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HealthyPhase 1NCT04986436

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

A Phase 1 study testing HS-10360 in people with Healthy, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
HS-10360
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
No sites listed yet
Study dates
Jul 2021to Jun 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

  • 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;

Who cannot join

  • 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;

Trial locations and contacts

No sites are listed yet.

Qing He, bachelor contact

0510-85350951 ext. +86

heqing0510@163.com

About this study

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.

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.

Read the 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.

Conditions
Healthy
Being tested
HS-10360, Placebo
Keywords
HS-10360; Safety; Pharmacokinetics

What participants receive

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

  • HS-10360Drug

    Single or multiple dose(s) of HS-10360

  • PlaceboDrug

    Single or multiple dose(s) of Placebo

Study groups in NCT04986436
Study groupRoleWhat they receive
HS-10360ExperimentalEither single or multiple doses of varying dose levels
Receives: Drug: HS-10360
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Treatment-emergent adverse events (TEAE)

    Number of participants who experience one or more treatment-emergent adverse events (TEAE)

    Measured: Baseline to end of follow-up (a maximum of 42 days)

  2. Moderate or severe treatment-emergent adverse events (TEAE)

    Number of participants who experience one or more moderate or severe treatment-emergent adverse events (TEAE)

    Measured: Baseline to end of follow-up (a maximum of 42 days)

  3. Serious treatment-emergent adverse events (TEAE)

    Number of participants who experience one or more serious treatment-emergent adverse events (TEAE)

    Measured: Baseline to end of follow-up (a maximum of 42 days)

  4. Clinical laboratory measurements

    Number of participants who experienced a clinically significant clinical laboratory measurements

    Measured: Baseline to end of follow-up (a maximum of 42 days)

  5. Electrocardiogram

    Number of participants who experienced a clinically significant electrocardiogram (ECG) result

    Measured: Baseline to end of follow-up (a maximum of 42 days)

  6. Vital Signs

    Number of participants who experienced a clinically significant vital sign measurement

    Measured: Baseline to end of follow-up (a maximum of 42 days)

Secondary outcomes (24)

  1. SAD pharmacokinetic endpoints:

    The maximum plasma concentration (Cmax)

    Measured: Day1-Day6

  2. SAD pharmacokinetic endpoints:

    Time to Cmax (Tmax)

    Measured: Day1-Day6

  3. SAD pharmacokinetic endpoints:

    The area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUC0-t)

    Measured: Day1-Day6

  4. SAD pharmacokinetic endpoints:

    The area under the plasma concentration-time curve from time zero xtrapolated to infinite time (AUC0-∞)

    Measured: Day1-Day6

  5. SAD pharmacokinetic endpoints:

    Terminal rate constant (λz)

    Measured: Day1-Day6

  6. SAD pharmacokinetic endpoints:

    Half life (t½)

    Measured: Day1-Day6

  7. SAD pharmacokinetic endpoints:

    Apparent clearance following oral administration (CL/F)

    Measured: Day1-Day6

  8. SAD pharmacokinetic endpoints:

    Apparent volume of distribution following oral administration (Vz/F)

    Measured: Day1-Day6

  9. SAD pharmacokinetic endpoints:

    Mean residence time (MRT)

    Measured: Day1-Day6

  10. SAD pharmacokinetic endpoints:

    Amount excreted in urine (Aeu)

    Measured: Day1-Day6(SAD)

  11. SAD pharmacokinetic endpoints:

    Amount excreted in feces (Aef)

    Measured: Day1-Day6(SAD)

  12. MAD pharmacokinetic endpoints:

    The maximum steady state drug concentration in plasma during dosing interval (Css,max)

    Measured: Day1-Day19

  13. MAD pharmacokinetic endpoints:

    The minimum steady state drug concentration in plasma during dosing interval (Css,min)

    Measured: Day1-Day19

  14. MAD pharmacokinetic endpoints:

    Average steady state drug concentration in plasma during dosing interval Css,av)

    Measured: Day1-Day19

  15. MAD pharmacokinetic endpoints:

    Time to Css, max (Tss,max)

    Measured: Day1-Day19

  16. MAD pharmacokinetic endpoints:

    The area under the plasma concentration-time curve over the dosing interval at steady state (AUCss)

    Measured: Day1-Day19

  17. MAD pharmacokinetic endpoints:

    The area under the plasma concentration-time curve from time zero to the time of the last measurable concentration at steady state(AUC0-t)

    Measured: Day1-Day19

  18. MAD pharmacokinetic endpoints:

    The area under the plasma concentration-time curve from time zero xtrapolated to infinite time (AUC0-∞) at steady state

    Measured: Day1-Day19

  19. MAD pharmacokinetic endpoints:

    Half life (t½)

    Measured: Day1-Day19

  20. MAD pharmacokinetic endpoints:

    Accumulation ratio (Rac)

    Measured: Day1-Day19

  21. MAD pharmacokinetic endpoints:

    Apparent clearance at steady state following oral administration (CLss/F)

    Measured: Day1-Day19

  22. MAD pharmacokinetic endpoints:

    Apparent volume of distribution at steady state following oral administration (Vd/F)

    Measured: Day1-Day19

  23. MAD pharmacokinetic endpoints:

    Amount excreted in urine (Aeu)

    Measured: Day1-Day19

  24. MAD pharmacokinetic endpoints:

    Amount excreted in feces (Aef)

    Measured: Day1-Day19

Timeline

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

  1. First posted2 Aug 2021
  2. Study startJul 2021 (estimated)
  3. Primary completionJun 2022 (estimated)
  4. Study completionJun 2022 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04986436
Sponsor's protocol ID
HS-10360-101
Status last verified
Jun 2021
First submitted
6 Jul 2021
Last updated
2 Aug 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS-10360 in people with Healthy, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..

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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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

Contact Qing He, bachelor (0510-85350951 ext. +86, heqing0510@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-emergent adverse events (TEAE) (time frame: Baseline to end of follow-up (a maximum of 42 days)). The study lists 6 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 NCT04986436.

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 2 Aug 2021.

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