System Organ Class Preferred Term | All Placebo (n = 10) | All BITS7201A (n = 31) | Cohort A 30-mg SC (n = 6) | Cohort B 90-mg SC (n = 6) | Cohort C 300-mg SC (n = 6) | Cohort D 300-mg IV (n = 7) | Cohort E 750-mg IV (n = 6) |
---|---|---|---|---|---|---|---|
Total number of TEAEs | 8 | 15 | 4 | 1 | 3 | 3 | 4 |
Number of subjects with at least 1 TEAE | 5 (50.0) | 12 (38.7) | 2 (33.3) | 1 (16.7) | 3 (50.0) | 3 (42.9) | 3 (50.0) |
General disorders and administration site conditions | 1 (10.0) | 5 (16.1) | 1 (16.7) | 0 | 2 (33.3) | 1 (14.3) | 1 (16.7) |
 Fatigue | 0 | 3 (9.7) | 1 (16.7) | 0 | 1 (16.7) | 1 (14.3) | 0 |
 Chills | 1 (10.0) | 0 | 0 | 0 | 0 | 0 | 0 |
 Infusion site erythema | 0 | 1 (3.2) | 0 | 0 | 0 | 0 | 1 (16.7) |
 Injection site reaction | 0 | 1 (3.2) | 0 | 0 | 1 (16.7) | 0 | 0 |
Infections and infestations | 1 (10.0) | 4 (12.9) | 1 (16.7) | 0 | 0 | 2 (28.6) | 1 (16.7) |
 Chlamydial infection | 0 | 1 (3.2) | 0 | 0 | 0 | 1 (14.3) | 0 |
 Furuncle | 0 | 1 (3.2) | 1 (16.7) | 0 | 0 | 0 | 0 |
 Otitis media | 0 | 1 (3.2) | 0 | 0 | 0 | 0 | 1 (16.7) |
 Pharyngitis streptococcal | 0 | 1 (3.2) | 0 | 0 | 0 | 1 (14.3) | 0 |
 Upper respiratory tract infection | 0 | 1 (3.2) | 0 | 0 | 0 | 0 | 1 (16.7) |
 Viral upper respiratory tract infection | 1 (10.0) | 0 | 0 | 0 | 0 | 0 | 0 |
Gastrointestinal disorders | 2 (20.0) | 1 (3.2) | 0 | 0 | 1 (16.7) | 0 | 0 |
 Abdominal pain upper | 0 | 1 (3.2) | 0 | 0 | 1 (16.7) | 0 | 0 |
 Nausea | 1 (10.0) | 0 | 0 | 0 | 0 | 0 | 0 |
 Vomiting | 1 (10.0) | 0 | 0 | 0 | 0 | 0 | 0 |
Ear and labyrinth disorders | 1 (10.0) | 1 (3.2) | 1 (16.7) | 0 | 0 | 0 | 0 |
 Cerumen impaction | 0 | 1 (3.2) | 1 (16.7) | 0 | 0 | 0 | 0 |
 Ear pain | 1 (10.0) | 0 | 0 | 0 | 0 | 0 | 0 |
Respiratory, thoracic and mediastinal disorders | 1 (10.0) | 1 (3.2) | 0 | 0 | 0 | 0 | 1 (16.7) |
 Oropharyngeal pain | 0 | 1 (3.2) | 0 | 0 | 0 | 0 | 1 (16.7) |
 Rhinorrhoea | 1 (10.0) | 0 | 0 | 0 | 0 | 0 | 0 |
Injury, poisoning and procedural complications | 0 | 1 (3.2) | 1 (16.7) | 0 | 0 | 0 | 0 |
 Ligament sprain | 0 | 1 (3.2) | 1 (16.7) | 0 | 0 | 0 | 0 |
Nervous system disorders | 1 (10.0) | 0 | 0 | 0 | 0 | 0 | 0 |
 Dizziness | 1 (10.0) | 0 | 0 | 0 | 0 | 0 | 0 |
 Psychiatric disorders | 0 | 1 (3.2) | 0 | 1 (16.7) | 0 | 0 | 0 |
 Libido decreased | 0 | 1 (3.2) | 0 | 1 (16.7) | 0 | 0 | 0 |
Skin and subcutaneous tissue disorders | 1 (10.0) | 0 | 0 | 0 | 0 | 0 | 0 |
 Dermatitis contact | 1 (10.0) | 0 | 0 | 0 | 0 | 0 | 0 |