First-into-human Study of NS-136 in Healthy Subjects

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNeuShen Therapeutics

About this trial

The goal of this clinical trial is to exlplore the profile of NS-136 in health conditions. The main questions it aims to answer are:

* Is NS-136 safe and tolerable in heathy subjects under tested dosing regimen? * What is the pharmacokinectic profile of NS-136 in healthy subjects under tested dosing regimen?

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy males or females aged 18-65 years (inclusive), with a body mass index (BMI) between 18.00 and 32.00 kg/m2(inclusive);

Not participated in any other clinical trials within the past 30 days or 5 half-lives of other investigational drugs prior to the screening, whichever is longer;

For women of reproductive potential, a negative pregnancy test is required, and they must agree to use contraception (more details see Appendix 1) from the time of signing the informed consent form until at least 90 days after the last dose of investigational product. Male subjects must agree to use adequate contraception from the time of signing the informed consent form until at least 90 days after the last dose of investigational product, and donation of sperm or ova is prohibited during the entire study period;

In good health, determined by the investigator on the basis of medical history, physical examinations, vital signs, 12-lead electrocardiograms (12-ECGs), clinical laboratory tests (haematology, urinalysis, blood chemistry). Repeated examination is allowed once at investigator's discretion;

Disqualifiers

Individuals who are allergic to the investigational product or any of its components, or who are easily allergic at investigator's discretion;

Individuals who are intolerant to venipuncture/venous catheterization or blood fainting or needle phobia;

Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (Anti-HCV), human immunodeficiency virus antibody (Anti-HIV) during the screening period;

Average daily smoking of more than 5 cigarettes in the 3 months prior to screening, or inability to stop using any tobacco products (including nicotine products) during the trial;

Trial design

Design model

Sequential

Treatments tested in this trial

  • Placebo

    Drug

    NS-136 matching placebo

  • NS-136 tablet

    Drug

    Investigational product NS-136

Treatment groups

76 Participants
are divided into 14 treatment groups

14

Treatment groups

See each treatment group below.

Group A: Arm1Experimental treatment 1 intervention
Group B: Arm2Experimental treatment 1 intervention
Group C: Arm3Experimental treatment 1 intervention
Group D: Arm4Experimental treatment 1 intervention
Group E: Arm5Experimental treatment 1 intervention
Group F: Arm6Experimental treatment 1 intervention
Group G: Arm7Experimental treatment 1 intervention
Group H: Arm8Experimental treatment 1 intervention
Group I: Arm9Placebo comparator 1 intervention
Group J: Arm10Placebo comparator 1 intervention
Group K: Arm11Placebo comparator 1 intervention
Group L: Arm12Placebo comparator 1 intervention
Group M: Arm13Placebo comparator 1 intervention
Group N: Arm14Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Treatment-Related Adverse Events

Time frame
for SAD, day 1-7; for MAD, day 1-26, for FE, day1-14
2

Main pharmacokinetic parameters

Vd/F

Time frame
for SAD, day 1-7; for MAD, day 1-26,
3

Main pharmacokinetic parameters

CL/F

Time frame
for SAD, day 1-7; for MAD, day 1-26,
4

Main pharmacokinetic parameters

t1/2

Time frame
for SAD, day 1-7; for MAD, day 1-26,

Secondary outcomes

Other outcomes

Sponsors and contacts

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