A Study of Safety, Tolerability, and Pharmacokinetics of Single Ascending Dosed of HSK31858 in Healthy Volunteers

NCT05023525 | Completed Phase 1 DMC

• 1 other identifier: HSK31858-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I, single-dose escalation clinical trial for HSK31858 conducted in healthy volunteers. The safety, tolerability, and pharmacokinetics of HSK31858 tablet in healthy volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial design.

Conditions

Healthy

Keywords

HSK31858; NCFBE; health; phase I

Outcome Measures

Primary Outcomes (1)

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

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

  7 days after dosing

Secondary Outcomes (6)

• Cmax

  within 15 minutes before administration until 72 hours after administration

• Tmax

  within 15 minutes before administration until 72 hours after administration

• AUC0-last

  within 15 minutes before administration until until 72 hours after administration

• t½

  within 15 minutes before administration until 72 hours after administration

• CL/F

  within 15 minutes before administration until 72 hours after administration

Study Arms (2)

HSK31858, single dose

EXPERIMENTAL

5 cohorts with single doses starting with 5 mg HSK31858 as tablet.

Drug: HSK31858, tablet

Placebe, single dose

PLACEBO COMPARATOR

5 cohorts with matching placebo to HSK31858 as tablet.

Drug: Placebo, tablet

Interventions

HSK31858, tablet DRUG

Starting dose in single ascending dose: 5 mg

HSK31858, single dose

Placebo, tablet DRUG

Matching placebo

Placebe, single dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 55 years of age (inclusive) at Screening.
• Body mass index ≥ 18.0 and ≤ 30.0 kg/m2, with a body weight ≥ 50 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 1, including:
• Physical examination without any clinically relevant findings.
• Systolic blood pressure in the range of 90 to 140 mmHg and diastolic blood pressure in the range of 50 to 90 mmHg after 5 minutes in supine position.
• Heart rate in the range of 50 to 100 bpm after 5 minutes rest in supine position.
• Body temperature, between 35.0°C and 37.7°C.
• No clinically significant findings in serum chemistry, hematology, coagulation, and urinalysis tests as deemed by the Investigator.
• 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, including:
• Normal sinus rhythm with HR between 50 and 100 bpm, inclusive.
• QT interval corrected using the Fridericia method (QTcF) between 350 to 450 msec for male subjects and 350 to 470 msec for female subjects, inclusive.
• QRS duration of \< 120 msec.
• PR interval of ≤ 210 msec.

You may not qualify if:

• 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.
• A primary diagnosis of chronic obstructive pulmonary disease or asthma as deemed by Investigator.
• Subjects has increased risk of infection:
• History and/or presence of tuberculosis (TB).
• Body temperature of \> 37.7℃.
• Blood neutrophil count \<1.7 × 109/L, or white blood cell count \< 4.0×109/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.
• Volunteers who have received live or live-attenuated vaccine in the 4 weeks prior to dosing.
• High-sensitivity C-reactive protein \> upper limit of normal (ULN) at Screening and on Day -1.
• Some subjects lacking functional Dipeptidyl peptidase 1 (DPP1) enzyme have been described to have periodontitis and palmoplantar hyperkeratosis:
• Subjects with signs of current gingivitis/periodontitis. Gingival evaluation (by inspection) will be performed by a dental hygienist or trained study physician.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead
• Haisco Pharmaceutical(Australia) Pty Ltd.: collaborator

Study Sites (1)

Nucleus Network Pty Ltd

Melbourne, Australia

Location

MeSH Terms

Interventions

Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Ofer Gonen

  Nucleus Network Pty Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 26, 2021
• Study Start: October 28, 2021
• Primary Completion: April 19, 2022
• Study Completion: August 16, 2022
• Last Updated: September 6, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)