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
Overview
- Phase
- Phase 1
- Intervention
- AVLX-144
- Conditions
- Safety Issues
- Sponsor
- Avilex Pharma
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Safety and tolerability of AVLX-144
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Cohort 1
AVLX-144_dose1
Intervention: AVLX-144
Cohort 1
AVLX-144_dose1
Intervention: Placebo
Cohort 4
AVLX-144_dose4
Intervention: AVLX-144
Cohort 4
AVLX-144_dose4
Intervention: Placebo
Cohort 2
AVLX-144_dose2
Intervention: AVLX-144
Cohort 2
AVLX-144_dose2
Intervention: Placebo
Cohort 3
AVLX-144_dose3
Intervention: AVLX-144
Cohort 3
AVLX-144_dose3
Intervention: Placebo
Cohort 5
AVLX-144_dose5
Intervention: AVLX-144
Cohort 5
AVLX-144_dose5
Intervention: Placebo
Cohort 6
AVLX-144_elderly
Intervention: AVLX-144
Cohort 6
AVLX-144_elderly
Intervention: Placebo
Outcomes
Primary Outcomes
Safety and tolerability of AVLX-144
Time Frame: From randomisation to end of study participation
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).
Secondary Outcomes
- Pharmacokinetics parameter(24 hrs)
- Pharmacokinetics parameter AUC(From start to end of assessment)
- Pharmacokinetics parameter elimination(From start to end of assessment)