Atopic Disease, Peanut Allergies
Conditions
Brief summary
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).
Interventions
DRUGLCA-0061
LCA-0061 is an antibody-based therapeutic designed to selectively bind and rapidly clear immunoglobulin E (IgE) via targeted degradation
DRUGPlacebo
Placebo
Sponsors
Lycia Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
In addition to participant and investigator, the sponsor and contract research organization (CRO) responsible for study oversight will be blinded.
Intervention model description
The study will enroll cohorts of participants who will be assigned to a dose group either in Part A or Part B
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: Part A (SAD) and Part B (MAD) 1. Must provide written consent for participation 2. Have a body mass index (BMI) within the range of 18.0 to 30.0 kg/m2 (inclusive) and body weight ≥ 50kg at screening 3. Have elevated serum IgE at screening 4. 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. 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 1. Be otherwise healthy with history of peanut allergy 2. Elevated peanut-specific serum IgE within 6 months of screening 3. Have positive skin prick test (SPT) to peanuts at screening Key
Exclusion criteria
Part A and B 1. Pregnant or lactating 2. History of clinically relevant underlying comorbidities including: 1. chronic obstructive pulmonary disease 2. myocardial infarction 3. chronic heart failure or unstable angina pectoris 4. hyperlipidemia 5. liver disease or known hepatic or biliary abnormalities \[except Gilbert's disease or asymptomatic gallstones\] 6. autoimmune or connective tissue disease 7. chronic inflammatory disease 8. persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals 9. poorly controlled atopic dermatitis requiring treatment with phototherapy, systemic immunosuppressants, or immunomodulators 10. Poorly controlled asthma 11. poorly controlled hypertension 3. clinically significant abnormal electrocardiogram or laboratory tests (hematology, clinical chemistries, liver function tests, lipid panel, serology, or urinalysis) at screening 4. Currently receiving immunotherapy for food allergies 5. Use of nicotine containing products (excluding nicotine patches or gum for smoking cessation) within 6 months prior to screening. 6. Positive test for alcohol or illicit drugs at screening or prior to dosing. 7. Other conditions or concomitant medications that are excluded by the protocol, or in the opinion of the investigator, or sponsor representative, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of treatment-emergent adverse events (TEAEs) | 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. |
| Occurrence of TEAEs leading to discontinuation | 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 |
| Occurrence of TEAE by severity | 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 |
| Occurrence of Clinically significant laboratory values, electrocardiograms (ECGs), and vital signs | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Single-dose pharmacokinetic parameter- Cmax | Part A (SAD) Cohorts: Pre-dose through Day 36 | Maximum observed serum concentration (ng/mL) |
| Single-dose pharmacokinetic parameter- Tmax | Part A (SAD) Cohorts: Pre-dose through Day 36 | Time at Cmax (hours) |
| Single-dose pharmacokinetic parameter-AUC0-∞ | Part A (SAD) Cohorts: Pre-dose through Day 36 | Area under the concentration-time curve from time 0 to infinity (hours\*ng/mL) |
| Single-dose pharmacokinetic parameter- t½ | Part A (SAD) Cohorts: Pre-dose through Day 36 | Terminal half-life (hours) |
| Multiple-dose pharmacokinetic parameter--Cmax | Part B (MAD) Cohorts: Pre-dose through Day 93 | Maximum observed serum concentration (ng/mL) |
| Multiple-dose pharmacokinetic parameter-Tmax | Part B (MAD) Cohorts: Pre-dose through Day 93 | Time at Cmax (hours) |
| Multiple-dose pharmacokinetic parameter-AUC0-∞ | Part B (MAD) Cohorts: Pre-dose through Day 93 | Area under the concentration-time curve from time 0 to infinity (hours\*ng/mL) |
| Multiple-dose pharmacokinetic parameter-t½ | Part B (MAD) Cohorts: Pre-dose through Day 93 | Terminal half-life (hours) |
| Accumulation Ratio | Part B (MAD) Cohorts: Pre-dose through Day 93 | Accumulation ratio after last dose |
Countries
Canada
Contacts
CONTACTHead of Clinical Operations
STUDY_DIRECTORNadia Tchao, MD
Lycia Therapeutics, Inc.
Outcome results
None listed