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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-27

Study Completion Date

2023-07-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Safety Issues Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

AVLX-144\_dose1

Group Type EXPERIMENTAL

AVLX-144

Intervention Type DRUG

Test drug

Placebo

Intervention Type DRUG

Placebo

Cohort 2

AVLX-144\_dose2

Group Type EXPERIMENTAL

AVLX-144

Intervention Type DRUG

Test drug

Placebo

Intervention Type DRUG

Placebo

Cohort 3

AVLX-144\_dose3

Group Type EXPERIMENTAL

AVLX-144

Intervention Type DRUG

Test drug

Placebo

Intervention Type DRUG

Placebo

Cohort 4

AVLX-144\_dose4

Group Type EXPERIMENTAL

AVLX-144

Intervention Type DRUG

Test drug

Placebo

Intervention Type DRUG

Placebo

Cohort 5

AVLX-144\_dose5

Group Type EXPERIMENTAL

AVLX-144

Intervention Type DRUG

Test drug

Placebo

Intervention Type DRUG

Placebo

Cohort 6

AVLX-144\_elderly

Group Type EXPERIMENTAL

AVLX-144

Intervention Type DRUG

Test drug

Placebo

Intervention Type DRUG

Placebo

Interventions

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AVLX-144

Test drug

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Test drug

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes