Healthy Volunteers - Male and Female
Conditions
Brief summary
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
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.
Interventions
OTHERCNM-Au8
Clene's technology integrates nanotechnology, materials science, plasma conditioning (corona discharge), and hydro-electrocrystallization to create a new nanocatalytic drug class
OTHERPlacebo
Placebo oral suspension which matches the volume of the experimental nanocrystal suspension
Sponsors
Clene Nanomedicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment emergent adverse and serious adverse events | 49 days | Occurrence of adverse events |
| Tmax | Single dose and up to 21 days of consecutive daily dosing | Time to Cmax |
| CL/F | Single dose and up to 21 days of consecutive daily dosing | The apparent systemic clearance |
| t 1/2 | Single dose and up to 21 days of consecutive daily dosing | Terminal phase half-life |
| Cmax | Singe dose and up to 21 days of consecutive daily dosing | Maximum observed plasma concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in cytokine levels | Following a single oral dose or multiple oral doses (once daily for 21 consecutive days) | Immune modulating effects of orally administered CNM-Au8 |
Countries
Netherlands
Outcome results
None listed