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A Randomized, Double Blind, Placebo Controlled, Single Ascending Dose, Phase I Study of Itolizumab (Bmab 600) Administered Subcutaneously and a Randomized, Partial Blind, Placebo-controlled, Comparative Pharmacokinetic and Safety Study of Two Formulations of Itolizumab Administered Intravenously and a Bioavailability Assessment of Subcutaneous Administration of Itolizumab (Bmab 600) in Normal Healthy Subjects

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Trial Profile

A Randomized, Double Blind, Placebo Controlled, Single Ascending Dose, Phase I Study of Itolizumab (Bmab 600) Administered Subcutaneously and a Randomized, Partial Blind, Placebo-controlled, Comparative Pharmacokinetic and Safety Study of Two Formulations of Itolizumab Administered Intravenously and a Bioavailability Assessment of Subcutaneous Administration of Itolizumab (Bmab 600) in Normal Healthy Subjects

Status: Suspended
Phase of Trial: Phase I

Latest Information Update: 16 Jul 2019

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At a glance

  • Drugs Itolizumab (Primary) ; Itolizumab (Primary)
  • Indications Multiple sclerosis; Psoriasis; Rheumatoid arthritis
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Biocon

Most Recent Events

  • 18 Dec 2017 Status changed from recruiting to suspended.
  • 29 Mar 2017 An additional PK sample collection on Day 75 has been included and A parallel placebo group of IV infusion has been added as a comparator in Stage 2 hence patient number also increases. Study title also amended.
  • 29 Mar 2017 Planned number of patients changed from 68 to 74.

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