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

Phase 1

Completed

• Conditions: Healthy Volunteers - Male and Female
• Interventions: Other: Placebo; Other: CNM-Au8

• Registration Number: NCT02755870
• Lead Sponsor: Clene Nanomedicine

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2016-04-23
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-04-29
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-30
• Last Update Posted: 2019-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo oral suspension which matches the volume of the experimental nanocrystal suspension
CNM-Au8	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre for Human Drug Research (CHDR); 🇳🇱 Leiden, Netherlands