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

NCT02755870 | Completed Phase 1 DMC

• 1 other identifier: AU8.1000-14-01
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers - Male and Female

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Changes in cytokine levels

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

Study Arms (2)

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

Other: CNM-Au8

Placebo

PLACEBO COMPARATOR

Placebo oral suspension which matches the volume of the experimental nanocrystal suspension

Other: Placebo

Interventions

CNM-Au8 OTHER

Clene's technology integrates nanotechnology, materials science, plasma conditioning (corona discharge), and hydro-electrocrystallization to create a new nanocatalytic drug class

Also known as: Nanoparticles, clean surface nanocrystals

CNM-Au8

Placebo OTHER

Placebo oral suspension which matches the volume of the experimental nanocrystal suspension

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Clene Nanomedicine: lead

Study Sites (1)

Centre for Human Drug Research (CHDR)

Leiden, 2333 CL, Netherlands

Location

MeSH Terms

Interventions

Nanoparticles

Intervention Hierarchy (Ancestors)

Nanostructures; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• G.J. Groeneveld, MD, PhD

  Centre for Human Drug Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2016
• First Posted: April 29, 2016
• Study Start: April 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: June 3, 2019

Record last verified: 2019-05

Locations

NL (1)