Table 1.

Summary of dosing and PK sampling study design

Study name	Dosing regimens	Participants/patients (n)	Samples (n) and collection time
NCT01015027 (R668‐AS‐0907): Ascending dose study of the safety and tolerability of REGN668 (SAR231893) in normal healthy volunteers7	Single i.v. infusions of 1, 3, 8, and 12 mg/kg, Single s.c. injections of 150 and 300 mg	36	508, days 1 (hours 0, 1, 2, 4, 8), 2, 4, 8, 11, 15, 22, 29, 43, 57, 85
NCT01259323 (R668‐AD‐0914): Sequential ascending dose study to assess the safety and tolerability of REGN668 (SAR231893) in patients with atopic dermatitis 1	4 s.c. injections of 75, 150, or 300 mg qw	24	279, days 4, 8, 15, 22, 25, 29, 36, 43, 50, 57, 64, 71, 85
NCT01385657 (R668‐AD‐1026): Safety and tolerability of REGN668 (SAR231893) in patients with moderate to severe atopic dermatitis1	4 s.c. injections 150 or 300 mg qw	27	312, days 4, 8, 15, 22, 25, 29, 36, 43, 50, 57, 64, 71, 85
NCT01484600 (R668‐HV‐1108): Study of the safety, tolerability, pharmacokinetics, and immunogenicity of REGN668 administered subcutaneously to healthy volunteers	Single s.c. injections of 300 mg	36	564, days 1 (hours 0, 1, 2, 4, 8, 12), 2, 4, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64
NCT01548404 (R668‐AD‐1117): Study of REGN668/SAR231893 in adult patients with extrinsic moderate‐to‐severe atopic dermatitis1	12 s.c. injections of 300 mg qw	53	693, days 8, 15, 22, 29, 43, 57, 71, 78, 85, 99, 113, 127, 141, 155, 169, 183, 197
NCT01639040 (R668‐AD‐1121): Study to assess the safety of REGN668 (SAR231893) administered concomitantly with topical corticosteroids (TCS) in patients with moderate‐to‐severe atopic dermatitis (AD)1	4 s.c. injections of 100 or 300 mg qw	21	162, days 8, 15, 22, 29, 36, 50, 64, 78

AD, atopic dermatitis; i.v., intravenous; s.c., subcutaneous.