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Table 1 Study screening, evaluation, and exit procedures

From: A phase I, placebo-controlled, randomized, double-blind, single ascending dose-ranging study to evaluate the safety and tolerability of a novel biophysical bronchodilator (S-1226) administered by nebulization in healthy volunteers

Procedure Screening Study day 1 (check-in) Study day 1 (confinement) Study day 2 (checkout) Study exit (follow-up visit day 5 ± 1)
Demographic data X     
Medical and medication histories X     
Review of AEs and concomitant medications   X    X
Physical examination X X   X X
Height and weight X     
Vital signs X X Xa*   X
Tympanic temperature X X    X
Spirometryb X   Xc*   
Chest x-ray X     
ECG X   Xd*   X
Biochemistry X X Xe* X X
Hematology X X Xf* X X
HIV and hepatitis X     
Urinalysis X X   X X
Urine drug screen X X    
Urine cotinine test X X    
Alcohol breath test X X    
Serum pregnancy test X X    
Urine pregnancy test      X
Confinement   X X   
Drug administration    X   
PK blood sample    Xe* X  
PK urine sample (for perflubron measurements)    Xg* X  
Pulse oximetry X X Xa*   
Adverse event monitoring   X X X X
  1. AE adverse event, ECG electrocardiogram, PK pharmacokinetic
  2. * For study procedures scheduled at the same time point, the order of precedence is as follows:
  3. i. Blood draws (hematology and biochemistry)
  4. ii. ECG
  5. iii. Vital signs and pulse oximetry
  6. iv. Spirometry
  7. aBlood pressure, heart rate, respiratory rate, and pulse oximetry: predose and 20 minutes, 1 h, 2 h, 3 h, and 4 h postdose
  8. bFor screening, spirometry was forced expiratory volume in 1 second (FEV1) and forced vital capacity; for confinement, spirometry was FEV1 only
  9. cSpirometry within 1 h of drug administration (predose) and at 25 minutes, 1 h, 3 h, and 8 h (only if values before that are abnormal) after the end of study drug administration
  10. dECG predose and at 15 minutes, 1 h, 3 h, 4 h, and 8 h (only if values before that are abnormal) postdose
  11. eBiochemistry and PK blood samples were collected predose and at 3 minutes, 30 minutes, 1 h, 2 h, 4 h, 8 h, 12 h, and 24 h postdose
  12. fHematology was done predose and at 30 minutes, 2 h, 8 h, and 24 h postdose
  13. gUrine samples were collected over the following time intervals: predose and 0–4 h, 4–8 h, 8–12 h, and 12–24 h postdose