A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ABBV-243 in Healthy Adults.

Официальное название

A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Single Ascending Doses (SAD) of ABBV-243 in Healthy Adult Subjects and a Single Dose in Healthy Asian Adult Subjects

Обзор

The objective of this study is to assess the safety, tolerability, pharmacokinetics and immunogenicity of either single ascending intravenous (IV) doses of ABBV-243 or single ascending subcutaneous (SC) doses of ABBV-243 in healthy adult participants (Part 1), and a single intravenous (IV) dose in healthy Asian adult volunteers (Part 2 There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Вмешательства

• Препарат ABBV-243
  Intravenous (IV) Infusion
• Препарат Placebo
  Intravenous (IV) Infusion
• Препарат ABBV-243
  Subcutaneous (SC) Injection
• Препарат Placebo
  Subcutaneous (SC) Injection

Первичные конечные точки

• Number of Participants with Adverse Events (AEs) [Срок оценки: Up to Day 204]
• Maximum Observed Serum Concentration (Cmax) of ABBV-243 [Срок оценки: Up to Day 204]
• Time to Cmax (Tmax) of ABBV-243 [Срок оценки: Up to Day 204]
• Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-243 [Срок оценки: Up to Day 204]
• Area Under the Serum Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-243 [Срок оценки: Up to Day 204]
• Terminal Phase Elimination Rate Constant (β) of ABBV-243 [Срок оценки: Up to Day 204]
• Terminal Phase Elimination Half-Life (t1/2) of ABBV-243 [Срок оценки: Up to Day 204]
• Anti-Drug Antibody (ADA) of ABBV-243 [Срок оценки: Up to Day 204]

Критерии участия

Критерии включения

• Individuals between 18 and 60 years of age inclusive at the time of Screening.
• BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenth's decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
• Females, Non-Childbearing Potential are eligible as defined by meeting the following criteria:

• Permanent sterility due to a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
• Non-surgical permanent infertility due to Mullerian agenesis, androgen insensitivity, or gonadal dysgenesis; investigator discretion should be applied to determining study entry.
• Postmenopausal female who is age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND an FSH level ≥ 30 IU/L.
• Postmenopausal female who is age > 55 years with no menses for 12 or more months without an alternative medical cause.
• Females, Childbearing Potential are defined as all other females who do not meet the above criteria and must adhere to the following:

• Must not be pregnant or breastfeeding.
• Must agree to avoid pregnancy while taking study treatment(s) and for at least 200 days after the last dose of study treatment.
• Must agree to use a contraceptive method listed below (as per local regulations) that is highly effective (with a failure rate of < 1% per year, when used consistently and correctly). Participants must provide documentation to the site.
• Bilateral tubal occlusion/ligation.
• Intrauterine device (IUD) to be inserted at least 30 days prior to Screening.
• Intrauterine hormone-releasing system (IUS) to be inserted at least 30 days prior to Screening.
• Part 2 only:

Healthy Japanese and Han Chinese male or female; between 18 and 60 years of age, inclusive at the time of Screening.

\- Han Chinese participants must be first- or second-generation Han Chinese of full Chinese parentage. First-generation participants are defined as those born in China to two parents and four grandparents also born in China of full Chinese descent. Second-generation participants are defined as those born outside of China to two parents and four grandparents born in China of full Chinese descent.

OR

\- Japanese participants must be first- or second-generation Japanese of full Japanese parentage. First-generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation subjects born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent.

Критерии исключения

• History: of epilepsy, any clinically significant cardiovascular, respiratory (except mild asthma as a child), renal, endocrine, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
• History of any clinically significant sensitivity or allergy to any medication or food.
• 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 (TB) disease or latent TB 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

Фундаментальное исследование

Центры проведения

США · 1 центр

• Acpru /Id# 279789 — Grayslake

Идентификаторы

NCT: NCT07306754 · M25-776

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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