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

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ClinicalTrials.gov Identifier: NCT02755870
Recruitment Status : Completed
First Posted : April 29, 2016
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Clene Nanomedicine

Study Description
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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
Healthy Volunteers - Male and Female 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
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Study Type : Interventional  (Clinical Trial)
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 : April 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016
Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02755870


Locations
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Netherlands
Centre for Human Drug Research (CHDR)
Leiden, Netherlands, 2333 CL
Sponsors and Collaborators
Clene Nanomedicine
Investigators
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Principal Investigator: G.J. Groeneveld, MD, PhD Centre for Human Drug Research
More Information
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Responsible Party: Clene Nanomedicine
ClinicalTrials.gov Identifier: NCT02755870    
Other Study ID Numbers: AU8.1000-14-01
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided