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

Phase 1

Completed

• Conditions: Safety Issues; Tolerance
• Interventions: Drug: AVLX-144; Drug: Placebo

• Registration Number: NCT04689035
• Lead Sponsor: Avilex Pharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study Start: 2020-09-27
• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-28
• Study First Posted: 2020-12-30
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 4	Placebo	AVLX-144_dose4
Cohort 5	AVLX-144	AVLX-144_dose5
Cohort 5	Placebo	AVLX-144_dose5
Cohort 1	AVLX-144	AVLX-144_dose1
Cohort 1	Placebo	AVLX-144_dose1
Cohort 2	AVLX-144	AVLX-144_dose2
Cohort 6	AVLX-144	AVLX-144_elderly
Cohort 2	Placebo	AVLX-144_dose2
Cohort 3	AVLX-144	AVLX-144_dose3
Cohort 3	Placebo	AVLX-144_dose3
Cohort 4	AVLX-144	AVLX-144_dose4
Cohort 6	Placebo	AVLX-144_elderly

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of AVLX-144	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 Outcome Measures

Name	Time	Method
Pharmacokinetics parameter	24 hrs	AUC0-24 (the area under the plasma concentration-time curve from time zero to 24 h),
Pharmacokinetics parameter AUC	From start to end of assessment	AUCinf (the area under the plasma concentration-time curve from time zero extrapolated to infinity, if feasible)
Pharmacokinetics parameter elimination	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)

Trial Locations

Locations (1)

Clinical Research Services Turku / CRST Oy; 🇫🇮 Turku, Finland