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Table 2 Part A: treatment-emergent adverse events

From: A phase I, randomized, observer-blinded, single and multiple ascending-dose study to investigate the safety, pharmacokinetics, and immunogenicity of BITS7201A, a bispecific antibody targeting IL-13 and IL-17, in healthy volunteers

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

  1. Data are number of subjects (%). IV intravenous, SC subcutaneous, TEAE treatment emergent adverse event