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

Sponsor
Clene Nanomedicine (Industry)
Overall Status
Completed
CT.gov ID
NCT02755870
Collaborator
(none)
86
Enrollment
1
Location
2
Arms
18
Actual Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: CNM-Au8
  • Other: Placebo
 Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Single-Ascending Dose (SAD) and Multiple- Ascending Dose (MAD) Study of CNM-Au8 in Healthy Male and Female Volunteers
Actual Study Start Date :
Apr 1, 2015
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: CNM-Au8

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
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 Comparator: Placebo

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

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

    Outcome Measures

    Primary Outcome Measures

    1. Treatment emergent adverse and serious adverse events [49 days]

      Occurrence of adverse events

    2. Tmax [Single dose and up to 21 days of consecutive daily dosing]

      Time to Cmax

    3. CL/F [Single dose and up to 21 days of consecutive daily dosing]

      The apparent systemic clearance

    4. t 1/2 [Single dose and up to 21 days of consecutive daily dosing]

      Terminal phase half-life

    5. Cmax [Singe dose and up to 21 days of consecutive daily dosing]

      Maximum observed plasma concentration

    Secondary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre for Human Drug Research (CHDR) Leiden Netherlands 2333 CL

    Sponsors and Collaborators

    • Clene Nanomedicine

    Investigators

    • Principal Investigator: G.J. Groeneveld, MD, PhD, Centre for Human Drug Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Clene Nanomedicine
    ClinicalTrials.gov Identifier:
    NCT02755870
    Other Study ID Numbers:
    • AU8.1000-14-01
    First Posted:
    Apr 29, 2016
    Last Update Posted:
    Jun 3, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided

    Study Results

    No Results Posted as of Jun 3, 2019