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

NCT04689035 | Completed Phase 1 DMC

• 1 other identifier: AVLX-144CS01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Safety Issues; Tolerance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pharmacokinetics parameter

  From dosing until 48 hours after dosing

• Pharmacokinetics parameter

  24 hrs

• Pharmacokinetics parameter AUC

  From start to end of assessment

• Pharmacokinetics parameter elimination

  From start to end of assessment

Study Arms (6)

Cohort 1

EXPERIMENTAL

AVLX-144\_dose1

Drug: AVLX-144; Drug: Placebo

Cohort 2

EXPERIMENTAL

AVLX-144\_dose2

Drug: AVLX-144; Drug: Placebo

Cohort 3

EXPERIMENTAL

AVLX-144\_dose3

Drug: AVLX-144; Drug: Placebo

Cohort 4

EXPERIMENTAL

AVLX-144\_dose4

Drug: AVLX-144; Drug: Placebo

Cohort 5

EXPERIMENTAL

AVLX-144\_dose5

Drug: AVLX-144; Drug: Placebo

Cohort 6

EXPERIMENTAL

AVLX-144\_elderly

Drug: AVLX-144; Drug: Placebo

Interventions

AVLX-144 DRUG

Test drug

Also known as: Test drug

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6

Placebo DRUG

Placebo

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Avilex Pharma: lead

Study Sites (1)

Clinical Research Services Turku / CRST Oy

Turku, Finland

Location

MeSH Terms

Interventions

Drug Evaluation

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

• Mika Scheinin, MD

  Clinical Research Services Turku - CRST Oy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 30, 2020
• Study Start: September 27, 2020
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: July 20, 2023

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)