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

Clene Nanomedicine86 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteers - Male and Female

Interventions

CNM-Au8OTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Centre for Human Drug Research (CHDR)

Leiden, Netherlands

Outcomes

Primary Outcomes

Treatment emergent adverse and serious adverse events

Occurrence of adverse events

Time frame: 49 days

Tmax

Time to Cmax

Time frame: Single dose and up to 21 days of consecutive daily dosing

CL/F

The apparent systemic clearance

Time frame: Single dose and up to 21 days of consecutive daily dosing

t 1/2

Terminal phase half-life

Time frame: Single dose and up to 21 days of consecutive daily dosing

Cmax

Maximum observed plasma concentration

Time frame: Singe dose and up to 21 days of consecutive daily dosing

Secondary Outcomes

Changes in cytokine levels

Immune modulating effects of orally administered CNM-Au8

Time frame: Following a single oral dose or multiple oral doses (once daily for 21 consecutive days)

Data from ClinicalTrials.gov

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