Clinical trial NCT02755870: A Phase I SAD and MAD Clinical Trial of CNM-Au8 in Healthy Male and Female Volunteers
Official title: A Phase 1 Single-Ascending Dose (SAD) and Multiple- Ascending Dose (MAD) Study of CNM-Au8 in Healthy Male and Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers - Male and Female
Lead sponsor: Clene Nanomedicine
Sponsor class: INDUSTRY
First posted: 2016-04-29
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Treatment emergent adverse and serious adverse events
timeFrame: 49 days
measure: Tmax
timeFrame: Single dose and up to 21 days of consecutive daily dosing
measure: CL/F
timeFrame: Single dose and up to 21 days of consecutive daily dosing
measure: t 1/2
timeFrame: Single dose and up to 21 days of consecutive daily dosing
measure: Cmax
timeFrame: Singe dose and up to 21 days of consecutive daily dosing
Secondary outcomes:
measure: Changes in cytokine levels
timeFrame: Following a single oral dose or multiple oral doses (once daily for 21 consecutive days)
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Centre for Human Drug Research (CHDR)
Study officials:
affiliation: Centre for Human Drug Research
name: G.J. Groeneveld, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: