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L'essai clinique NCT06294288 pour Urticaire spontanée chronique est actif, pas en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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A Study of Single and Multiple Doses of LP-003 in Healthy Adult Participants
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L'essai clinique NCT06294288 est conçu pour étudier le treatment de Urticaire spontanée chronique. Il s'agit d'un essai interventionnel en Phase I. Son statut actuel est : actif, pas en recrutement. L'essai a débuté le 1 juillet 2021 et vise à recruter 70 participants. Dirigé par Longbio Pharma, l'essai devrait être terminé d'ici le 15 mars 2024. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 5 mars 2024.
Résumé succinct
The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-003 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-003 and Part 2, multiple ascending dose (MAD).
Titre officiel
To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Single and Multiple Doses of LP-003 in Healthy Volunteers
Conditions
Urticaire spontanée chroniqueAutres identifiants de l'essai
- P-10-LP003-2022-01
Numéro NCT
Date de début (réel)
2021-07-01
Dernière mise à jour publiée
2024-03-05
Date de fin (estimée)
2024-03-15
Inscription (estimée)
70
Type d'essai
Interventionnel
PHASE
Phase I
Statut
Actif, pas en recrutement
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Triple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalCohort 1: LP-003 Dose 1 (Single) | LP-003 Dose 1 (Single) A single dose of LP-003 (Dose 1) was administered intravenously. |
ExpérimentalCohort 2: LP-003 Dose 2 (Single) | LP-003 Dose 2 (Single) A single dose of LP-003 (Dose 2) was administered intravenously. |
ExpérimentalCohort 3: LP-003 Dose 3 (Single) | LP-003 Dose 3 (Single) A single dose of LP-003 (Dose 3) was administered intravenously. |
ExpérimentalCohort 4: LP-003 Dose 4 (Single) | LP-003 Dose 4 (Single) A single dose of LP-003 (Dose 4) was administered intravenously. |
ExpérimentalCohort 5: LP-003 Dose 5 (Single) | LP-003 Dose 5 (Single) A single dose of LP-003 (Dose 5) was administered intravenously. |
Comparateur placeboCohort 6: Placebo (Single) | Placebo (Single) A single dose of placebo was administered intravenously. |
ExpérimentalCohort 7: LP-003 Dose 6 (Multiple) | LP-003 Dose 6 (Multiple) LP-003 (Dose 6) was administered multiple times subcutaneously. |
ExpérimentalCohort 8: LP-003 Dose 7 (Multiple) | LP-003 Dose 7 (Multiple) LP-003 (Dose 7) was administered multiple times subcutaneously. |
ExpérimentalCohort 9: LP-003 Dose 8 (Multiple) | LP-003 Dose 8 (Multiple) LP-003 (Dose 8) was administered multiple times subcutaneously. |
Comparateur placeboCohort 10: Placebo (Multiple) | Placebo (Multiple) Placebo was administered multiple times subcutaneously. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Adverse events | Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs). | Observation for 280 days after administration |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Time to peak concentration (Tmax) of LP-003 | The time when the blood drug concentration reaches its peak after a single dose of medication. | Observation for 280 days after administration |
Maximum concentration (Cmax) of LP-003 | The maximum concentration of LP-003 in the bloodstream after administration. | Observation for 280 days after administration |
Elimination half-life (t1/2) of LP-003 | The time required for the concentration of LP-003 in the bloodstream to decrease by half. | Observation for 280 days after administration |
Area under the concentration-time curve (AUC0-t) of LP-003 | The area under the concentration-time curve (AUC) from time zero to the last chosen time point represents the integral of the drug concentration in the bloodstream over the specified duration. | Observation for 280 days after administration |
Apparent clearance rate (CL/F) of LP-003 | The ratio of drug clearance to drug concentration, represents the apparent clearance of a drug after administration, adjusted for bioavailability. | Observation for 280 days after administration |
Assessment of immunogenicity | The proportion of anti drug antibody (ADA) positive subjects at different detection time points. | Observation for 280 days after administration |
Assessment of total immunoglobulin E (IgE) | The changes in serum total immunoglobulin E (IgE) levels compared to baseline at different assessment time points. | Observation for 168 days after administration |
Assessment of free IgE | The changes in serum free IgE levels compared to baseline at different assessment time points. | Observation for 168 days after administration |
Critères d'éligibilité
Âges éligibles
Adulte
Âge minimum
18 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
- Healthy males or females aged 18 through 50 years
- Male subjects must weigh ≥50 kg, and female subjects must weigh ≥45 kg, with a BMI between 19.0 and 28.0 kg/m² (inclusive).
- Male subjects and their partners or female subjects must agree to use one or more non-pharmaceutical contraceptive methods (such as total abstinence, condoms, Iuds, partner ligation, etc.) during the trial period and for 6 months after the trial, and do not plan to donate sperm or eggs.
- The subjects fully understand the purpose, nature, method and possible adverse reactions of the experiment, and voluntarily participate in the experiment and sign the informed consent.
- The subjects were able to communicate well with the researchers and complete the study according to the protocol.
- People who are allergic to the experimental drug and any of its excipients, have a history of allergy to monoclonal antibodies, and are allergic to multiple drugs and food.
- Patients who have been or are currently suffering from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatric and metabolic abnormalities, or any other diseases that can interfere with the test results.
- Patients who had undergone surgery within 3 months before the trial that the researchers judged would affect drug absorption, distribution, metabolism, and excretion, or had surgery within 4 weeks prior to the trial, or planned to have surgery during the study period.
- Any history of infection within 14 days prior to administration.
- A person who is currently infected with parasites or has traveled to an endemic area within the last 3 months or 24 weeks prior to administration.
- Pregnant and lactating women.
- Hepatitis B surface antigen, hepatitis C virus antibodies, human immunodeficiency virus antibodies, treponema pallidum antibodies A positive person.
- Patients who have received any biological agent (including antibodies or derivatives such as omalizumab) within 16 weeks prior to administration (or 5 half-lives, selecting the longer time period).
- Participants who had participated in other clinical trials within 3 months prior to screening.
- The investigator deems any condition unsuitable for study participation.
Longbio PharmaAucune donnée de contact disponible
1 Centres de l'essai dans 1 pays
Shanghai Municipality
Shanghai General Hospital, Shanghai, Shanghai Municipality, China