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

Safety Issues Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04689035
• Other study ID #: AVLX-144CS01
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Safety Issues
• Tolerance

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