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| Name | Class |
|---|---|
| NeuHyll Therapeutics Inc | INDUSTRY |
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The goal of this study is to evaluate the safety, tolerability and pharmacokinetics of NHL907 when administered as multiple oral doses in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NHL907 Dose 1 | Experimental | NHL907 Dose 1 |
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| NHL907 Dose 2 | Experimental | NHL907 Dose 2 |
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| NHL907 Dose 3 | Experimental | NHL907 Dose 3 |
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| NHL907 Dose 4 | Experimental | NHL907 Dose 4 |
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| NHL907 Dose 5 | Experimental | NHL907 Dose 5 |
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| NHL907 Dose 6 | Experimental | NHL907 Dose 6 |
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| NHL907 Dose 7 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NHL907 | Drug | Investigational product NHL907 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment Emergent Adverse Events | Baseline to 7 days after the last dose (Day 14) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum observed plasma concentration | Day 1, Day 7 | |
| Tmax: Time of occurrence of Cmax | Day 1, Day 7 | |
| AUC0-24: Area under the concentration-time curve from 0 to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
If an individual meets any of the following criteria, they will be ineligible for this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James Connell, MD | Contact | +61 (0)8 7088 7900 | james.connell@cmax.com.au |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX Clinical Research Pty Ltd | Recruiting | Adelaide | South Australia | 5000 | Australia |
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NHL907 Dose 7 |
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| NHL907 Dose 8 | Experimental | NHL907 Dose 8 |
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| Placebo Dose 1 | Placebo Comparator | Placebo for Dose 1 |
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| Placebo Dose 2 | Placebo Comparator | Placebo for Dose 2 |
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| Placebo Dose 3 | Placebo Comparator | Placebo for Dose 3 |
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| Placebo Dose 4 | Placebo Comparator | Placebo for Dose 4 |
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| Placebo Dose 5 | Placebo Comparator | Placebo for Dose 5 |
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| Placebo Dose 6 | Placebo Comparator | Placebo for Dose 6 |
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| Placebo Dose 7 | Placebo Comparator | Placebo for Dose 7 |
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| Placebo Dose 8 | Placebo Comparator | Placebo for Dose 8 |
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| Placebo | Drug | NHL907 matching placebo |
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| Day 1, Day 7 |
| AUC0-inf: Area under the concentration-time curve from 0 to infinity | Day 1, Day 7 |
| Cmax/dose: Cmax normalized by dose | Day 1, Day 7 |
| CL/F: Apparent total clearance | Day 1, Day 7 |
| Vz/F: Apparent volume of distribution | Day 1, Day 7 |
| AUC0-24/dose: AUC0-24 normalized by dose | Day 1, Day 7 |
| AUC0-inf/dose: AUC0-inf normalized by dose | Day 1, Day 7 |
| t1/2: Apparent terminal elimination half-life | Day 1, Day 7 |
| Ctrough: Trough plasma concentration | Day 4-7 |
| RA Cmax: Observed accumulation ratio based on Cmax | Day 7 to Day 1 |