Single Ascending and Multiple Ascending Dose Study of LCA-0061
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorLycia Therapeutics, Inc.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must provide written consent for participation
Have a body mass index (BMI) within the range of 18.0 to 30.0 kg/m2 (inclusive) and body weight ≥ 50kg at screening
Have elevated serum IgE at screening
Female participants of childbearing potential or male participants capable of fathering a child must be willing to use highly effective methods of contraception throughout the study and for at least 30 days after the last dose of the investigational product.
Disqualifiers
Pregnant or lactating
chronic obstructive pulmonary disease
myocardial infarction
chronic heart failure or unstable angina pectoris
Trial design
Design model
Sequential
Treatments tested in this trial
LCA-0061
DrugLCA-0061 is an antibody-based therapeutic designed to selectively bind and rapidly clear immunoglobulin E (IgE) via targeted degradation
Placebo
DrugPlacebo
Treatment groups
72 Participants
are divided into 4 treatment groupsGroup A: Part A - LCA-0061 (SAD)Experimental treatment 1 intervention
Group B: Part B - LCA-0061 (MAD)Experimental treatment 1 intervention
Group C: Part A (SAD)Placebo comparator 1 intervention
Group D: Part B (MAD)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Occurrence 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 932
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 933
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 934
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 93Secondary outcomes
1
Single-dose pharmacokinetic parameter- Cmax
Maximum observed serum concentration (ng/mL)
Time frame
Part A (SAD) Cohorts: Pre-dose through Day 362
Single-dose pharmacokinetic parameter- Tmax
Time at Cmax (hours)
Time frame
Part A (SAD) Cohorts: Pre-dose through Day 363
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 364
Single-dose pharmacokinetic parameter- t½
Terminal half-life (hours)
Time frame
Part A (SAD) Cohorts: Pre-dose through Day 36Sponsors and contacts
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Source ClinicalTrials.gov