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Completed

NCT Number: NCT06406348

A Phase 1 Trial to Assess Safety, Tolerability and Pharmacokinetics of ALIA-1758 in Healthy Participants

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Worldwide Clinical Trials Early Phase Services, LLC

San Antonio, Texas, 78217, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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

Treatment and study plan

ALIA-1758

Drug

Intravenous or subcutaneous doses

Placebo

Other

Intravenous or subcutaneous doses

Primary outcomes

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

    Time frame: Up to 85 days after dosing

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

Secondary outcomes

  1. Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Cmax

    Time frame: 0-85 days after dosing

    Cmax

  2. Pharmacokinetic parameters of ALIA-1758 in healthy subjects: T1/2

    Time frame: 0-85 days after dosing

    elimination half-life (T1/2)

  3. Pharmacokinetic parameters of ALIA-1758 in healthy subjects: AUC

    Time frame: 0-85 days after dosing

    Area Under Curve (AUC)

  4. Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Bioavailability

    Time frame: 0-85 days after dosing

    Bioavailability after SC administration (F)

  5. Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Clearance

    Time frame: 0-85 days after dosing

    Clearance (CL)

  6. Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Volume of distribution

    Time frame: 0-85 days after dosing

    Volume of distribution (Vz)

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 9, 2024
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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