up to 48 hours after dosing
Area under the concentration-time curve from time zero to last time of quantifiable concentration（AUC0-t）	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.	up to 48 hours after dosing
Area under the concentration-time curve from time zero to infinity（AUC0-∞）	AUC0-t will be obtained following administration of a single oral dose of HS-10506.	up to 48 hours after dosing
Terminal Rate Constant（λz）	Terminal Rate Constant（λz） will be obtained following administration of a single oral dose of HS-10506.	up to 48 hours after dosing
Elimination Halflife (T1/2)	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.	up to 48 hours after dosing
Apparent clearance（CL/F）	CL/F will be obtained following administration of a single oral dose of HS-10506.	up to 48 hours after dosing
Apparent Volume of Distribution（Vd/F）	Vd/F will be obtained following administration of a single oral dose of HS-10506. Time Frame: up to 48 hours after dosing	up to 48 hours after dosing
Mean Residence Time(MRT)	RT will be obtained following administration of a single oral dose of HS-10506.	up to 48 hours after dosing

Collaborators and Investigators

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 17, 2023
• Primary Completion (Estimated): December 24, 2023
• Study Completion (Estimated): December 24, 2023

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: HS-10506, Phase 1, Healthy
• Other Study ID Numbers: HS-10506-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No