A Phase I SAD and MAD Clinical Trial of CNM-Au8 in Healthy Male and Female Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase 1 Single-Ascending Dose (SAD) and Multiple- Ascending Dose (MAD) Study of CNM-Au8 in Healthy Male and Female Volunteers

Conditions
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Healthy Volunteers - Male and Female

Intervention / Treatment
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* Other: CNM-Au8
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities. Females will be non-pregnant, non-lactating, or post-menopausal All laboratory values at screening fall within normal range or are evaluated as not clinically significant Has not consumed and agrees to abstain from taking any dietary supplements or non-prescription drugs Has not consumed and agrees to abstain from taking any prescription drugs Has not consumed alcohol-containing beverages Has not consumed grapefruit or grapefruit juice Has not used tobacco- and nicotine-containing products Has the ability to understand the requirements of the study and is willing to comply with all study procedures. Exclusion Criteria: Has a history of illicit drug abuse Has clinically significant medical or psychiatric history Has donated plasma or excessive blood loss Prior participation in another clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CNM-Au8<br>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 | Other: CNM-Au8<br>* Clene's technology integrates nanotechnology, materials science, plasma conditioning (corona discharge), and hydro-electrocrystallization to create a new nanocatalytic drug class<br>* Other names: Nanoparticles, clean surface nanocrystals;|
| Placebo Comparator: Placebo<br>Placebo oral suspension which matches the volume of the experimental nanocrystal suspension | Other: Placebo<br>* Placebo oral suspension which matches the volume of the experimental nanocrystal suspension<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |