Blinding Approaches for Large Clinical Trials Involving Sub-Cutaneous Administration of Biologicals - A CMC Perspective.

Abstract

A well-controlled clinical trial is one of the critical steps to evaluate the efficacy and safety of novel medicaments. The use of a placebo is employed in several types of clinical trials in order to set a baseline against which the efficacy of the investigational drug is evaluated. An ideal placebo should match the final formulation as close as possible such that the patient/health care providers are unable to identify any difference. This is difficult for high concentration biologic intended for subcutaneous administration, mainly because of their color and viscosity. Currently, the challenge is overcome by using opaque labels or by unblinded pharmacists, both solutions are expensive. The present study provides an efficient alternative where a protein excipient (recombinant albumin) is used to prepare a placebo for biologicals. We have demonstrated that the use of recombinant albumin can match the color of the active when used in the right quantity. The evaluated solution is highly flexible and has the potential to match the color of different biopharmaceuticals at different concentrations/formulations.