Trial | NCT02755870  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    CNM-Au8 ...

  • Study Participants

    86
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.
Study Started
Apr 30
2015
Primary Completion
Oct 31
2016
Study Completion
Oct 31
2016
Last Update
Jun 03
2019

Other CNM-Au8

Clene's technology integrates nanotechnology, materials science, plasma conditioning (corona discharge), and hydro-electrocrystallization to create a new nanocatalytic drug class

  • Other names: Nanoparticles, clean surface nanocrystals

Other Placebo

Placebo oral suspension which matches the volume of the experimental nanocrystal suspension

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

Criteria 

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
No Results Posted