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
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.
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.
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