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AzTrials

Healthy VolunteersPhase 1NCT05663593

Safety, Tolerability,PK/PD, Food Effect of Single and Multiple Ascending Doses of HSK31858 in Healthy Volunteers

A Phase 1 study testing HSK31858, tablet in people with Healthy Volunteers, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
HSK31858, tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
74 participants
Where
1 siteChina
Study dates
23 Feb 2022to 30 Nov 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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 1.
  • 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.

Who cannot join

  • 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.
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  • 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.
  • 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.
  • Subjects with a history of hyperkeratosis or erythema in palms or soles.
  • Liver function test results (i.e., aspartate aminotransferase [AST], alanine aminotransferase [ALT], and gamma glutamyl transferase [GGT]) and total bilirubin elevated more than 1.5 fold above the ULN.
  • Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody and human immunodeficiency virus (HIV) antibody test are positive at screening.
  • Presence or having sequelae of gastrointestinal, liver, kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
  • History of alcohol abuse within 12 months prior to first study drug administration or positive alcohol breath test. Regular alcohol consumption defined as > 21 alcohol units per week (where 1 unit = 284 mL of beer, 25 mL of 40% spirit or a 125 mL glass of wine).
  • Use of any prescription or over-the-counter medication (including herbal products, diet aids, and hormone supplements) within 14 days or 5 half-lives of the medication (whichever is longer) prior to the first study drug administration, except occasional use of paracetamol. Use of any IP or investigational medical device within 30 days prior to Screening, or 5 half-lives of the product (whichever is the longest).
  • Donation of blood or plasma within 30 days prior to first study drug administration, or loss of whole blood of more than 500 mL within 30 days prior to randomization, or receipt of a blood transfusion within 1 year of first study drug administration.
  • Participation in another investigational clinical trial within 60 days prior to the first study drug administration.
  • 19. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the Follow-up period.

Trial locations and contacts

1 site in 1 country.

China1 site

  • PKUCare Luzhong Hospital

    Zibo, Shang Dong, 255400

Other trials in China

About this study

Official title: 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

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

Being tested
HSK31858, tablet, Placebo, tablet
Keywords
HSK31858, NCFBE, phase I

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HSK31858, tabletDrug

    Starting dose in single ascending dose: 5 mg

  • Placebo, tabletDrug

    Matching placebo

Study groups in NCT05663593
Study groupRoleWhat they receive
HSK31858ExperimentalSingle or multiple oral doses of HSK31858 Tablet, orally once daily
Receives: Drug: HSK31858, tablet
PlaceboPlacebo comparatorMatching placebo Tablet, orally once daily
Receives: Drug: Placebo, tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 volunteers

    Measured: 7 days after single dose

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

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

    Measured: 56 days after multiple dose

Secondary outcomes (5)

  1. Cmax

    Maximum concentration

    Measured: within 30 minutes before administration until 72 hours after administration

  2. Tmax

    Time to maximum concentration

    Measured: within 30 minutes before administration until 72 hours after administration

  3. AUC0-last

    Area under the drug concentration-time curve, from time 0h to 72h

    Measured: within 30 minutes before administration until until 72 hours after administration

  4. t½

    Apparent terminal half-life

    Measured: within 30 minutes before administration until 72 hours after administration

  5. Absolute neutrophil count (ANC) normalized relative neutrophil elastase (NE) Activity

    Assessed NE activity changes in multiple doses

    Measured: within 30 minutes before administration until until 56 days after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2022
  2. Study start23 Feb 2022
  3. Primary completion15 Aug 2022
  4. Study completion30 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05663593
Sponsor's protocol ID
HSK31858-102
Status last verified
Sep 2022
First submitted
6 Dec 2022
Last updated
23 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang Y, Yu C, Hu M, Wang L, Chen M, Liu H, Wu N, Hou J. Safety, tolerability, pharmacokinetics and pharmacodynamics of HSK31858, a novel oral dipeptidyl peptidase-1 inhibitor, in healthy volunteers: An integrated phase 1, randomized, double-blind, placebo-controlled, single- and multiple-ascending dose study. Br J Clin Pharmacol. 2025 Aug;91(8):2262-2272. doi: 10.1002/bcp.70027. Epub 2025 Apr 2.

    PubMed 40170587

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HSK31858, tablet in people with Healthy Volunteers, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number and severity of treatment emergent adverse events (TEAEs) (time frame: 7 days after single dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05663593, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.

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