- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07935564
A Study to Assess the Adverse Events and How Oral ABBV-1606 Moves Through the Body of Healthy Adult Participants.
A First-in-Human Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABBV-1606 in Healthy Adult Subjects
This study will assess the adverse events, tolerability, and how oral ascending doses of ABBV-1606 moves through the body of healthy adult participants.
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: ABBVIE CALL CENTER
- Numéro de téléphone: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Lieux d'étude
-
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Illinois
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Grayslake, Illinois, États-Unis, 60030
- Acpru /Id# 277795
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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:
- BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- Total body weight > 50.0 kg at Screening.
- A condition of general good health, based upon the results of a medical history, physical examination, neurological examination, vital signs, laboratory profile, and a 12-lead ECG.
Exclusion Criteria:
- History of any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, immunological, neurological, pulmonary, metabolic, endocrine or psychiatric disease or disorder, active or chronic infectious diseases or any uncontrolled medical illness.
- History of any vasculitis-related conditions, or any confirmed autoimmune or connective tissue diseases (e.g., Systemic Lupus Erythematosus, Sjogren's Syndrome, inflammatory bowel disease, etc.) as per the Investigator judgement.
- History of unexplained purpura or skin rash, or unexplained signs or symptoms suggestive of vasculitis (including, but not limited to, fever, weight loss, arthralgia or arthritis, myalgia, hematuria, abdominal pain, gastrointestinal bleeding, etc.) that is not resolved for at least 30 days prior to dosing.
- History of any abnormal result for Antinuclear antibody (ANA) or Antineutrophil cytoplasmic antibody (ANCA) at Screening
- Abnormal result for C-Reactive Protein (CRP) or Erythrocyte Sedimentation Rate (ESR), or fibrinogen > the Upper limit of normal (ULN) at Screening.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: ABBV-1606 or Placebo Group 1
Participants will receive a single oral dose of ABBV-1606 or placebo group 1 on day 1. |
Oral Solution Oral Solution |
|
Expérimental: ABBV-1606 or Placebo Group 2
Participants will receive a single oral dose of ABBV-1606 or placebo group 2 on day 1. |
Oral Solution Oral Solution |
|
Expérimental: ABBV-1606 or Placebo Group 3
Participants will receive a single oral dose of ABBV-1606 or placebo group 3 on day 1. |
Oral Solution Oral Solution |
|
Expérimental: ABBV-1606 or Placebo Group 4
Participants will receive a single oral dose of ABBV-1606 or placebo group 4 on day 1. |
Oral Solution Oral Solution |
|
Expérimental: ABBV-1606 or Placebo Group 5
Participants will receive a single oral dose of ABBV-1606 or placebo group 5 on day 1. |
Oral Solution Oral Solution |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants Experiencing Adverse Events
Délai: Up to approximately 35 days
|
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment |
Up to approximately 35 days
|
|
Maximum observed plasma concentration (Cmax) of ABBV-1606
Délai: Up to approximately 5 days
|
Cmax of ABBV-1606 |
Up to approximately 5 days
|
|
Time to maximum observed plasma concentration (Cmax) (Tmax) of ABBV-1606
Délai: Up to approximately 5 days
|
Tmax of ABBV-1606 |
Up to approximately 5 days
|
|
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCt) of ABBV-1606
Délai: Up to approximately 5 days
|
AUCt of ABBV-1606 |
Up to approximately 5 days
|
|
Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of ABBV-1606
Délai: Up to approximately 5 days
|
AUCinf of ABBV-1606 |
Up to approximately 5 days
|
|
Apparent terminal phase elimination constant (β) of ABBV-1606
Délai: Up to approximately 5 days
|
β of ABBV-1606 |
Up to approximately 5 days
|
|
Terminal Phase Elimination Half-Life (t1/2) of ABBV-1606
Délai: Up to approximately 5 days
|
t1/2 of ABBV-1606 |
Up to approximately 5 days
|
|
Apparent clearance (CL/F) of ABBV-1606
Délai: Up to approximately 5 days
|
CL/F of ABBV-1606 |
Up to approximately 5 days
|
|
Apparent volume of distribution (Vz/F) of ABBV-1606
Délai: Up to approximately 5 days
|
Vz/F of ABBV-1606 |
Up to approximately 5 days
|
|
Dose Normalized Cmax of ABBV-1606
Délai: Up to approximately 5 days
|
Dose Normalized Cmax of ABBV-1606 will be assessed. |
Up to approximately 5 days
|
|
Dose Normalized AUC of ABBV-1606
Délai: Up to approximately 5 days
|
Dose Normalized AUC of ABBV-1606 will be assessed. |
Up to approximately 5 days
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: ABBVIE INC., AbbVie
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
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
Mots clés
Autres numéros d'identification d'étude
- M25-822
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
produit fabriqué et exporté des États-Unis.
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