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

Healthy Volunteers - Male and Female Clinical Trial

Official title:

A Phase 1 Single-Ascending Dose (SAD) and Multiple- Ascending Dose (MAD) Study of CNM-Au8 in Healthy Male and Female Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02755870
• Other study ID #: AU8.1000-14-01
• Status: Completed
• Phase: Phase 1
• Start date: April 2015
• Est. completion date: October 2016

Study information

• Verified date: May 2019
• Source: Clene Nanomedicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers - Male and Female

Intervention

Other:
• CNM-Au8
Clene's technology integrates nanotechnology, materials science, plasma conditioning (corona discharge), and hydro-electrocrystallization to create a new nanocatalytic drug class
• Placebo
Placebo oral suspension which matches the volume of the experimental nanocrystal suspension

Locations

Country	Name	City	State
Netherlands	Centre for Human Drug Research (CHDR)	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Clene Nanomedicine

Country where clinical trial is conducted

Netherlands, 

Outcome

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