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New treatment option for Healthy Subjects
Official title First-into-human Study of NS-136 in Healthy Subjects
ClinicalTrials.gov ID: NCT06345703
What this study is testing
What is NS-136 tablet?
NS-136 tablet is an investigational medicine, being studied as a potential treatment for healthy subjects.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Study people must meet all of the following criteria for study entry:
- 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...
- For women of reproductive potential, a negative pregnancy test is required, and they must agree to use contraception (more details see Appendix 1)...
- In good health, determined by the investigator on the basis of medical history, physical examinations, vital signs, 12-lead electrocardiograms...
You likely can't join if
- people who meet any of the following criteria will be excluded from study entry:
- 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)...
- Average daily smoking of more than 5 cigarettes in the 3 months prior to screening, or inability to stop using any tobacco products (including...
- Excessive alcohol consumption or weekly alcohol intake exceeding 14 units of alcohol in the 4 weeks prior to screening (1 unit equals 10 grams of...
See the full eligibility criteria
- Study people must meet all of the following criteria for study entry:
- 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...
- 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...
- Full understanding of the purpose, nature, procedures of the study, and the potential adverse reactions. Subject voluntarily participates and signs the informed consent form before any study procedures begin.
- people who meet any of the following criteria will be excluded from study entry:
- 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;
- Excessive alcohol consumption or weekly alcohol intake exceeding 14 units of alcohol in the 4 weeks prior to screening (1 unit equals 10 grams of pure alcohol, alcohol content of different alcoholic beverages is...
- Excessive intake of tea, coffee, or caffeinated beverages (more than 8 cups/day, 1 cup = 250 mL) in the 3 months prior to screening, or inability to stop consuming any beverages or foods containing caffeine, any...
- History of drug abuse within the past year prior to the first dose, or positive results in a multi-drug urine screening test upon screening period and admission. Repeated test is allowed once at investigator discretion;
- History of definite neurological or psychiatric disorders (including epilepsy, migraines, dementia, depression or bipolar disorder, schizophrenia, etc.); history of prolonged QTc interval; immunodeficiency or...
- Underwent major surgery within the past 6 months prior to the first dose (such as coronary artery bypass grafting, hepatectomy, gynecological surgery, etc.); occurrence of acute neurological, digestive, respiratory...
- Donated blood or experienced blood loss ≥400 mL within the 3 months prior to the first dose; difficulties in venous blood collection; planned blood donation during the study or within 1 month after the study;
- Use of strong inhibitors or inducers of cytochrome P450 (CYP) 3A4 within 14 days prior to the administration of the investigational drug or anticipated use of strong CYP3A4 inhibitors or inducers during the study...
- Use of any prescription or non-prescription medications, including herbal and OTC medications within 14 days of dosing, with the exception of paracetamol (≤2 g per day);
- Receipt of vaccines within the 4 weeks prior to the first dose of the investigational product;
- Cannot tolerate high-fat meals or have special dietary requirements, or cannot adhere to a standardized diet (only for people in the FE trial);
- Other factors deemed unsuitable for participation in the trial by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Adelaide, South Australia, Australia
- Chengdu, Sichuan, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Adelaide, South Australia, Australia; Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.