A Study to Assess the Safety, Tolerability and How Single Ascending Doses of ABBV-859 Moves Through the Body of Healthy Adult Participants

Официальное название

A First-in-Human, Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of ABBV-859 After Single Ascending Doses in Healthy Adult Subjects

Обзор

The objective of this study is to assess the pharmacokinetic (PK), immunogenicity, safety, and tolerability of ABBV-859 after single ascending doses in healthy adult volunteers.

Вмешательства

• Препарат ABBV-859
  Oral Tablet
• Препарат Placebo for ABBV-859
  Oral Tablet
• Препарат ABBV-859
  Intravenous (IV) Infusion
• Препарат Placebo for ABBV-859
  Intravenous (IV) Infusion

Первичные конечные точки

• Number of Participants with Adverse Events (AEs) [Срок оценки: Up to 99 Days]
• Maximum Observed Serum Concentration (Cmax) of ABBV-859 [Срок оценки: Up to 99 Days]
• Time to Cmax (Tmax) of ABBV-859 [Срок оценки: Up to 99 Days]
• Terminal Phase Elimination Rate Constant (Beta) of ABBV-859 [Срок оценки: Up to 99 Days]
• Terminal Phase Elimination Half-Life (t1/2) of ABBV-859 [Срок оценки: Up to 99 Days]
• Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-859 [Срок оценки: Up to 99 Days]
• AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-859 [Срок оценки: Up to 99 Days]
• Apparent Clearance (CL/F) ABBV-859 [Срок оценки: Up to 99 Days]
• Antidrug Antibody (ADA) [Срок оценки: Up to 99 Days]

Критерии участия

Критерии включения

• Participants must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
• Body Mass Index (BMI) is >= 18.0 to <= 32 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.
• A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead Electrocardiogram (ECG).

Критерии исключения

• History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, endocrine, immunological, pulmonary, metabolic, neurological or psychiatric disease or disorder, or any uncontrolled medical illness.
• History of any clinically significant sensitivity or allergy to any medication or food.
• History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption \[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\].
• Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.
• History or evidence of active Tuberculosis disease or latent Tuberculosis infection.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• CenExel ACT- Anaheim Clinical Trials /ID# 284382 — Anaheim
• Acpru /Id# 284029 — Grayslake

Идентификаторы

NCT: NCT07736638 · M25-924

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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