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
Qualifiers
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
Treatments tested in this trial
- LCA-0061
- Placebo
Treatment groups
72 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov