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

NCT02755870 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2019-06-03

No results posted yet for this study

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

Interventions

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

Placebo

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

Sponsors & Collaborators

  • Clene Nanomedicine

    lead INDUSTRY

Principal Investigators

  • G.J. Groeneveld, MD, PhD · Centre for Human Drug Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02755870 on ClinicalTrials.gov