A two (2) part study to evaluate the safety, tolerability and PK of ADX-914
Part 1 - SAD: It is expected that there will be up to 6 cohorts of 8 participants per cohort. In each cohort, participants will be randomly assigned in a 3:1 ratio to receive either ADX-914 or matching placebo. It is planned that for each cohort in Part 1 a staggered 'sentinel' dose design will be used. Part 2 - MAD It is expected that there will be up to 3 cohorts of 8 participants per cohort. In each cohort, participants will be randomly assigned in a 3:1 ratio to receive either ADX-914 or matching placebo. Doses will occur every 2 weeks, for a total of 4 doses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
42
Nucleus Network
Melbourne, Victoria, Australia
Number of subjects with adverse events
Listing and summary of AE incidence
Time frame: Screening to end of study, up to 18 weeks
Number of subjects with Physical exam findings
Listing of clinically significant changes in PE findings
Time frame: Screening to end of study, up to 18 weeks
Number of subjects with Clinical safety lab changes
Listing and change from baseline to end of study
Time frame: Screening to end of study, up to 18 weeks
Number of subjects with Systolic blood pressure changes
Listing and change from baseline to end of study
Time frame: Screening to end of study, up to 18 weeks
Number of subjects with Heart rate changes
Listing and change from baseline to end of study
Time frame: Screening to end of study, up to 18 weeks
Number of subjects with 12 Lead ECG changes
Change in 12-lead ECG parameters from baseline to end of study
Time frame: Screening to end of study, up to 18 weeks
Maximum observed plasma concentration, Cmax
Of ADX-914
Time frame: Predose to Day 91 (SAD) and Day 127 (MAD)
Time to reach maximum observed plasma concentration, Tmax
Of ADX-914
Time frame: Predose to Day 91 (SAD) and Day 127 (MAD)
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Matching multiple dose placebo
Area Under the plasma concentration time curve, AUC
Of ADX-914
Time frame: Predose to Day 91 (SAD) and Day 127 (MAD)