This is a Phase 1, double-blind, randomized, placebo-controlled, single-dose and multiple-dose study of CRN01941 in up to 119 healthy male and female subjects. This single-center study will be conducted in 3 parts: a single-ascending dose phase (up to 8 cohorts, 8 subjects/cohort), a multiple-ascending dose phase (up to 5 cohorts, 9 subjects/cohort), and single dose phase in elderly subjects (1 cohort, 10 subjects).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
57
Investigational drug
Investigational drug
Placebo
Linear Clinical Research
Perth, Western Australia, Australia
Number of participants with treatment emergent adverse events by severity
Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Number of participants with serious adverse events (SAEs)
Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Number of participants with clinically significant changes in vital signs
Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Number of participants with ECG abnormalities
Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Number of participants with clinical laboratory abnormalities
Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Pharmacokinetics (AUC)
Assessment of the plasma area under the curve of CRN01941
Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Pharmacokinetics (Cmax)
Assessment of the maximum observed plasma concentration of CRN01941
Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Pharmacokinetics (Tmax)
Assessment of the time to reach Cmax for CRN01941
Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Pharmacokinetics (T1/2)
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Placebo
Assessment of the elimination half-life of CRN01941
Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8