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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers - Male and Female
• Intervention / Treatment: Other: CNM-Au8; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Leiden, Netherlands, 2333 CL
    • Centre for Human Drug Research (CHDR)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment emergent adverse and serious adverse events	Occurrence of adverse events	49 days
Tmax	Time to Cmax	Single dose and up to 21 days of consecutive daily dosing
CL/F	The apparent systemic clearance	Single dose and up to 21 days of consecutive daily dosing
t 1/2	Terminal phase half-life	Single dose and up to 21 days of consecutive daily dosing
Cmax	Maximum observed plasma concentration	Singe dose and up to 21 days of consecutive daily dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cytokine levels	Immune modulating effects of orally administered CNM-Au8	Following a single oral dose or multiple oral doses (once daily for 21 consecutive days)

Collaborators and Investigators

• Sponsor: Clene Nanomedicine
• Investigators: Principal Investigator: G.J. Groeneveld, MD, PhD, Centre for Human Drug Research

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: April 23, 2016
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (Estimate): April 29, 2016

Study Record Updates

• Last Update Posted (Actual): June 3, 2019
• Last Update Submitted That Met QC Criteria: May 30, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: AU8.1000-14-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided