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

NCT04986436 | Unknown Phase 1

• 1 other identifier: HS-10360-101
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

HS-10360; Safety; Pharmacokinetics

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (24)

• SAD pharmacokinetic endpoints:

  Day1-Day6

• SAD pharmacokinetic endpoints:

  Day1-Day6

• SAD pharmacokinetic endpoints:

  Day1-Day6

• SAD pharmacokinetic endpoints:

  Day1-Day6

• SAD pharmacokinetic endpoints:

  Day1-Day6

Study Arms (2)

HS-10360

EXPERIMENTAL

Either single or multiple doses of varying dose levels

Drug: HS-10360

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HS-10360 DRUG

Single or multiple dose(s) of HS-10360

HS-10360

Placebo DRUG

Single or multiple dose(s) of Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Officials

• Qing He, bachelor

  Wu Xi people's hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qing He, bachelor

CONTACT

0510-85350951; heqing0510@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: August 2, 2021
• Study Start: July 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: August 2, 2021

Record last verified: 2021-06