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

Avilex Pharma

Status and phase: Completed; Phase 1

Conditions: Tolerance; Safety Issues

Treatments: Drug: AVLX-144; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04689035

AVLX-144CS01

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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46 participants in 6 patient groups

Cohort 1

Experimental group

Description:

AVLX-144_dose1

Treatment:

Drug: Placebo

Drug: AVLX-144

Cohort 2

Experimental group

Description:

AVLX-144_dose2

Treatment:

Drug: Placebo

Drug: AVLX-144

Cohort 3

Experimental group

Description:

AVLX-144_dose3

Treatment:

Drug: Placebo

Drug: AVLX-144

Cohort 4

Experimental group

Description:

AVLX-144_dose4

Treatment:

Drug: Placebo

Drug: AVLX-144

Cohort 5

Experimental group

Description:

AVLX-144_dose5

Treatment:

Drug: Placebo

Drug: AVLX-144

Cohort 6

Experimental group

Description:

AVLX-144_elderly

Treatment:

Drug: Placebo

Drug: AVLX-144