Clinical trial NCT04986436: Phase I Study to Evaluate Safety, Tolerability, and Pharmacokinetics of HS-10360 in Healthy Subjects.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Keywords: HS-10360; Safety; Pharmacokinetics
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-08-02
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Treatment-emergent adverse events (TEAE)
timeFrame: Baseline to end of follow-up (a maximum of 42 days)
measure: Moderate or severe treatment-emergent adverse events (TEAE)
timeFrame: Baseline to end of follow-up (a maximum of 42 days)
measure: Serious treatment-emergent adverse events (TEAE)
timeFrame: Baseline to end of follow-up (a maximum of 42 days)
measure: Clinical laboratory measurements
timeFrame: Baseline to end of follow-up (a maximum of 42 days)
measure: Electrocardiogram
timeFrame: Baseline to end of follow-up (a maximum of 42 days)
measure: Vital Signs
timeFrame: Baseline to end of follow-up (a maximum of 42 days)
Secondary outcomes:
measure: SAD pharmacokinetic endpoints:
timeFrame: Day1-Day6
measure: SAD pharmacokinetic endpoints:
timeFrame: Day1-Day6
measure: SAD pharmacokinetic endpoints:
timeFrame: Day1-Day6
measure: SAD pharmacokinetic endpoints:
timeFrame: Day1-Day6
measure: SAD pharmacokinetic endpoints:
timeFrame: Day1-Day6
measure: SAD pharmacokinetic endpoints:
timeFrame: Day1-Day6
measure: SAD pharmacokinetic endpoints:
timeFrame: Day1-Day6
measure: SAD pharmacokinetic endpoints:
timeFrame: Day1-Day6
measure: SAD pharmacokinetic endpoints:
timeFrame: Day1-Day6
measure: SAD pharmacokinetic endpoints:
timeFrame: Day1-Day6(SAD)
measure: SAD pharmacokinetic endpoints:
timeFrame: Day1-Day6(SAD)
measure: MAD pharmacokinetic endpoints:
timeFrame: Day1-Day19
measure: MAD pharmacokinetic endpoints:
timeFrame: Day1-Day19
measure: MAD pharmacokinetic endpoints:
timeFrame: Day1-Day19
measure: MAD pharmacokinetic endpoints:
timeFrame: Day1-Day19
measure: MAD pharmacokinetic endpoints:
timeFrame: Day1-Day19
measure: MAD pharmacokinetic endpoints:
timeFrame: Day1-Day19
measure: MAD pharmacokinetic endpoints:
timeFrame: Day1-Day19
measure: MAD pharmacokinetic endpoints:
timeFrame: Day1-Day19
measure: MAD pharmacokinetic endpoints:
timeFrame: Day1-Day19
measure: MAD pharmacokinetic endpoints:
timeFrame: Day1-Day19
measure: MAD pharmacokinetic endpoints:
timeFrame: Day1-Day19
measure: MAD pharmacokinetic endpoints:
timeFrame: Day1-Day19
measure: MAD pharmacokinetic endpoints:
timeFrame: Day1-Day19
Other outcomes:
Locations:
Study officials:
affiliation: Wu Xi people's hospital
name: Qing He, bachelor
role: PRINCIPAL_INVESTIGATOR
References: