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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06345703




Registration number
NCT06345703
Ethics application status
Date submitted
19/03/2024
Date registered
3/04/2024

Titles & IDs
Public title
First-into-human Study of NS-136 in Healthy Subjects
Scientific title
A Phase 1, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and PK of Single and Multiple Ascending Oral Doses and Food Effect of NS-136 in Healthy Subjects
Secondary ID [1] 0 0
CTR20244269
Secondary ID [2] 0 0
NS136HV101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Subjects 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - NS-136 tablet

Experimental: Arm1 - NS-136 SAD Dose 1

Experimental: Arm2 - NS-136 SAD Dose 2

Experimental: Arm3 - NS-136 SAD Dose 3

Experimental: Arm4 - NS-136 SAD Dose 4

Experimental: Arm5 - Arm5 NS-136 MAD Dose 1

Experimental: Arm6 - Arm5 NS-136 MAD Dose 2

Experimental: Arm7 - FE Grp A

Experimental: Arm8 - FE Grp B

Placebo comparator: Arm9 - NS-136 SAD Dose 1 PBO

Placebo comparator: Arm10 - NS-136 SAD Dose 2 PBO

Placebo comparator: Arm11 - NS-136 SAD Dose 3 PBO

Placebo comparator: Arm12 - NS-136 SAD Dose 4 PBO

Placebo comparator: Arm13 - NS-136 MAD Dose 1 PBO

Placebo comparator: Arm14 - NS-136 MAD Dose 2 PBO


Treatment: Drugs: Placebo
NS-136 matching placebo

Treatment: Drugs: NS-136 tablet
Investigational product NS-136
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Treatment-Related Adverse Events
Timepoint [1] 0 0
for SAD, day 1-7; for MAD, day 1-26, for FE, day1-14
Primary outcome [2] 0 0
Main pharmacokinetic parameters
Timepoint [2] 0 0
for SAD, day 1-7; for MAD, day 1-26,
Primary outcome [3] 0 0
Main pharmacokinetic parameters
Timepoint [3] 0 0
for SAD, day 1-7; for MAD, day 1-26,
Primary outcome [4] 0 0
Main pharmacokinetic parameters
Timepoint [4] 0 0
for SAD, day 1-7; for MAD, day 1-26,
Primary outcome [5] 0 0
Main pharmacokinetic parameters
Timepoint [5] 0 0
for SAD, day 1-7; for MAD, day 1-26,
Primary outcome [6] 0 0
Main pharmacokinetic parameters
Timepoint [6] 0 0
for SAD, day 1-7; for MAD, day 1-26,
Primary outcome [7] 0 0
Main pharmacokinetic parameters
Timepoint [7] 0 0
for SAD, day 1-7; for MAD, day 1-26,

Eligibility
Key inclusion criteria
Inclusion Criteria

Study subjects must meet all of the following criteria for study entry:

1. Healthy males or females aged 18-65 years (inclusive), with a body mass index (BMI) between 18.00 and 32.00 kg/m2(inclusive);
2. 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;
3. 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;
4. 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;
5. 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from study entry:

1. Individuals who are allergic to the investigational product or any of its components, or who are easily allergic at investigator's discretion;
2. Individuals who are intolerant to venipuncture/venous catheterization or blood fainting or needle phobia;
3. Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (Anti-HCV), human immunodeficiency virus antibody (Anti-HIV) during the screening period;
4. 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;
5. 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 indicated by volume ratio, approximately 1 alcohol unit is equal to 35 mL of 50° liquor or 350 mL of 5° beer), or unwillingness to stop drinking alcohol or consuming any products containing alcohol during the trial, or positive alcohol test upon screening and admission (repeated test is allowed once at investigator's discretion);
6. 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 beverages or foods rich in purines, or grapefruit and other substances that may affect drug absorption, distribution, metabolism, or excretion during the trial;
7. 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;
8. History of definite neurological or psychiatric disorders (including epilepsy, migraines, dementia, depression or bipolar disorder, schizophrenia, etc.); history of prolonged QTc interval; immunodeficiency or immunosuppressive diseases, malignant neoplastic diseases; chronic cardiovascular, hepatic, renal, endocrine, respiratory, hematological (including coagulation), digestive system diseases, cholecystectomy, Gilbert's Syndrome or resolved childhood asthma;
9. 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, circulatory, endocrine, hematological, or other systemic diseases that may affect the absorption, distribution, metabolism, excretion, and safety evaluation of the investigational product within 3 months prior to screening judged by investigator;
10. 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;
11. 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 participation period;
12. 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);
13. Receipt of vaccines within the 4 weeks prior to the first dose of the investigational product;
14. Cannot tolerate high-fat meals or have special dietary requirements, or cannot adhere to a standardized diet (only for subjects in the FE trial);
15. Other factors deemed unsuitable for participation in the trial by the investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2025
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Sichuan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
NeuShen Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Emir Redzepagic, MD
Address 0 0
CMAX Clinical Research Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Chao Zhang, PhD
Address 0 0
Country 0 0
Phone 0 0
8613918282581
Fax 0 0
Email 0 0
chao.zhang@neushen.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Not decided yet


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06345703