A Phase I trial to evaluate the safety, tolerability and Pharmacokinetics of ALS-4 (IM032) in a single ascending dose (SAD) and multiple ascending dose (MAD) in healthy adult subjects.
This is a randomized, double-blind, placebo-controlled, first-in-human (FIH) study of ALS-4 (IM032) in healthy male and non-pregnant, non-lactating female volunteers. The study will consist of two phases: SAD and MAD. The study will evaluate the safety, tolerability and pharmacokinetic (PK) in 6 planned SAD cohorts (5 dose levels, and 1 cohort to evaluate for a potential food or circadian effect) with sentinel design (n=8 per cohort, total randomized 6 active: 2 placebo; sentinel design not applicable when a cohort with the same or a higher drug exposure has already been evaluated) and 3 planned MAD cohorts with sentinel design (n=8 per cohort, total randomized 6 active: 2 placebo).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
72
BioPharma Services Inc.
North York, Ontario, Canada
Number of participants with Adverse Events
An adverse event is any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the Study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product.
Time frame: Up to 28 days
Area under the plasma concentration-time curve from time-zero extrapolated to infinite time (AUCinf)
Time frame: Up to 24 hours post dose
Area under the plasma concentration vs time curve from time 0 to the time of the last measurable concentration, or last sampling time t (AUCt)
Time frame: Up to 24 hours post dose
Time of maximum observed plasma concentration (Cmax)
Time frame: Up to 24 hours post dose
Time of maximum plasma concentration (Tmax)
Time frame: Up to 24 hours post dose
Terminal elimination rate constant (λz)
Time frame: Up to 24 hours post dose
Terminal elimination half-life(T1/2)
Time frame: Up to 24 hours post dose
Plasma concentration at the end of the dosing interval at steady state on Day 14 (Ctau)
Time frame: Up to 24 hours post dose
Minimum steady-state plasma concentration during a dosage interval on Day 14 (Cmin)
Time frame: Up to 24 hours post dose
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Multiple dose of ALS-4 up to two times daily
Multiple dose of placebo up to two times daily
Maximum plasma concentration during a dosage interval (x = 1 or 14) (Cmax, Day x)
Time frame: Up to 24 hours post dose
Area under the plasma concentration-time curve during a dosage interval on Day x (x = 1 or 14) (AUC12, Day x)
Time frame: Up to 24 hours post dose
Accumulation ratio from Cmax from Day 1 to Day 14 (AR(Cmax))
Time frame: Up to 24 hours post dose
Accumulation ratio from AUC from Day 1 to Day 14 (AR(AUC))
Time frame: Up to 24 hours post dose
Time until maximum plasma concentration reached on Day x (x = 1 or 14) (Tmax,Day x)
Time frame: Up to 24 hours post dose