Healthy Volunteers
Conditions
Brief summary
This is a double-blind, parallel group and placebo-controlled clinical study to assess safety tolerability, pharmacokinetics and pharmacodynamics of Atrosimab in healthy volunteers
Interventions
BIOLOGICALATM001
monovalent anti-TNF-receptor 1 antibody format
BIOLOGICALATM001 Placebo
ATM001 Placebo
Sponsors
Baliopharm Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy male subjects * body mass index 18-32 kg/m2 * normal physical examination, clinical laboratory values and ECG * additional inclusion criteria apply
Exclusion criteria
* febrile or infectious illness at least 7 days prior to the first administration * any active physical disease, acute or chronic * history of alcohol or drug abuse * history of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal, neurological, endocrinological, immunological, psychiatric, or cardio-vascular disease, myopathies and bleeding tendency * additional
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetic (PK): Area under the analyte concentration-time curve from time 0 and extrapolated to infinite time (AUC 0-∞) | 8 days |
| PK: Area under the plasma concentration curve from administration until the last quantifiable sampling point (AUC 0-t) | 8 days |
| PK: Maximum Plasma Concentration [Cmax] | 8 days |
| PK: Terminal half life (t1/2) | 8 days |
| PK: Apparent terminal elimination rate constant (λz) | 8 days |
| PK: Mean residence time (MRT) | 8 days |
| PK: Clearance (CL) | 8 days |
| PK: Apparent volume of distribution (Vz) | 8 days |
| Any adverse event, serious adverse event (SAE) | 4 weeks |
Countries
Australia
Outcome results
None listed