Atopic DiseasePhase 1NCT07701954
Single Ascending and Multiple Ascending Dose Study of LCA-0061
A Phase 1 study testing LCA-0061 in people with Atopic Disease and Peanut Allergies, run by Lycia Therapeutics, Inc. at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Atopic Disease, Peanut Allergies
- What is being tested?
- LCA-0061
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- 26 Jun 2026to Apr 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- 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
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- Part B Only
- Be otherwise healthy with history of peanut allergy
- Elevated peanut-specific serum IgE within 6 months of screening
- Have positive skin prick test (SPT) to peanuts at screening
Who cannot join
- Pregnant or lactating
- History of clinically relevant underlying comorbidities including:
- chronic obstructive pulmonary disease
- myocardial infarction
- chronic heart failure or unstable angina pectoris
- hyperlipidemia
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- liver disease or known hepatic or biliary abnormalities [except Gilbert's disease or asymptomatic gallstones]
- autoimmune or connective tissue disease
- chronic inflammatory disease
- persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals
- poorly controlled atopic dermatitis requiring treatment with phototherapy, systemic immunosuppressants, or immunomodulators
- Poorly controlled asthma
- poorly controlled hypertension
- clinically significant abnormal electrocardiogram or laboratory tests (hematology, clinical chemistries, liver function tests, lipid panel, serology, or urinalysis) at screening
- Currently receiving immunotherapy for food allergies
- Use of nicotine containing products (excluding nicotine patches or gum for smoking cessation) within 6 months prior to screening.
- Positive test for alcohol or illicit drugs at screening or prior to dosing.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
CAN001
Mississauga, Ontario, L4W 1N2
Principal Investigator, 650-392-3357, LCA-0061studyinquiry@lyciatx.com
About this study
Official title: 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
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).
- Conditions
- Atopic Disease, Peanut Allergies
- Being tested
- LCA-0061, Placebo
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCA-0061Drug
LCA-0061 is an antibody-based therapeutic designed to selectively bind and rapidly clear immunoglobulin E (IgE) via targeted degradation
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part A - LCA-0061 (SAD) | Experimental | Participants in cohorts 1-5 will receive single ascending dose levels of LCA-0061 Receives: Drug: LCA-0061 |
| Part B - LCA-0061 (MAD) | Experimental | Participants in cohorts 1-4 will receive multiple ascending dose levels of LCA-0061 Receives: Drug: LCA-0061 |
| Part A (SAD) | Placebo comparator | Participants in cohorts 1-5 will receive a single dose of Placebo Receives: Drug: Placebo |
| Part B (MAD) | Placebo comparator | Participants in cohorts 1-4 will receive multiple doses of Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
Secondary outcomes (9)
Single-dose pharmacokinetic parameter- Cmax
Maximum observed serum concentration (ng/mL)
Measured: Part A (SAD) Cohorts: Pre-dose through Day 36
Single-dose pharmacokinetic parameter- Tmax
Time at Cmax (hours)
Measured: Part A (SAD) Cohorts: Pre-dose through Day 36
Single-dose pharmacokinetic parameter-AUC0-∞
Area under the concentration-time curve from time 0 to infinity (hours*ng/mL)
Measured: Part A (SAD) Cohorts: Pre-dose through Day 36
Single-dose pharmacokinetic parameter- t½
Terminal half-life (hours)
Measured: Part A (SAD) Cohorts: Pre-dose through Day 36
Multiple-dose pharmacokinetic parameter--Cmax
Maximum observed serum concentration (ng/mL)
Measured: Part B (MAD) Cohorts: Pre-dose through Day 93
Multiple-dose pharmacokinetic parameter-Tmax
Time at Cmax (hours)
Measured: 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)
Measured: Part B (MAD) Cohorts: Pre-dose through Day 93
Multiple-dose pharmacokinetic parameter-t½
Terminal half-life (hours)
Measured: Part B (MAD) Cohorts: Pre-dose through Day 93
Accumulation Ratio
Accumulation ratio after last dose
Measured: Part B (MAD) Cohorts: Pre-dose through Day 93
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start26 Jun 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study will enroll cohorts of participants who will be assigned to a dose group either in Part A or Part B
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lycia Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nadia Tchao, MD, Study director, Lycia Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701954
- Sponsor's protocol ID
- LCA-0061-01
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Phase 1 first-in-human study