Status:
COMPLETED
A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144
Lead Sponsor:
Avilex Pharma
Conditions:
Safety Issues
Tolerance
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
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 ac...
Eligibility Criteria
Inclusion
- \- 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
- \- 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.
Key Trial Info
Start Date :
September 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04689035
Start Date
September 27 2020
End Date
July 1 2023
Last Update
July 20 2023
Active Locations (1)
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1
Clinical Research Services Turku / CRST Oy
Turku, Finland