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
Phase of Trial: Phase I
Latest Information Update: 30 Mar 2017
At a glance
- Drugs Itolizumab (Primary) ; Itolizumab (Primary)
- Indications Multiple sclerosis; Psoriasis; Rheumatoid arthritis
- Focus Adverse reactions; Pharmacokinetics
- Sponsors Biocon
- 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.
- 05 Jul 2016 New trial record