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

Healthy Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04986436
• Other study ID #: HS-10360-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: July 2021
• Est. completion date: June 2022

Study information

• Verified date: June 2021
• Source: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Contact: Qing He, bachelor
• Phone: 0510-85350951
• Email: heqing0510[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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;

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• HS-10360
Single or multiple dose(s) of HS-10360
• Placebo
Single or multiple dose(s) of Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Electrocardiogram	Number of participants who experienced a clinically significant electrocardiogram (ECG) result	Baseline to end of follow-up (a maximum of 42 days)
Primary	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	SAD pharmacokinetic endpoints:	The maximum plasma concentration (Cmax)	Day1-Day6
Secondary	SAD pharmacokinetic endpoints:	Time to Cmax (Tmax)	Day1-Day6
Secondary	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
Secondary	SAD pharmacokinetic endpoints:	The area under the plasma concentration-time curve from time zero xtrapolated to infinite time (AUC0-8)	Day1-Day6
Secondary	SAD pharmacokinetic endpoints:	Terminal rate constant (?z)	Day1-Day6
Secondary	SAD pharmacokinetic endpoints:	Half life (t½)	Day1-Day6
Secondary	SAD pharmacokinetic endpoints:	Apparent clearance following oral administration (CL/F)	Day1-Day6
Secondary	SAD pharmacokinetic endpoints:	Apparent volume of distribution following oral administration (Vz/F)	Day1-Day6
Secondary	SAD pharmacokinetic endpoints:	Mean residence time (MRT)	Day1-Day6
Secondary	SAD pharmacokinetic endpoints:	Amount excreted in urine (Aeu)	Day1-Day6(SAD)
Secondary	SAD pharmacokinetic endpoints:	Amount excreted in feces (Aef)	Day1-Day6(SAD)
Secondary	MAD pharmacokinetic endpoints:	The maximum steady state drug concentration in plasma during dosing interval (Css,max)	Day1-Day19
Secondary	MAD pharmacokinetic endpoints:	The minimum steady state drug concentration in plasma during dosing interval (Css,min)	Day1-Day19
Secondary	MAD pharmacokinetic endpoints:	Average steady state drug concentration in plasma during dosing interval Css,av)	Day1-Day19
Secondary	MAD pharmacokinetic endpoints:	Time to Css, max (Tss,max)	Day1-Day19
Secondary	MAD pharmacokinetic endpoints:	The area under the plasma concentration-time curve over the dosing interval at steady state (AUCss)	Day1-Day19
Secondary	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
Secondary	MAD pharmacokinetic endpoints:	The area under the plasma concentration-time curve from time zero xtrapolated to infinite time (AUC0-8) at steady state	Day1-Day19
Secondary	MAD pharmacokinetic endpoints:	Half life (t½)	Day1-Day19
Secondary	MAD pharmacokinetic endpoints:	Accumulation ratio (Rac)	Day1-Day19
Secondary	MAD pharmacokinetic endpoints:	Apparent clearance at steady state following oral administration (CLss/F)	Day1-Day19
Secondary	MAD pharmacokinetic endpoints:	Apparent volume of distribution at steady state following oral administration (Vd/F)	Day1-Day19
Secondary	MAD pharmacokinetic endpoints:	Amount excreted in urine (Aeu)	Day1-Day19
Secondary	MAD pharmacokinetic endpoints:	Amount excreted in feces (Aef)	Day1-Day19