This is a Phase 1combined single ascending dose (SAD)/multiple ascending dose (MAD) randomized, double-blind, placebo-controlled trial to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of single and multiple ascending subcutaneous doses of LCA-0061in participants with atopic conditions (SAD) and participants with peanut allergy (MAD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
CAN001
Mississauga, Ontario, Canada
RECRUITINGOccurrence of treatment-emergent adverse events (TEAEs)
Percentage of participants by cohort and treatment arm with a TEAE. A TEAE is defined as a new condition or worsening of a preexisting condition that appeared after start of treatment.
Time frame: Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
Occurrence of TEAEs leading to discontinuation
Percentage of participants by cohort and treatment arm discontinuing treatment and/or study
Time frame: Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
Occurrence of TEAE by severity
Percentage of participants with Common Terminology Criteria for Adverse Events (CTCAE) Grade 2, 3, 4 or 5 TEAE by cohort and treatment arm
Time frame: Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
Occurrence of Clinically significant laboratory values, electrocardiograms (ECGs), and vital signs
Percentage of participants, by cohort and treatment arm, with clinically significant abnormal laboratory values, ECGs, and vital signs
Time frame: Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
Single-dose pharmacokinetic parameter- Cmax
Maximum observed serum concentration (ng/mL)
Time frame: Part A (SAD) Cohorts: Pre-dose through Day 36
Single-dose pharmacokinetic parameter- Tmax
Time at Cmax (hours)
Time frame: Part A (SAD) Cohorts: Pre-dose through Day 36
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Single-dose pharmacokinetic parameter-AUC0-∞
Area under the concentration-time curve from time 0 to infinity (hours\*ng/mL)
Time frame: Part A (SAD) Cohorts: Pre-dose through Day 36
Single-dose pharmacokinetic parameter- t½
Terminal half-life (hours)
Time frame: Part A (SAD) Cohorts: Pre-dose through Day 36
Multiple-dose pharmacokinetic parameter--Cmax
Maximum observed serum concentration (ng/mL)
Time frame: Part B (MAD) Cohorts: Pre-dose through Day 93
Multiple-dose pharmacokinetic parameter-Tmax
Time at Cmax (hours)
Time frame: Part B (MAD) Cohorts: Pre-dose through Day 93
Multiple-dose pharmacokinetic parameter-AUC0-∞
Area under the concentration-time curve from time 0 to infinity (hours\*ng/mL)
Time frame: Part B (MAD) Cohorts: Pre-dose through Day 93
Multiple-dose pharmacokinetic parameter-t½
Terminal half-life (hours)
Time frame: Part B (MAD) Cohorts: Pre-dose through Day 93
Accumulation Ratio
Accumulation ratio after last dose
Time frame: Part B (MAD) Cohorts: Pre-dose through Day 93