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

Clene Nanomedicine

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers - Male and Female

Treatments: Other: Placebo; Other: CNM-Au8

Study type: Interventional

Funder types: Industry

Identifiers

NCT02755870

AU8.1000-14-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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86 participants in 2 patient groups, including a placebo group

CNM-Au8

Experimental group

Description:

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

Treatment:

Other: CNM-Au8

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo