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Table 1 Demographic and baseline characteristics

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

Part A: Single ascending-dose cohorts

 

All Placebo

(n = 10)

All BITS7201A

(n = 31)

Cohort A 30-mg SC

(n = 8)

Cohort B 90-mg SC

(n = 8)

Cohort C 300-mg SC

(n = 8)

Cohort D 300-mg IV

(n = 9)

Cohort E 750-mg

IV (n = 8)

Age (years), mean (SD)

32.9 (10.75)

29.8 (9.82)

30.8 (11.41)

30.1 (10.76)

33.5 (10.64)

29.0 (10.59)

29.5 (8.40)

Sex, male, n (%),

5 (50.0)

16 (51.6)

4 (50.0)

4 (50.0)

4 (50.0)

3 (33.3)

6 (75.0)

Race, n (%)

 White

9 (90.0)

21 (67.7)

5 (62.5)

6 (75.0)

6 (75.0)

5 (55.6)

8 (100)

 Black or African American

1 (10.0)

9 (29.0)

3 (37.5)

2 (25.0)

2 (25.0)

3 (33.3)

0

 Multiple

0

1 (3.2)

0

0

0

1 (11.1)

0

Ethnicity, n (%)

 Hispanic or Latino

1 (10.0)

0

0

0

1 (12.5)

0

0

 Height (cm), mean (SD)

172.5 (7.62)

169.7 (10.01)

170.3 (9.21)

169.8 (11.66)

169.7 (7.34)

168.2 (10.48)

174.2 (9.40)

 Weight (kg), mean (SD)

77.9 (18.12)

78.8 (16.64)

80.3 (17.74)

83.3 (19.17)

75.8 (16.18)

77.2 (20.58)

76.5 (11.70)

 Body mass index (kg/m2), mean (SD)

26.2 (5.91)

27.3 (4.98)

27.6 (5.34)

28.7 (5.25)

26.4 (5.92)

27.1 (5.65)

25.3 (4.20)

Part B: Multiple ascending-dose cohorts

 

All Placebo (n = 6)

All BITS7201A (n = 20)

Cohort F 150-mg SC (n = 9)

Cohort G 300-mg SC (n = 8)

Cohort H 600-mg SC (n = 8)

Cohort Ia 600-mg SC (n = 1)

Age (years), mean (SD)

32.8 (8.82)

36.1 (11.00)

33.0 (10.07)

38.1 (9.28)

35.3 (13.16)

35.0

Sex n (%)

 Male

4 (66.7)

11 (55.0)

7 (77.8)

5 (62.5)

2 (25.0)

1 (100)

Race n (%)

 White

4 (66.7)

14 (70.0)

5 (55.6)

6 (75.0)

6 (75.0)

1 (100)

 Black or African American

2 (33.3)

5 (25.0)

3 (33.3)

2 (25.0)

2 (25.0)

0

 Multiple

0

1 (5.0)

1 (11.1)

0

0

0

Ethnicity n (%)

 Hispanic or Latino

1 (16.7)

1 (5.0)

1 (11.1)

1 (12.5)

0

0

 Height (cm), mean (SD)

169.4 (12.78)

169.8 (8.02)

169.8 (9.33)

174.1 (7.94)

164.5 (8.56)

174.0

 Weight (kg), mean (SD)

84.0 (23.99)

80.8 (15.34)

75.8 (14.88)

89.6 (17.30)

76.1 (15.15)

111.0

 Body mass index (kg/m2), mean (SD)

28.7 (4.48)

28.0 (4.90)

26.1 (3.61)

29.6 (5.24)

28.0 (4.40)

36.7

  1. IV intravenous, SC subcutaneous
  2. Number of subjects (n) for individual cohorts includes placebo subjects for that cohort
  3. aSubject with mild atopic asthma; standard deviations (SD) were not calculated for this cohort due to n=1