Safety Issues Clinical Trial
Official title:
A Phase 1, Randomised, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenously Administered AVLX-144
Verified date | July 2020 |
Source | Avilex Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | July 1, 2023 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Finland | Clinical Research Services Turku / CRST Oy | Turku |
Lead Sponsor | Collaborator |
---|---|
Avilex Pharma |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Pharmacokinetics parameter | AUClast (the area under the plasma concentration-time curve from time zero to the last sample with a quantifiable concentration) | From dosing until 48 hours after dosing | |
Secondary | Pharmacokinetics parameter | AUC0-24 (the area under the plasma concentration-time curve from time zero to 24 h), | 24 hrs | |
Secondary | Pharmacokinetics parameter AUC | AUCinf (the area under the plasma concentration-time curve from time zero extrapolated to infinity, if feasible) | From start to end of assessment | |
Secondary | Pharmacokinetics parameter elimination | elimination constant ?z and t½ (terminal elimination half-life, if feasible), and systemic plasma clearance (Cl) and volume of distribution (Vd) | From start to end of assessment |
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