Actively Recruiting
First-into-human Study of NS-136 in Healthy Subjects
Led by NeuShen Therapeutics · Updated on 2024-11-19
76
Participants Needed
2
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
First-into-human Study of NS-136 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy males or females aged 18-65 years with a BMI between 18.00 and 32.00 kg/m2
- No participation in other clinical trials within 30 days or 5 half-lives of investigational drugs prior to screening
- Negative pregnancy test for women of reproductive potential and agreement to use contraception until 90 days after last dose
- Agreement from male subjects to use contraception and prohibition of sperm or ova donation during the study
- Good health confirmed by medical history, physical exam, vital signs, ECG, and laboratory tests
- Understanding of the study purpose and voluntary signing of informed consent
You will not qualify if you...
- Allergic to investigational product or its components
- Intolerance to venipuncture, blood fainting, or needle phobia
- Positive for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody at screening
- Smoking more than 5 cigarettes daily in the past 3 months or inability to stop tobacco use during trial
- Excessive alcohol consumption or unwillingness to stop alcohol during the trial
- Excessive intake of caffeine or inability to stop consuming caffeine, purine-rich foods, or grapefruit during trial
- History of drug abuse within the past year or positive multi-drug urine test at screening
- History of neurological or psychiatric disorders, prolonged QTc interval, immunodeficiency, cancer, or chronic major diseases
- Major surgery within 6 months prior to dosing or acute diseases affecting drug safety within 3 months
- Blood donation or loss of 400 mL or more within 3 months prior to dosing, planned blood donation during or shortly after study
- Use of strong CYP3A4 inhibitors or inducers within 14 days prior to dosing or anticipated during study
- Use of any medications within 14 days of dosing except paracetamol up to 2 g per day
- Vaccination within 4 weeks prior to dosing
- Inability to tolerate high-fat meals or adhere to standardized diet (for food effect trial)
- Other factors judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, Australia, 5000
Actively Recruiting
2
Chengdu Xinhua Hospital
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
C
Chao Zhang, PhD
CONTACT
Y
Yangyi Qu, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
14
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