A Randomised, Double-blind, Placebo-controlled, 2-part Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Oral Doses of HSK31858 in Healthy Volunteers

Haisco Pharmaceutical Group Co., Ltd.1 site in 1 country74 target enrollmentFebruary 23, 2022

ConditionsHealthy Volunteers

InterventionsHSK31858, tablet Placebo, tablet

DrugsHSK31858, tablet Placebo, tablet

Overview

Phase: Phase 1
Intervention: HSK31858, tablet
Conditions: Healthy Volunteers
Sponsor: Haisco Pharmaceutical Group Co., Ltd.
Enrollment: 74
Locations: 1
Primary Endpoint: The number and severity of treatment emergent adverse events (TEAEs)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase I, randomised, double-blind placebo-controlled, 2-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of HSK31858 in healthy volunteers

Registry

clinicaltrials.gov

Start Date

February 23, 2022

End Date

November 30, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
•Adult males and females, 18 to 45 years of age (inclusive) at Screening.
•Body mass index ≥ 18.0 and ≤ 28.0 kg/m2, with a body weight ≥ 45 kg at Screening.
•Be nonsmokers (including tobacco, e-cigarettes, and marijuana) for at least 1 month prior to first study drug administration.
•Medically healthy without clinically significant abnormalities at Screening and predose on Day
•Conventional 12-lead ECG recording in triplicate (the mean of triplicate measurements will be used to determine eligibility at Screening and predose on Day 1) consistent with normal cardiac conduction and function.

Exclusion Criteria

•History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or surgery within the past 3 months determined by the PI to be clinically relevant.
•Subjects has increased risk of infection:
•History and/or presence of tuberculosis (TB).
•Body temperature of \> 37.7℃.
•Blood neutrophil count \<1.5 × 109/L, or white blood cell count \<3.5×109/L (Screening and Day -1).
•Is in high risk-group (i.e., men who have had unprotected sex with men, women who have had sex without a condom with men who have sex with men, people who have had sex without a condom with a person who has lived or travelled in Africa, people who inject drugs, people who have had sex without a condom with somebody who has injected drugs, people who have caught another sexually transmitted infection, people who have received a blood transfusion while in Africa, eastern Europe, the countries of the former Soviet Union, Asia or central and southern America) for human immunodeficiency virus (HIV) infection within the last 6 months.
•Other latent or chronic infections (e.g., recurrent sinusitis, genital or ocular herpes, urinary tract infection) or at risk of infection (surgery, trauma, or significant infection) within 3 months of Screening, or history of skin abscesses within 3 months of Screening.
•Clinically significant lower respiratory tract infection not resolved within 4weeks prior to Screening, as determined by the PI.
•Volunteers with active malignancy or neoplastic disease in the previous 5 years other than superficial basal cell carcinoma.
•Disease history suggesting abnormal immune function or use of or plans to use systemic immunosuppressive (e.g., corticosteroids, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g., interferon) during the study or within 4 months prior to the first study drug administration.

Arms & Interventions

HSK31858

Single or multiple oral doses of HSK31858 Tablet, orally once daily

Intervention: HSK31858, tablet

Placebo

Matching placebo Tablet, orally once daily

Intervention: Placebo, tablet

Outcomes

Primary Outcomes

The number and severity of treatment emergent adverse events (TEAEs)

Time Frame: 56 days after multiple dose

To assess the safety and tolerability of multiple oral dose of HSK31858 in healthy volunteers

Secondary Outcomes

Cmax(within 30 minutes before administration until 72 hours after administration)
Tmax(within 30 minutes before administration until 72 hours after administration)
AUC0-last(within 30 minutes before administration until until 72 hours after administration)
t½(within 30 minutes before administration until 72 hours after administration)
Absolute neutrophil count (ANC) normalized relative neutrophil elastase (NE) Activity(within 30 minutes before administration until until 56 days after administration)