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Single Ascending and Multiple Ascending Dose Study of LCA-0061

13. juli 2026 oppdatert av: Lycia Therapeutics, Inc.

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).

Studieoversikt

Status

Rekruttering

Studietype

Intervensjonell

Registrering (Antatt)

72

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Part A - LCA-0061 (SAD)
Participants in cohorts 1-5 will receive single ascending dose levels of LCA-0061
LCA-0061 is an antibody-based therapeutic designed to selectively bind and rapidly clear immunoglobulin E (IgE) via targeted degradation
Eksperimentell: Part B - LCA-0061 (MAD)
Participants in cohorts 1-4 will receive multiple ascending dose levels of LCA-0061
LCA-0061 is an antibody-based therapeutic designed to selectively bind and rapidly clear immunoglobulin E (IgE) via targeted degradation
Placebo komparator: Part A (SAD)
Participants in cohorts 1-5 will receive a single dose of Placebo
Placebo
Placebo komparator: Part B (MAD)
Participants in cohorts 1-4 will receive multiple doses of Placebo
Placebo

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Occurrence of treatment-emergent adverse events (TEAEs)
Tidsramme: 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.
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
Tidsramme: 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
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
Tidsramme: 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
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
Tidsramme: 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
Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Single-dose pharmacokinetic parameter- Cmax
Tidsramme: Part A (SAD) Cohorts: Pre-dose through Day 36
Maximum observed serum concentration (ng/mL)
Part A (SAD) Cohorts: Pre-dose through Day 36
Single-dose pharmacokinetic parameter- Tmax
Tidsramme: Part A (SAD) Cohorts: Pre-dose through Day 36
Time at Cmax (hours)
Part A (SAD) Cohorts: Pre-dose through Day 36
Single-dose pharmacokinetic parameter-AUC0-∞
Tidsramme: Part A (SAD) Cohorts: Pre-dose through Day 36
Area under the concentration-time curve from time 0 to infinity (hours*ng/mL)
Part A (SAD) Cohorts: Pre-dose through Day 36
Single-dose pharmacokinetic parameter- t½
Tidsramme: Part A (SAD) Cohorts: Pre-dose through Day 36
Terminal half-life (hours)
Part A (SAD) Cohorts: Pre-dose through Day 36
Multiple-dose pharmacokinetic parameter--Cmax
Tidsramme: Part B (MAD) Cohorts: Pre-dose through Day 93
Maximum observed serum concentration (ng/mL)
Part B (MAD) Cohorts: Pre-dose through Day 93
Multiple-dose pharmacokinetic parameter-Tmax
Tidsramme: Part B (MAD) Cohorts: Pre-dose through Day 93
Time at Cmax (hours)
Part B (MAD) Cohorts: Pre-dose through Day 93
Multiple-dose pharmacokinetic parameter-AUC0-∞
Tidsramme: Part B (MAD) Cohorts: Pre-dose through Day 93
Area under the concentration-time curve from time 0 to infinity (hours*ng/mL)
Part B (MAD) Cohorts: Pre-dose through Day 93
Multiple-dose pharmacokinetic parameter-t½
Tidsramme: Part B (MAD) Cohorts: Pre-dose through Day 93
Terminal half-life (hours)
Part B (MAD) Cohorts: Pre-dose through Day 93
Accumulation Ratio
Tidsramme: Part B (MAD) Cohorts: Pre-dose through Day 93
Accumulation ratio after last dose
Part B (MAD) Cohorts: Pre-dose through Day 93

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studieleder: Nadia Tchao, MD, Lycia Therapeutics, Inc.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

26. juni 2026

Primær fullføring (Antatt)

1. april 2028

Studiet fullført (Antatt)

1. april 2028

Datoer for studieregistrering

Først innsendt

25. juni 2026

Først innsendt som oppfylte QC-kriteriene

13. juli 2026

Først lagt ut (Faktiske)

14. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Phase 1 first-in-human study

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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