Healthy Volunteers - Male and FemalePhase 1NCT02755870
A Phase I SAD and MAD Clinical Trial of CNM-Au8 in Healthy Male and Female Volunteers
A Phase 1 study testing CNM-Au8 in people with Healthy Volunteers - Male and Female, run by Clene Nanomedicine at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers - Male and Female
- What is being tested?
- CNM-Au8
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2015to Oct 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Single-Ascending Dose (SAD) and Multiple- Ascending Dose (MAD) Study 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.
Read the 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.
- Conditions
- Healthy Volunteers - Male and Female
- Being tested
- CNM-Au8, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNM-Au8Other
Also called Nanoparticles, clean surface nanocrystals
Clene's technology integrates nanotechnology, materials science, plasma conditioning (corona discharge), and hydro-electrocrystallization to create a new nanocatalytic drug class
PlaceboOther
Placebo oral suspension which matches the volume of the experimental nanocrystal suspension
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: CNM-Au8 |
| Placebo | Placebo comparator | Placebo oral suspension which matches the volume of the experimental nanocrystal suspension Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent adverse and serious adverse events
Occurrence of adverse events
Measured: 49 days
Tmax
Time to Cmax
Measured: Single dose and up to 21 days of consecutive daily dosing
CL/F
The apparent systemic clearance
Measured: Single dose and up to 21 days of consecutive daily dosing
t 1/2
Terminal phase half-life
Measured: Single dose and up to 21 days of consecutive daily dosing
Cmax
Maximum observed plasma concentration
Measured: Singe dose and up to 21 days of consecutive daily dosing
Secondary outcomes (1)
Changes in cytokine levels
Immune modulating effects of orally administered CNM-Au8
Measured: Following a single oral dose or multiple oral doses (once daily for 21 consecutive days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startApr 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers - Male and FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clene Nanomedicine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- G.J. Groeneveld, MD, PhD, Principal investigator, Centre for Human Drug Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755870
- Sponsor's protocol ID
- AU8.1000-14-01
- Status last verified
- May 2019
- First submitted
- 23 Apr 2016
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Single-Ascending Dose (SAD) and Multiple- Ascending Dose (MAD) Study of CNM-Au8 in Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT02755870
- Acronym / sponsor ID
- AU8.1000-14-01
- Conditions
- Healthy Volunteers - Male and Female
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Clene NanomedicineIndustry (pharma, biotech, devices)
- Study start
- Apr 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CNM-Au8 | Experimental | Other: CNM-Au8CNM-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 | Other: PlaceboPlacebo oral suspension which matches the volume of the experimental nanocrystal suspension |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CNM-Au8Also: Nanoparticles, clean surface nanocrystalsClene's technology integrates nanotechnology, materials science, plasma conditioning (corona discharge), and hydro-electrocrystallization to create a new nanocatalytic drug class | Other | CNM-Au8 |
| PlaceboPlacebo oral suspension which matches the volume of the experimental nanocrystal suspension | Other | Placebo |
Primary outcome
Treatment emergent adverse and serious adverse events
Time frame: 49 days
Occurrence of adverse events
Tmax
Time frame: Single dose and up to 21 days of consecutive daily dosing
Time to Cmax
CL/F
Time frame: Single dose and up to 21 days of consecutive daily dosing
The apparent systemic clearance
t 1/2
Time frame: Single dose and up to 21 days of consecutive daily dosing
Terminal phase half-life
Cmax
Time frame: Singe dose and up to 21 days of consecutive daily dosing
Maximum observed plasma concentration
1 secondary outcome
Changes in cytokine levels
Time frame: Following a single oral dose or multiple oral doses (once daily for 21 consecutive days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
G.J. Groeneveld, MD, PhD principal investigator
Centre for Human Drug Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CNM-Au8 in people with Healthy Volunteers - Male and Female, run by Clene Nanomedicine at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment emergent adverse and serious adverse events (time frame: 49 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.