临床试验/NCT06406348

NCT06406348已完成1 期

A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Single Ascending Dose Trial to Assess the Safety, Tolerability and Pharmacokinetic Effects of ALIA-1758 in Healthy Participants

AbbVie1 个研究点分布在 1 个国家目标入组 53 人开始时间: 2024年5月9日最近更新: 2025年7月17日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 53
试验地点: 1
主要终点: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

This is a Phase 1, first in human (FIH), double-blind, placebo-controlled, single ascending dose (SAD) trial to assess the safety, tolerability, and pharmacokinetics (PK) of intravenously (IV) or subcutaneously (SC) injected ALIA-1758 in healthy male and female participants.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 40 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Participants must understand the nature of the trial and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any trial-related procedures.
•Healthy as determined by the Investigator, based on a medical evaluation including medical history, physical examination, laboratory tests and electrocardiogram (ECG) recording. A participant with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if, in the opinion of the Investigator, the finding is (a) unlikely to introduce additional risk to the participant, (b) will not interfere with trial procedures or confound trial results, and (c) is not otherwise exclusionary (see Exclusion Criteria).
•Body weight of at least 50.0 kg for men and 45.0 kg for women and Body Mass Index (BMI) within the range of 17.5-32.0 kg/m2 (inclusive) at Screening.

排除标准

•A history or presence of a clinically significant hepatic, biliary, renal, gastrointestinal, cardiovascular, endocrine, pulmonary, ophthalmologic, immunologic, hematologic, dermatologic, psychiatric, neurologic abnormality, or chronic urinary tract infections.
•A clinically significant abnormality on physical examination, ECG, or laboratory evaluations at Screening or between Screening and (first) dose administration.
•The participant is, in the opinion of the Investigator or Medical Monitor, unlikely to comply with the protocol or is unsuitable for any reason.
•Other criteria may apply

研究组 & 干预措施

Active

Experimental

Single Ascending Dose (SAD) cohorts

干预措施: ALIA-1758 (Drug)

Placebo

Placebo Comparator

Single Ascending Dose (SAD) cohorts

干预措施: Placebo (Other)

结局指标

主要结局

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

时间窗: Up to 85 days after dosing

Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs)

次要结局

Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Cmax(0-85 days after dosing)
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: T1/2(0-85 days after dosing)
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: AUC(0-85 days after dosing)
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Bioavailability(0-85 days after dosing)
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Clearance(0-85 days after dosing)
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Volume of distribution(0-85 days after dosing)

研究者

发起方

AbbVie

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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