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Completed

NCT Number: NCT02755870

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

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.

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Key information

Conditions

Healthy Volunteers - Male and Female

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre for Human Drug Research (CHDR)

Leiden, 2333 CL, Netherlands

About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CNM-Au8

Other

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

Placebo

Other

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

Primary outcomes

  1. Treatment emergent adverse and serious adverse events

    Time frame: 49 days

    Occurrence of adverse events

  2. Tmax

    Time frame: Single dose and up to 21 days of consecutive daily dosing

    Time to Cmax

  3. CL/F

    Time frame: Single dose and up to 21 days of consecutive daily dosing

    The apparent systemic clearance

  4. t 1/2

    Time frame: Single dose and up to 21 days of consecutive daily dosing

    Terminal phase half-life

  5. Cmax

    Time frame: Singe dose and up to 21 days of consecutive daily dosing

    Maximum observed plasma concentration

Secondary outcomes

  1. Changes in cytokine levels

    Time frame: Following a single oral dose or multiple oral doses (once daily for 21 consecutive days)

    Immune modulating effects of orally administered CNM-Au8

Sponsors and collaborators

Lead sponsor

Clene Nanomedicine

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 29, 2016
Registry last updated
Jun 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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