A two-part, phase 1 single-dose study to assess doses of IL-31 mAb

• Research type

  Research Study

• Full title

  A Two-Part, Phase 1, Randomized, Single-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study of Subcutaneous and Intravenous Administration of IL-31 mAb (anti-Interleukin 31 Monoclonal Antibody; BMS-981164) in Healthy Subjects and Adult Subjects with Atopic Dermatitis

• IRAS ID

  106110

• Contact name

  Peter Dewland

• Sponsor organisation

  Zymogenetics (Bristol-Myers Squibb company)

• Eudract number

  2012-001865-34

• Clinicaltrials.gov Identifier

  01614756

• Research summary

  This study is an evaluation of the safety, tolerability, pharmacokinetics and pharmacodynamics as well as immunogenicity of a new drug - BMS-981164 in healthy subjects and patients with Atopic Dermatitis. The investigational study drug BMS-981164 is being developed by the sponsor, Bristol-Myers Squibb Research and Development as an intended treatment for an inflammatory skin condition called Atopic Dermatitis. This study will be the first time BMS-981164 is administered to humans. The aim of the study is to assess the effects of a subcutanous (under skin) injection or intravenous formulation of BMs-981164 in 2 parts. Part 1 will assess the safety, tolerability and blood levels of ascending single doses of BMS-981164 in healthy volunteers. In Part 2, safety, tolerability and blood levels of BMS-981164 will be assessed in patients with the condition called Atopic Dermatitis. PART 1: It is planned that 6 groups of 8 subjects will be enrolled. In each group 6 subjects will receive a single dose of BMS-981164 and 2 will receive placebo (dummy drug). The order in which volunteers will be allocated to treatment is random. The dose may be increased in each cohort. Initial doses will be delivered as subcutanous injections and higher doses will be delivered intravenously. Two additional cohorts of 8 volunteers each, can be introduced for cohort expansion, intermediate dose cohort evaluation and/or further safety evaluation as recommended by the Safety Monitoring Committee. PART 2: Up to 4 groups of 8 patients with moderate to severe atopic dermititis may be enrolled. In each group 6 volunteers will receive dose of BMS-981164 and 2 will receive placebo. Treatment allocation is random. The dose might be increased in each cohort. Subjects are expected to attend a screening visit, treatment period and follow up visit on each part of the study.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  12/NW/0386

• Date of REC Opinion

  18 Jun 2012

• REC opinion

  Further Information Favourable Opinion