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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20244269 | Other Identifier | China NMPA |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm1 | Experimental | NS-136 SAD Dose 1 |
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| Arm2 | Experimental | NS-136 SAD Dose 2 |
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| Arm3 | Experimental | NS-136 SAD Dose 3 |
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| Arm4 | Experimental | NS-136 SAD Dose 4 |
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| Arm5 | Experimental | Arm5 NS-136 MAD Dose 1 |
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| Arm6 | Experimental | Arm5 NS-136 MAD Dose 2 |
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| Arm7 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | NS-136 matching placebo |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Related Adverse Events | for SAD, day 1-7; for MAD, day 1-26, for FE, day1-14 | |
| Main pharmacokinetic parameters | Vd/F | for SAD, day 1-7; for MAD, day 1-26, |
| Main pharmacokinetic parameters | CL/F | for SAD, day 1-7; for MAD, day 1-26, |
| Main pharmacokinetic parameters | t1/2 | for SAD, day 1-7; for MAD, day 1-26, |
| Main pharmacokinetic parameters | Tmax | for SAD, day 1-7; for MAD, day 1-26, |
| Main pharmacokinetic parameters | AUC0-∞ | for SAD, day 1-7; for MAD, day 1-26, |
| Main pharmacokinetic parameters | Cmax | for SAD, day 1-7; for MAD, day 1-26, |
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Inclusion Criteria
Study subjects must meet all of the following criteria for study entry:
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from study entry:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao Zhang, PhD | Contact | 8613918282581 | chao.zhang@neushen.com | |
| Yangyi Qu, MS | Contact | 8613262952232 | yangyi.qu@neushen.com |
| Name | Affiliation | Role |
|---|---|---|
| Emir Redzepagic, MD | CMAX Clinical Research Pty Ltd | Principal Investigator |
| Xiaolan Yong Chief Pharmacist, BS | Chengdu Xinhua Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX Clinical Research Pty Ltd | Recruiting | Adelaide | South Australia | 5000 | Australia |
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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)
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FE Grp A |
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| Arm8 | Experimental | FE Grp B |
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| Arm9 | Placebo Comparator | NS-136 SAD Dose 1 PBO |
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| Arm10 | Placebo Comparator | NS-136 SAD Dose 2 PBO |
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| Arm11 | Placebo Comparator | NS-136 SAD Dose 3 PBO |
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| Arm12 | Placebo Comparator | NS-136 SAD Dose 4 PBO |
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| Arm13 | Placebo Comparator | NS-136 MAD Dose 1 PBO |
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| Arm14 | Placebo Comparator | NS-136 MAD Dose 2 PBO |
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| NS-136 tablet | Drug | Investigational product NS-136 |
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| Chengdu Xinhua Hospital | Recruiting | Chengdu | Sichuan | 610000 | China |
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