CAN001
Mississauga, Ontario, L4W 1N2, Canada
Location status: Recruiting
NCT Number: NCT07701954
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).
Interested in participating?
Request Info18 year–55 year
All sexes
Interventional
Phase 1
Mississauga, Ontario, L4W 1N2, Canada
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria: Part A (SAD) and Part B (MAD)
Part A Only
1.Must be otherwise healthy with history of atopy defined as one or more of the following: history of positive skin tests to common allergens, allergic conjunctivitis, food allergy, atopic dermatitis, urticaria
Part B Only
Key Exclusion Criteria: Part A and B
LCA-0061 is an antibody-based therapeutic designed to selectively bind and rapidly clear immunoglobulin E (IgE) via targeted degradation
Placebo
Time frame: Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
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
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
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
Percentage of participants, by cohort and treatment arm, with clinically significant abnormal laboratory values, ECGs, and vital signs
Time frame: Part A (SAD) Cohorts: Pre-dose through Day 36
Maximum observed serum concentration (ng/mL)
Time frame: Part A (SAD) Cohorts: Pre-dose through Day 36
Time at Cmax (hours)
Time frame: Part A (SAD) Cohorts: Pre-dose through Day 36
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
Terminal half-life (hours)
Time frame: Part B (MAD) Cohorts: Pre-dose through Day 93
Maximum observed serum concentration (ng/mL)
Time frame: Part B (MAD) Cohorts: Pre-dose through Day 93
Time at Cmax (hours)
Time frame: Part B (MAD) Cohorts: Pre-dose through Day 93
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
Terminal half-life (hours)
Time frame: Part B (MAD) Cohorts: Pre-dose through Day 93
Accumulation ratio after last dose
Contact information is provided by the study sponsor or research team.
Lycia Therapeutics, Inc.
Industry
A Randomized, Double-Blind, Placebo-Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single Doses of LCA-0061 in Atopic Healthy Participants and Multiple Doses of LCA-0061 in Participants With Peanut Allergy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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