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This is a Phase 1, First-Time-In-Humans, randomized, placebo-controlled, double-blind, escalating single- and multiple-dose study to evaluate the safety, tolerability, and pharmacokinetics of CNM-Au8 in healthy male and female volunteers. There will be 2 phases to this study: a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase. The SAD Phase will be conducted first followed by the MAD phase of the study.
SAD Phase:
A total of 8 subjects will be randomly assigned in a 3:1 ratio to receive a single dose of either CNM-Au8 (n=6) or placebo (n=2) at an initial dose level of 15 mg CNM-Au8. Additional cohorts of 8 subjects will be enrolled to investigate escalating single doses of CNM-Au8 at 30, 60, and 90 mg. Cohorts will be balanced by sex with no more than 2/3rd of subjects being of one sex.
MAD Phase:
A total of 12 subjects will be randomly assigned in a 3:1 ratio to receive a multiple dose of either CNM-Au8 (n=9) or placebo (n=3) once daily for 21 days at an initial dose level of 15 mg CNM-Au8. Additional cohorts of 12 subjects will be enrolled to investigate escalating multiple doses of CNM-Au8 at 30, 60, and 90 mg CNM Au8 administered once daily for 21 days. Cohorts will be balanced by sex with no more than 2/3rd of subjects being of one sex.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CNM-Au8 | Experimental | CNM-Au8 is an orally administered, clean-surface gold nanocrystal suspension drug. It is atomically clean-surface elemental nanocrystals, free of any residual surface chemicals or surface-capping agents. CNM-Au8 15, 30, 60, 90mg as an oral suspension |
|
| Placebo | Placebo Comparator | Placebo oral suspension which matches the volume of the experimental nanocrystal suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNM-Au8 | Other | Clene's technology integrates nanotechnology, materials science, plasma conditioning (corona discharge), and hydro-electrocrystallization to create a new nanocatalytic drug class |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment emergent adverse and serious adverse events | Occurrence of adverse events | 49 days |
| Tmax | Time to Cmax | Single dose and up to 21 days of consecutive daily dosing |
| CL/F | The apparent systemic clearance | Single dose and up to 21 days of consecutive daily dosing |
| t 1/2 | Terminal phase half-life | Single dose and up to 21 days of consecutive daily dosing |
| Cmax | Maximum observed plasma concentration | Singe dose and up to 21 days of consecutive daily dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in cytokine levels | Immune modulating effects of orally administered CNM-Au8 | Following a single oral dose or multiple oral doses (once daily for 21 consecutive days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| G.J. Groeneveld, MD, PhD | Centre for Human Drug Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Human Drug Research (CHDR) | Leiden | 2333 CL | Netherlands |
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| ID | Term |
|---|---|
| D053758 | Nanoparticles |
| ID | Term |
|---|---|
| D049329 | Nanostructures |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| Placebo | Other | Placebo oral suspension which matches the volume of the experimental nanocrystal suspension |
|