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

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

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.

Study Overview

• Status: Completed
• Conditions: Tolerance; Safety Issues
• Intervention / Treatment: Drug: Placebo; Drug: AVLX-144

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland
    • Clinical Research Services Turku / CRST Oy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; AVLX-144_dose1	Drug: Placebo; Placebo; Drug: AVLX-144; Test drug; Other Names: Test drug
Experimental: Cohort 2; AVLX-144_dose2	Drug: Placebo; Placebo; Drug: AVLX-144; Test drug; Other Names: Test drug
Experimental: Cohort 3; AVLX-144_dose3	Drug: Placebo; Placebo; Drug: AVLX-144; Test drug; Other Names: Test drug
Experimental: Cohort 4; AVLX-144_dose4	Drug: Placebo; Placebo; Drug: AVLX-144; Test drug; Other Names: Test drug
Experimental: Cohort 5; AVLX-144_dose5	Drug: Placebo; Placebo; Drug: AVLX-144; Test drug; Other Names: Test drug
Experimental: Cohort 6; AVLX-144_elderly	Drug: Placebo; Placebo; Drug: AVLX-144; Test drug; Other Names: Test drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Pharmacokinetics parameter	AUC0-24 (the area under the plasma concentration-time curve from time zero to 24 h),	24 hrs
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
Pharmacokinetics parameter elimination	elimination constant λz and t½ (terminal elimination half-life, if feasible), and systemic plasma clearance (Cl) and volume of distribution (Vd)	From start to end of assessment

Collaborators and Investigators

• Sponsor: Avilex Pharma
• Investigators: Principal Investigator: Mika Scheinin, MD, Clinical Research Services Turku - CRST Oy

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2020
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 28, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: AVLX-144CS01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No