Phase I Study to Evaluate Safety, Tolerability, and Pharmacokinetics of HS-10360 in Healthy Subjects.

A Phase I, Randomized, Double-blinded, Placebo-controlled Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Administered HS-10360 in Healthy Subjects.

The primary objective of this study is to assess the safety and tolerability of single and multiple oral administered doses of HS-10360 in healthy subjects.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: HS-10360; Drug: Placebo

Detailed Description

This is a phase I, randomized, double-blinded, placebo-controlled, single ascending doses (SAD) study followed by multiple ascending doses (MAD) clinical trial to assess the safety, tolerability, and pharmacokinetics of HS-10360 tablet (s) in Chinese healthy adult subjects.

Approximately five sequential dose levels will be evaluated in SAD phase. Two sentinel subjects will be enrolled in the first cohort and minimal 72 hours post-dose safety data will be evaluated before the remaining subjects are enrolled in this cohort. Approximately three sequential dose cohorts (the specific dose levels should be further determined according to the SAD results) will be evaluated in MAD phase. Each subject will receive only one dose regimen in this study. Safety data up to Day12 (±2) in SAD and up to Day28 (±2) in MAD will be reviewed prior to the next dose level. The number of Cohorts in SAD and MAD would be adjusted based on the assessment of SRC.

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Qing He, bachelor; Phone Number: +86 0510-85350951; Email: heqing0510@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
• Healthy male or female subjects between 18 and 45 years old;
• Body weight more than 50.0kg (male) or 45.0kg (female), body mass index (BMI) within the range of 19.0~26.0kg/m2 (both inclusive);
• Subjects and their partners should have no fertility plan, no sperm or ootid donation plan and must use highly effective contraceptive methods (such as abstinence, condom, etc.) from the screening period to 6 months post-trial;
• Additional inclusion criteria apply;

Exclusion Criteria:

• A subject will not be eligible for inclusion in this study if any of the following criteria apply:
• Clinically significant abnormalities in baseline results of laboratory evaluations;
• Subjects has a positive result of any of following virology tests (hepatitis B surface antigen HBsAg, hepatitis B core antibody HBcAb, hepatitis C virus HCV antibody, human immunodeficiency virus HIV antibody, Treponema pallidum antibody TP-Ab) ;
• History or evidence of clinically significant cardiovascular, pulmonary, endocrine, gastrointestinal, psychiatric, neurologic, hematological or metabolic diseases, especially those conditions that interfere with absorption, metabolism and/or excretion of the study drug, determined by the investigator;
• Any previous or current severe infection, such as cellulitis, pneumonia, sepsis etc., requiring hospitalization and/or intravenous antibiotic treatment, within 30 prior to the screening period;
• Have participated in clinical trials of other drugs or medical devices within 3 months or within 5 half-lives of other drugs before screening (if 5 half-lives exceed 3 months);
• History or presence of allergy, especially known allergy to investigational product components or other JAK inhibitors;
• Had taken any medication, including prescription, over-the-counter, herbal, dietary supplements, or vaccines, within the previous 2 weeks; or within the five half-lives of the aforementioned drugs prior to randomization;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Single or multiple dose(s) of Placebo
EXPERIMENTAL: HS-10360; Either single or multiple doses of varying dose levels	Drug: HS-10360; Single or multiple dose(s) of HS-10360

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-emergent adverse events (TEAE)	Number of participants who experience one or more treatment-emergent adverse events (TEAE)	Baseline to end of follow-up (a maximum of 42 days)
Moderate or severe treatment-emergent adverse events (TEAE)	Number of participants who experience one or more moderate or severe treatment-emergent adverse events (TEAE)	Baseline to end of follow-up (a maximum of 42 days)
Serious treatment-emergent adverse events (TEAE)	Number of participants who experience one or more serious treatment-emergent adverse events (TEAE)	Baseline to end of follow-up (a maximum of 42 days)
Clinical laboratory measurements	Number of participants who experienced a clinically significant clinical laboratory measurements	Baseline to end of follow-up (a maximum of 42 days)
Electrocardiogram	Number of participants who experienced a clinically significant electrocardiogram (ECG) result	Baseline to end of follow-up (a maximum of 42 days)
Vital Signs	Number of participants who experienced a clinically significant vital sign measurement	Baseline to end of follow-up (a maximum of 42 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAD pharmacokinetic endpoints:	The maximum plasma concentration (Cmax)	Day1-Day6
SAD pharmacokinetic endpoints:	Time to Cmax (Tmax)	Day1-Day6
SAD pharmacokinetic endpoints:	The area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUC0-t)	Day1-Day6
SAD pharmacokinetic endpoints:	The area under the plasma concentration-time curve from time zero xtrapolated to infinite time (AUC0-∞)	Day1-Day6
SAD pharmacokinetic endpoints:	Terminal rate constant (λz)	Day1-Day6
SAD pharmacokinetic endpoints:	Half life (t½)	Day1-Day6
SAD pharmacokinetic endpoints:	Apparent clearance following oral administration (CL/F)	Day1-Day6
SAD pharmacokinetic endpoints:	Apparent volume of distribution following oral administration (Vz/F)	Day1-Day6
SAD pharmacokinetic endpoints:	Mean residence time (MRT)	Day1-Day6
SAD pharmacokinetic endpoints:	Amount excreted in urine (Aeu)	Day1-Day6(SAD)
SAD pharmacokinetic endpoints:	Amount excreted in feces (Aef)	Day1-Day6(SAD)
MAD pharmacokinetic endpoints:	The maximum steady state drug concentration in plasma during dosing interval (Css,max)	Day1-Day19
MAD pharmacokinetic endpoints:	The minimum steady state drug concentration in plasma during dosing interval (Css,min)	Day1-Day19
MAD pharmacokinetic endpoints:	Average steady state drug concentration in plasma during dosing interval Css,av)	Day1-Day19
MAD pharmacokinetic endpoints:	Time to Css, max (Tss,max)	Day1-Day19
MAD pharmacokinetic endpoints:	The area under the plasma concentration-time curve over the dosing interval at steady state (AUCss)	Day1-Day19
MAD pharmacokinetic endpoints:	The area under the plasma concentration-time curve from time zero to the time of the last measurable concentration at steady state(AUC0-t)	Day1-Day19
MAD pharmacokinetic endpoints:	The area under the plasma concentration-time curve from time zero xtrapolated to infinite time (AUC0-∞) at steady state	Day1-Day19
MAD pharmacokinetic endpoints:	Half life (t½)	Day1-Day19
MAD pharmacokinetic endpoints:	Accumulation ratio (Rac)	Day1-Day19
MAD pharmacokinetic endpoints:	Apparent clearance at steady state following oral administration (CLss/F)	Day1-Day19
MAD pharmacokinetic endpoints:	Apparent volume of distribution at steady state following oral administration (Vd/F)	Day1-Day19
MAD pharmacokinetic endpoints:	Amount excreted in urine (Aeu)	Day1-Day19
MAD pharmacokinetic endpoints:	Amount excreted in feces (Aef)	Day1-Day19

Collaborators and Investigators

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Qing He, bachelor, Wu Xi people's hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2021
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (ACTUAL): August 2, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: HS-10360; Safety; Pharmacokinetics
• Other Study ID Numbers: HS-10360-101

Drug and device information, study documents

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