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Completed

NCT Number: NCT04689035

A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144

This is a randomised, double-blind, placebo-controlled, single ascending dose study in healthy volunteer subjects. Each dose level will be investigated with eight 20-50-year-old male subjects (6 on active drug and 2 on placebo). Additionally, eight healthy elderly subjects (65-80 years of age, males and females), 6 on active drug and 2 on placebo, will be included in the study at one dose level, once the safety and tolerability of AVLX-144 has been documented in younger subjects.

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Key information

Conditions

Safety Issues Tolerance

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Research Services Turku / CRST Oy

Turku, Finland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and female subjects, body mass index (BMI) 18-28 kg/m2, body weight from 50 kg (females) or 60 kg (males) up to 100 kg, good general health.

Exclusion criteria

  • History or evidence of current clinically significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, haematological, metabolic-endocrine, neurological, urogenital or psychiatric disorder. Febrile convulsions in childhood do not necessarily exclude a subject, but subjects with any type of generalized seizure in adulthood must be excluded. Personal or first-degree family history of congenital long QT syndrome or sudden death of a first-degree relative suspected to be due to long QT syndrome will also exclude the subject.

Treatment and study plan

AVLX-144

Drug

Test drug

Other names: Test drug

Placebo

Drug

Placebo

Primary outcomes

  1. Safety and tolerability of AVLX-144

    Time frame: From randomisation to end of study participation

    Safety and tolerability will be assessed by recording adverse events (AEs), by performing physical examinations and safety laboratory assessments (blood and urine), and by recording vital signs and electrocardiograms (ECGs).

Secondary outcomes

  1. Pharmacokinetics parameter

    Time frame: From dosing until 48 hours after dosing

    AUClast (the area under the plasma concentration-time curve from time zero to the last sample with a quantifiable concentration)

  2. Pharmacokinetics parameter

    Time frame: 24 hrs

    AUC0-24 (the area under the plasma concentration-time curve from time zero to 24 h),

  3. Pharmacokinetics parameter AUC

    Time frame: From start to end of assessment

    AUCinf (the area under the plasma concentration-time curve from time zero extrapolated to infinity, if feasible)

  4. Pharmacokinetics parameter elimination

    Time frame: From start to end of assessment

    elimination constant λz and t½ (terminal elimination half-life, if feasible), and systemic plasma clearance (Cl) and volume of distribution (Vd)

Sponsors and collaborators

Lead sponsor

Avilex Pharma

Industry

Registry information

Official study title

A Phase 1, Randomised, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenously Administered AVLX-144

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 30, 2020
Registry last updated
Jul 20, 2023

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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