A Phase I SAD and MAD Clinical Trial of CNM-Au8 in Healthy Male and Female Volunteers
NCT ID: NCT02755870
Last Updated: 2019-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
86 participants
INTERVENTIONAL
2015-04-30
2016-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
CNM-Au8
Clene's technology integrates nanotechnology, materials science, plasma conditioning (corona discharge), and hydro-electrocrystallization to create a new nanocatalytic drug class
Placebo
Placebo oral suspension which matches the volume of the experimental nanocrystal suspension
Placebo
Placebo oral suspension which matches the volume of the experimental nanocrystal suspension
Interventions
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CNM-Au8
Clene's technology integrates nanotechnology, materials science, plasma conditioning (corona discharge), and hydro-electrocrystallization to create a new nanocatalytic drug class
Placebo
Placebo oral suspension which matches the volume of the experimental nanocrystal suspension
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 clinically significant medical or psychiatric history
* Has donated plasma or excessive blood loss
* Prior participation in another clinical trial
18 Years
45 Years
ALL
Yes
Sponsors
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Clene Nanomedicine
INDUSTRY
Responsible Party
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Principal Investigators
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G.J. Groeneveld, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre for Human Drug Research
Locations
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Centre for Human Drug Research (CHDR)
Leiden, , Netherlands
Countries
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Other Identifiers
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AU8.1000-14-01
Identifier Type: -
Identifier Source: org_study_id
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