Navigating Challenges in a Single-Dose Study to Evaluate Pharmacokinetic and Immunogenicity Endpoints of a Recombinant Humanized mAb

Navigating Challenges in a Single-Dose Study of a Recombinant Humanized mAb to Evaluate Pharmacokinetic and Immunogenicity Endpoints.

Study Overview:

Conducting clinical studies for monoclonal antibodies (MABs) involves meticulous planning and execution, especially for recombinant humanized mAbs administered via intravenous (i.v.) infusion. This Recombinant humanized mAb targets subdomain II of the human epidermal growth factor receptor 2 protein (HER2), and it is indicated for use in Metastatic Breast Cancer (MBC) and Early Breast Cancer (EBC) in combination with other mAbs or chemotherapy agents

This blog focuses on a single-dose study to evaluate pharmacokinetic (PK) and immunogenicity endpoints of a recombinant humanized mAb which was administered via intravenous (i.v) infusion to Healthy subjects.

Study Design:

  • Double-Blind, Single Dose, Parallel Study
  • Blood Sample Collections for PK & Immunogenicity Assessment

Selection & Safety Parameters for Study Subjects:

  • Screening Process:
    • The screening of study subjects included clinical examinations, ECG, chest X-ray, echocardiogram, TMT, and various laboratory tests, including cardiac markers.
  • Observation and Monitoring
    • Subjects were housed under the observation of intensivists / MD medicine specialists / Cardiologists to ensure their safety.
    • Continuous cardiac monitoring during the IMP administration via intravenous infusion.
    • All lifesaving drugs were readily available in the form of an emergency tray in the ward area, ensuring immediate response to any adverse events.

Key Challenges and Considerations

Discover how we tackled and conquered various challenges in our study, implementing effective solutions for a successful outcome.

Conducting a single-dose study with pharmacokinetic and immunogenicity endpoints for a Recombinant Humanized mAb involved several critical considerations. From stringent subject selection to meticulous planning of IMP administration and continuous safety monitoring, each step was vital for the success of the study.

Extensive Experience

Our highly specialized team, composed of global experts in early development and clinical pharmacology, meticulously designs an integrated early-phase program. We possess extensive experience in conducting a variety of studies, ranging from first-in-human to drug-drug interaction, enabling informed decisions. This includes first-in-human (FIH), proof-of-concept, bioavailability/bioequivalence (BA/BE), drug-drug interaction (DDI), biosimilar, and various pharmacokinetic (PK), single ascending dose/multiple ascending dose (SAD/MAD) studies. Leveraging our advanced facilities, operational expertise, and wealth of clinical development experience, we ensure the precise execution of your clinical trials involving patients and/or healthy volunteers.

Connect with our experts at [email protected] to leverage the extensive end-to-end capabilities of Lambda Therapeutic Research & Novum Pharmaceutical Research Services having global footprint across India, USA and Canada.