- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04788017
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ziresovir in Healthy Subjects
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential Parallel Group, Single Ascending Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ziresovir in Healthy Subjects
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Up to 3 dose cohorts are planned. The ziresovir dose level of each cohort is determined based on the collective clinical and nonclinical data of ziresovir.
The proposed dose levels of Cohorts 1, 2 and 3 are 300 mg and up to 600 mg and up to 900 mg, respectively.
A total of up to 24 subjects will be randomized with 18 subjects to receive active drug and 6 subjects to receive placebo in a double-blind fashion. Eight subjects will be randomized in each dose cohort, with 6 subjects to receive active drug and 2 subjects o receive placebo.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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New Jersey
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Secaucus, New Jersey, États-Unis, 07094
- Frontage
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Capable of giving written informed consent and complying with study procedures;
- Between the ages of 18 and 55 years, inclusive;
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive and body weight not less than 50 kg;
- Female subjects must have a negative pregnancy test result at screening;
- Considered healthy by the Investigator, based on subject's reported medical history, full physical examination, 12-lead ECG, and vital signs;
- Willing and being able to adhere to study restrictions and to be confined at the Clinical Research Unit.
Exclusion Criteria:
- Clinically significant reported history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator;
- Poor venous access;
- Taken an investigational drug or participated in a clinical trial evaluating an investigational drug or device within 30 days (or 5 half-lives) prior to the study drug dose, whichever is longer;
- Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the study drug dose;
- Major surgery or hospitalization within 6 months prior to screening that in the Investigator's opinion would put the subject or study conduct at risk, or have any scheduled surgery or hospitalization during the study period;
- Any condition or finding that in the Investigator's opinion would put the subject or study conduct at risk if the subject were to participate in the study.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: ziresovir
The study drugs will be administered to subjects by CRU staff at approximately 8:00 a.m. (± 1 hour), following an overnight fast. Immediately following administration of the assigned dose of the study drugs, subjects will be given water such that their water consumption is approximately 240 mL as follows:
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Planned treatments are:
Autres noms:
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Comparateur placebo: placebo
The study drugs will be administered to subjects by CRU staff at approximately 8:00 a.m. (± 1 hour), following an overnight fast. Immediately following administration of the assigned dose of the study drugs, subjects will be given water such that their water consumption is approximately 240 mL as follows:
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Planned treatments are:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
numbers of all AEs
Délai: through study completion, an average of 22 days
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The Common Terminology Criteria for Adverse Events (CTCAE) Version 5 will be used to grade AEs
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through study completion, an average of 22 days
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percentages of all AEs
Délai: through study completion, an average of 22 days
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The Common Terminology Criteria for Adverse Events (CTCAE) Version 5 will be used to grade AEs
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through study completion, an average of 22 days
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change from baseline in systolic and diastolic blood pressure
Délai: screen/day -1/day 1/day 2/day 3/day4
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blood pressure in millimeter of mercury
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screen/day -1/day 1/day 2/day 3/day4
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change from baseline in pulse rate
Délai: screen/day -1/day 1/day 2/day 3/day4
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pulse rate in times per minute
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screen/day -1/day 1/day 2/day 3/day4
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change from baseline in respiratory rate
Délai: screen/day -1/day 1/day 2/day 3/day4
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respiratory rate in times per minute
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screen/day -1/day 1/day 2/day 3/day4
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change from baseline in oral temperature
Délai: screen/day -1/day 1/day 2/day 3/day4
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oral temperature in degree
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screen/day -1/day 1/day 2/day 3/day4
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change from baseline in Prothrombin time/International Normalized Ratio
Délai: screen/day -1/day 2/day4
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INR is calculated from the PT and allows for worldwide standardization of results.
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screen/day -1/day 2/day4
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change from baseline in Thrombin time
Délai: screen/day -1/day 2/day4
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Thrombin time in seconds
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screen/day -1/day 2/day4
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change from baseline in activated Partial Thromboplastin time
Délai: screen/day -1/day 2/day4
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activated Partial Thromboplastin time in seconds
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screen/day -1/day 2/day4
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change from baseline in Hemoglobin (Hgb) count
Délai: screen/day -1/day 2/day4
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Hemoglobin (Hgb) in gram per liter
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screen/day -1/day 2/day4
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change from baseline in Hematocrit (Hct)
Délai: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Platelet count
Délai: screen/day -1/day 2/day4
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Platelet count per liter
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screen/day -1/day 2/day4
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change from baseline in Red blood cell (RBC) count
Délai: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in White blood cell (WBC) count with differential
Délai: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Specific gravity from urinalysis
Délai: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in pH from urinalysis
Délai: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Protein from urinalysis
Délai: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Glucose from urinalysis
Délai: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Ketones from urinalysis
Délai: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Bilirubin from urinalysis
Délai: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
|
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change from baseline in Blood from urinalysis
Délai: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Nitrites from urinalysis
Délai: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Leukocytes from urinalysis
Délai: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in Urobilinogen from urinalysis
Délai: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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Incidence of abnormal Microscopic urine analysis
Délai: screen/day -1/day 2/day4
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screen/day -1/day 2/day4
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change from baseline in heart rate-corrected QT interval from resting 12-lead ECGs
Délai: screen/day -1/day1/day2/day4
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ECGs will be performed after the subject has been supine for at least 5 minutes
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screen/day -1/day1/day2/day4
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change from baseline in heart rate from resting 12-lead ECGs
Délai: screen/day -1/day1/day2/day4
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ECGs will be performed after the subject has been supine for at least 5 minutes
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screen/day -1/day1/day2/day4
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change from baseline in QRS intervals from resting 12-lead ECGs
Délai: screen/day -1/day1/day2/day4
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ECGs will be performed after the subject has been supine for at least 5 minutes
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screen/day -1/day1/day2/day4
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change from baseline in treatment-emergent T-wave morphology from resting 12-lead ECGs
Délai: screen/day -1/day1/day2/day4
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ECGs will be performed after the subject has been supine for at least 5 minutes
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screen/day -1/day1/day2/day4
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change from baseline in appearance of U-waves from resting 12-lead ECGs
Délai: screen/day -1/day1/day2/day4
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ECGs will be performed after the subject has been supine for at least 5 minutes
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screen/day -1/day1/day2/day4
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Incidence of abnormal physical findings
Délai: screen/day -1/day2/day3/day4
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full physical examination will be conducted at screening and an abbreviated physical exam will be conducted on Day -1 and Day 2. A symptom-directed physical exam will be conducted on Day 3 and Day 4.
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screen/day -1/day2/day3/day4
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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To characterize the drug concentration of ziresovir following single ascending doses by oral administration in healthy adult male and female subjects
Délai: 0 (within 90 minutes prior to dosing) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours post-dose
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0 (within 90 minutes prior to dosing) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours post-dose
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Jimmy Gu, Ark Biosciences
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
- AK0529-3001
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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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