- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 1
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Head of Clinical Operations
- Numer telefonu: 650-392-3357
- E-mail: LCA-0061studyinquiry@lyciatx.com
Lokalizacje studiów
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Ontario
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Mississauga, Ontario, Kanada, L4W 1N2
- Rekrutacyjny
- CAN001
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Kontakt:
- Principal Investigator
- Numer telefonu: 650-392-3357
- E-mail: LCA-0061studyinquiry@lyciatx.com
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie sekwencyjne
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Part A - LCA-0061 (SAD)
Participants in cohorts 1-5 will receive single ascending dose levels of LCA-0061
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LCA-0061 is an antibody-based therapeutic designed to selectively bind and rapidly clear immunoglobulin E (IgE) via targeted degradation
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Eksperymentalny: Part B - LCA-0061 (MAD)
Participants in cohorts 1-4 will receive multiple ascending dose levels of LCA-0061
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LCA-0061 is an antibody-based therapeutic designed to selectively bind and rapidly clear immunoglobulin E (IgE) via targeted degradation
|
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Komparator placebo: Part A (SAD)
Participants in cohorts 1-5 will receive a single dose of Placebo
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Placebo
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Komparator placebo: Part B (MAD)
Participants in cohorts 1-4 will receive multiple doses of Placebo
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Placebo
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Occurrence of treatment-emergent adverse events (TEAEs)
Ramy czasowe: Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
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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
Ramy czasowe: 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
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|
Occurrence of TEAE by severity
Ramy czasowe: Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
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Percentage of participants with Common Terminology Criteria for Adverse Events (CTCAE) Grade 2, 3, 4 or 5 TEAE by cohort and treatment arm
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Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
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|
Occurrence of Clinically significant laboratory values, electrocardiograms (ECGs), and vital signs
Ramy czasowe: Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
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Percentage of participants, by cohort and treatment arm, with clinically significant abnormal laboratory values, ECGs, and vital signs
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Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Single-dose pharmacokinetic parameter- Cmax
Ramy czasowe: Part A (SAD) Cohorts: Pre-dose through Day 36
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Maximum observed serum concentration (ng/mL)
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Part A (SAD) Cohorts: Pre-dose through Day 36
|
|
Single-dose pharmacokinetic parameter- Tmax
Ramy czasowe: Part A (SAD) Cohorts: Pre-dose through Day 36
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Time at Cmax (hours)
|
Part A (SAD) Cohorts: Pre-dose through Day 36
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Single-dose pharmacokinetic parameter-AUC0-∞
Ramy czasowe: Part A (SAD) Cohorts: Pre-dose through Day 36
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Area under the concentration-time curve from time 0 to infinity (hours*ng/mL)
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Part A (SAD) Cohorts: Pre-dose through Day 36
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Single-dose pharmacokinetic parameter- t½
Ramy czasowe: Part A (SAD) Cohorts: Pre-dose through Day 36
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Terminal half-life (hours)
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Part A (SAD) Cohorts: Pre-dose through Day 36
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Multiple-dose pharmacokinetic parameter--Cmax
Ramy czasowe: Part B (MAD) Cohorts: Pre-dose through Day 93
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Maximum observed serum concentration (ng/mL)
|
Part B (MAD) Cohorts: Pre-dose through Day 93
|
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Multiple-dose pharmacokinetic parameter-Tmax
Ramy czasowe: Part B (MAD) Cohorts: Pre-dose through Day 93
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Time at Cmax (hours)
|
Part B (MAD) Cohorts: Pre-dose through Day 93
|
|
Multiple-dose pharmacokinetic parameter-AUC0-∞
Ramy czasowe: 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
Ramy czasowe: Part B (MAD) Cohorts: Pre-dose through Day 93
|
Terminal half-life (hours)
|
Part B (MAD) Cohorts: Pre-dose through Day 93
|
|
Accumulation Ratio
Ramy czasowe: Part B (MAD) Cohorts: Pre-dose through Day 93
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Accumulation ratio after last dose
|
Part B (MAD) Cohorts: Pre-dose through Day 93
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Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Nadia Tchao, MD, Lycia Therapeutics, Inc.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- LCA-0061-01
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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