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The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of NSHO-101 in Healthy Participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NSHO-101 Dose A | Experimental | Oral dose A of NSHO-101 QD for 14 days |
|
| NSHO-101 Dose B | Experimental | Oral dose B of NSHO-101 QD for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NSHO-101 | Drug | Dose form - tablet Route of administration - oral Regimen / Treatment period - QD for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) | Day 1 to Day 18 | |
| Pharmacokinetics: Area Under the Concentration Curve (AUC) | Day 1 to Day 18 | |
| Pharmacokinetics: Trough Concentration (Ctrough) | Day 1 to Day 18 | |
| Pharmacokinetics: Half-life | Day 1 to Day 18 | |
| Pharmacokinetics: Time to Maximum Concentration (tmax) | Day 1 to Day 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Emergent Adverse Events | Incidence of TEAEs | Day 1 to 14 |
| Serious Treatment Emergent Adverse Events | Incidence of STEAEs | Day 1 to Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bittoo Kanwar, MD, MD | Contact | 973-314-8995 | operations@enshorx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cenexel Anaheim CA | Recruiting | Anaheim | California | 92801 | United States |
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To evaluate pharmacokinetics and safety of NSHO-101
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