Table 3a. Study schedule – single dosing regimen.
| Activity | Screening (Day -28 to Day -2) | Randomisation (Day -27 to Day -2) | Day -1 | Day 0 | Day 1 | Day 2 | Day 5 | Day 42 | 6-month telephone visit |
|---|---|---|---|---|---|---|---|---|---|
| In-patient stay | |||||||||
| Informed consent | |||||||||
| Inclusion/exclusion criteria | |||||||||
| Demographic data (including smoking history) | |||||||||
| Medical history | |||||||||
| Viral serology | |||||||||
| Pregnancy test a | |||||||||
| Provide results to investigations | |||||||||
| Randomization | |||||||||
| Study residency: | |||||||||
| Check in | |||||||||
| Check out | b | ||||||||
| Non-residential visit | |||||||||
| Study drug administration | |||||||||
| Safety and tolerability: c | |||||||||
| Adverse event recording d | |||||||||
| Vital signs (including blood pressure and pulse rate) | |||||||||
| Axillary body temperature | |||||||||
| 12 lead ECG e | |||||||||
| Clinical laboratory evaluations (including haematology, clinical chemistry, and urinalysis) | |||||||||
| Body weight (and height at first visit) | |||||||||
| Physical examination | |||||||||
| Concomitant medication | |||||||||
| Blood sampling | |||||||||
| Pharmacokinetics: | |||||||||
| Pharmacodynamics: |