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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04689035
Other study ID # AVLX-144CS01
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 27, 2020
Est. completion date July 1, 2023

Study information

Verified date July 2020
Source Avilex Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date July 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AVLX-144
Test drug
Placebo
Placebo

Locations

Country Name City State
Finland Clinical Research Services Turku / CRST Oy Turku

Sponsors (1)

Lead Sponsor Collaborator
Avilex Pharma

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and tolerability of AVLX-144 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). From randomisation to end of study participation
Secondary Pharmacokinetics parameter AUClast (the area under the plasma concentration-time curve from time zero to the last sample with a quantifiable concentration) From dosing until 48 hours after dosing
Secondary Pharmacokinetics parameter AUC0-24 (the area under the plasma concentration-time curve from time zero to 24 h), 24 hrs
Secondary Pharmacokinetics parameter AUC AUCinf (the area under the plasma concentration-time curve from time zero extrapolated to infinity, if feasible) From start to end of assessment
Secondary Pharmacokinetics parameter elimination elimination constant ?z and t½ (terminal elimination half-life, if feasible), and systemic plasma clearance (Cl) and volume of distribution (Vd) From start to end of assessment
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