A Phase 1 interventional study of CNM-Au8 and Placebo in Healthy Volunteers - Male and Female, sponsored by Clene Nanomedicine. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-03.
Sponsored by Clene Nanomedicine · Phase 1, Interventional, and Treatment
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.
Clene Nanomedicine is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Placebo oral suspension which matches the volume of the experimental nanocrystal suspension
Other: Placebo
Clene's technology integrates nanotechnology, materials science, plasma conditioning (corona discharge), and hydro-electrocrystallization to create a new nanocatalytic drug class
Also known as: Nanoparticles, clean surface nanocrystals
Placebo oral suspension which matches the volume of the experimental nanocrystal suspension
Treatment emergent adverse and serious adverse events
Occurrence of adverse events
Time frame: 49 days
Tmax
Time to Cmax
Time frame: Single dose and up to 21 days of consecutive daily dosing
CL/F
The apparent systemic clearance
Time frame: Single dose and up to 21 days of consecutive daily dosing
t 1/2
Terminal phase half-life
Time frame: Single dose and up to 21 days of consecutive daily dosing
Cmax
Maximum observed plasma concentration
Time frame: Singe dose and up to 21 days of consecutive daily dosing
Changes in cytokine levels
Immune modulating effects of orally administered CNM-Au8
Time frame: Following a single oral dose or multiple oral doses (once daily for 21 consecutive days)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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