Trial Profile
A Study to Evaluate the Bioequivalence of Tocilizumab Following Subcutaneous Administration Via an Autoinjector (AI 1000-G2) Versus a Pre-Filled Syringe in Healthy Volunteers
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 09 Dec 2018
Price :
$35
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At a glance
- Drugs Tocilizumab (Primary)
- Indications Amyotrophic lateral sclerosis; Chronic lymphocytic leukaemia; Dermatomyositis; Drug hypersensitivity; Giant cell arteritis; Giant lymph node hyperplasia; Juvenile rheumatoid arthritis; Osteoarthritis; Polymyalgia rheumatica; Polymyositis; Rheumatoid arthritis; Schnitzler syndrome; Systemic scleroderma; Vasculitis
- Focus Pharmacokinetics; Registrational
- Sponsors Roche
Most Recent Events
- 26 Nov 2018 According to a Genentech media release, the U.S. FDA has approved ACTPen 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra as an additional formulation for adult patients with moderate to severe active rheumatoid arthritis, giant cell arteritis and two forms of juvenile arthritis (PJIA and SJIA).This approval of the ACTPen is based on clinical data from this phase I bioequivalence study (NCT02678988) and phase IV human factors study (NCT02682823), presented at the ASCPT-2018.
- 24 Mar 2018 Primary endpoint (Area under the serum concentration-time curve from time zero to last quantifiable concentration (AUClast) of TCZ) has been met presented at the 119th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
- 24 Mar 2018 Primary endpoint (Maximum observed serum concentration (Cmax) of TCZ) has been met as per the results presented at the 119th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.