Healthy SubjectsPhase 1NCT06345703
First-into-human Study of NS-136 in Healthy Subjects
A Phase 1 study testing NS-136 tablet in people with Healthy Subjects, run by NeuShen Therapeutics at 2 sites in 2 countries.
Trial summary
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? Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- NS-136 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Apr 2024to Feb 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Study subjects 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 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;
- 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.
Who cannot join
- Subjects 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 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);
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- 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;
- 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 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;
- 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;
- 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 participation period;
- 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 subjects in the FE trial);
- Other factors deemed unsuitable for participation in the trial by the investigator.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Australia1 site, 1 recruiting
- Recruiting
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000
Study Services Director, +61 08 7088 7900, cmax@cmax.com.au
China1 site, 1 recruiting
- Recruiting
Chengdu Xinhua Hospital
Chengdu, Sichuan, 610000
Study Director, 86-02860212019, yongxlan@126.com
About this study
Official 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
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
- Healthy Subjects
- Being tested
- Placebo, NS-136 tablet
- Keywords
- muscarinic m4 receptor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
NS-136 matching placebo
NS-136 tabletDrug
Investigational product NS-136
| Study group | Role | What they receive |
|---|---|---|
| Arm1 | Experimental | NS-136 SAD Dose 1 Receives: Drug: NS-136 tablet |
| Arm2 | Experimental | NS-136 SAD Dose 2 Receives: Drug: NS-136 tablet |
| Arm3 | Experimental | NS-136 SAD Dose 3 Receives: Drug: NS-136 tablet |
| Arm4 | Experimental | NS-136 SAD Dose 4 Receives: Drug: NS-136 tablet |
| Arm5 | Experimental | Arm5 NS-136 MAD Dose 1 Receives: Drug: NS-136 tablet |
| Arm6 | Experimental | Arm5 NS-136 MAD Dose 2 Receives: Drug: NS-136 tablet |
| Arm7 | Experimental | FE Grp A Receives: Drug: NS-136 tablet |
| Arm8 | Experimental | FE Grp B Receives: Drug: NS-136 tablet |
| Arm9 | Placebo comparator | NS-136 SAD Dose 1 PBO Receives: Drug: Placebo |
| Arm10 | Placebo comparator | NS-136 SAD Dose 2 PBO Receives: Drug: Placebo |
| Arm11 | Placebo comparator | NS-136 SAD Dose 3 PBO Receives: Drug: Placebo |
| Arm12 | Placebo comparator | NS-136 SAD Dose 4 PBO Receives: Drug: Placebo |
| Arm13 | Placebo comparator | NS-136 MAD Dose 1 PBO Receives: Drug: Placebo |
| Arm14 | Placebo comparator | NS-136 MAD Dose 2 PBO Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Related Adverse Events
Measured: for SAD, day 1-7; for MAD, day 1-26, for FE, day1-14
Main pharmacokinetic parameters
Vd/F
Measured: for SAD, day 1-7; for MAD, day 1-26,
Main pharmacokinetic parameters
CL/F
Measured: for SAD, day 1-7; for MAD, day 1-26,
Main pharmacokinetic parameters
t1/2
Measured: for SAD, day 1-7; for MAD, day 1-26,
Main pharmacokinetic parameters
Tmax
Measured: for SAD, day 1-7; for MAD, day 1-26,
Main pharmacokinetic parameters
AUC0-∞
Measured: for SAD, day 1-7; for MAD, day 1-26,
Main pharmacokinetic parameters
Cmax
Measured: for SAD, day 1-7; for MAD, day 1-26,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start30 Apr 2024
- Primary completionNov 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- The trial consists of three parts: the first part is a single ascending dose (SAD) study, the second part is a multiple ascending dose (MAD) study, and the third part is food effect (FE) study. The first two parts (SAD and MAD) will be randomized, double-blind, single or multiple ascending dose and placebo-controlled study designs. The third part (FE) will be a randomized, open-label, two-period, crossover study design. To evaluate the safety, tolerability, pharmacokinetic profile, and the effect of food on the PK profile of NS-136 in healthy subjects and to determine the maximum tolerated dose (MTD)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuShen Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emir Redzepagic, MD, Principal investigator, CMAX Clinical Research Pty LtdXiaolan Yong Chief Pharmacist, BS, Principal investigator, Chengdu Xinhua Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345703
- Sponsor's protocol ID
- NS136HV101
- Other IDs
- CTR20244269
- Status last verified
- Nov 2024
- First submitted
- 19 Mar 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided yet
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06345703
- Acronym / sponsor ID
- NS136HV101
- Conditions
- Healthy Subjects
- Keywords
- muscarinic m4 receptor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- NeuShen TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 14
- Model description
- The trial consists of three parts: the first part is a single ascending dose (SAD) study, the second part is a multiple ascending dose (MAD) study, and the third part is food effect (FE) study. The first two parts (SAD and MAD) will be randomized, double-blind, single or multiple ascending dose and placebo-controlled study designs. The third part (FE) will be a randomized, open-label, two-period, crossover study design. To evaluate the safety, tolerability, pharmacokinetic profile, and the effect of food on the PK profile of NS-136 in healthy subjects and to determine the maximum tolerated dose (MTD)
| Arm | Type | Receives |
|---|---|---|
| Arm1 | Experimental | Drug: NS-136 tabletNS-136 SAD Dose 1 |
| Arm2 | Experimental | Drug: NS-136 tabletNS-136 SAD Dose 2 |
| Arm3 | Experimental | Drug: NS-136 tabletNS-136 SAD Dose 3 |
| Arm4 | Experimental | Drug: NS-136 tabletNS-136 SAD Dose 4 |
| Arm5 | Experimental | Drug: NS-136 tabletArm5 NS-136 MAD Dose 1 |
| Arm6 | Experimental | Drug: NS-136 tabletArm5 NS-136 MAD Dose 2 |
| Arm7 | Experimental | Drug: NS-136 tabletFE Grp A |
| Arm8 | Experimental | Drug: NS-136 tabletFE Grp B |
| Arm9 | Placebo comparator | Drug: PlaceboNS-136 SAD Dose 1 PBO |
| Arm10 | Placebo comparator | Drug: PlaceboNS-136 SAD Dose 2 PBO |
| Arm11 | Placebo comparator | Drug: PlaceboNS-136 SAD Dose 3 PBO |
| Arm12 | Placebo comparator | Drug: PlaceboNS-136 SAD Dose 4 PBO |
| Arm13 | Placebo comparator | Drug: PlaceboNS-136 MAD Dose 1 PBO |
| Arm14 | Placebo comparator | Drug: PlaceboNS-136 MAD Dose 2 PBO |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
- 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.
Key exclusion criteria (16 listed)
- 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 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboNS-136 matching placebo | Drug | Arm10, Arm11, Arm12, Arm13, Arm14, Arm9 |
| NS-136 tabletInvestigational product NS-136 | Drug | Arm1, Arm2, Arm3, Arm4, Arm5, Arm6, Arm7, Arm8 |
Primary outcome
Number of Participants with Treatment-Related Adverse Events
Time frame: for SAD, day 1-7; for MAD, day 1-26, for FE, day1-14
Main pharmacokinetic parameters
Time frame: for SAD, day 1-7; for MAD, day 1-26,
Vd/F
Main pharmacokinetic parameters
Time frame: for SAD, day 1-7; for MAD, day 1-26,
CL/F
Main pharmacokinetic parameters
Time frame: for SAD, day 1-7; for MAD, day 1-26,
t1/2
Main pharmacokinetic parameters
Time frame: for SAD, day 1-7; for MAD, day 1-26,
Tmax
Main pharmacokinetic parameters
Time frame: for SAD, day 1-7; for MAD, day 1-26,
AUC0-∞
Main pharmacokinetic parameters
Time frame: for SAD, day 1-7; for MAD, day 1-26,
Cmax
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: Undecided. Not decided yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emir Redzepagic, MD principal investigator
CMAX Clinical Research Pty Ltd
Xiaolan Yong Chief Pharmacist, BS principal investigator
Chengdu Xinhua Hospital, China
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NS-136 tablet in people with Healthy Subjects, run by NeuShen Therapeutics at 2 sites in 2 countries.
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 6 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Zhang, PhD (8613918282581, chao.zhang@neushen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-Related Adverse Events (time frame: for SAD, day 1-7; for MAD, day 1-26, for FE, day1-14). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2024.