- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07701954
Single Ascending and Multiple Ascending Dose Study of LCA-0061
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Head of Clinical Operations
- Numéro de téléphone: 650-392-3357
- E-mail: LCA-0061studyinquiry@lyciatx.com
Lieux d'étude
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Ontario
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Mississauga, Ontario, Canada, L4W 1N2
- Recrutement
- CAN001
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Contact:
- Principal Investigator
- Numéro de téléphone: 650-392-3357
- E-mail: LCA-0061studyinquiry@lyciatx.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Key Inclusion Criteria: Part A (SAD) and Part B (MAD)
- 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
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
Key Exclusion Criteria: Part A and B
- Pregnant or lactating
History of clinically relevant underlying comorbidities including:
- chronic obstructive pulmonary disease
- myocardial infarction
- chronic heart failure or unstable angina pectoris
- hyperlipidemia
- 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
|
Expérimental: 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
|
|
Comparateur placebo: Part A (SAD)
Participants in cohorts 1-5 will receive a single dose of Placebo
|
Placebo
|
|
Comparateur placebo: Part B (MAD)
Participants in cohorts 1-4 will receive multiple doses of Placebo
|
Placebo
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Occurrence of treatment-emergent adverse events (TEAEs)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Single-dose pharmacokinetic parameter- Cmax
Délai: 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
Délai: 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-∞
Délai: 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
Délai: 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
Délai: 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
Délai: 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-∞
Délai: 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
Délai: Part B (MAD) Cohorts: Pre-dose through Day 93
|
Terminal half-life (hours)
|
Part B (MAD) Cohorts: Pre-dose through Day 93
|
|
Accumulation Ratio
Délai: Part B (MAD) Cohorts: Pre-dose through Day 93
|
Accumulation ratio after last dose
|
Part B (MAD) Cohorts: Pre-dose through Day 93
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Nadia Tchao, MD, Lycia Therapeutics, Inc.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- LCA-0061-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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