Insights into first-in-human study design of oligonucleotides, Upcoming Webinar Hosted by Xtalks

In this free webinar, gain insight into the translational considerations related to the pharmacokinetics, pharmacodynamics and toxicity of oligonucleotide (ON) drugs. Attendees will learn key aspects of first-in-human study design, including assessments, study population, safety mitigation strategies (e.g., sentinel dosing, dose escalation and follow-up periods) and the evaluation of immunogenicity and QT-prolongation.

TORONTO, May 5, 2026 /PRNewswire/ -- The development of oligonucleotide (ON) drugs such as antisense ONs and siRNAs has accelerated rapidly and is highly sought after, with increasing diversity in modalities and applications. The use of ONs has expanded from treating rare diseases to addressing more prevalent conditions, enabled by advances in chemistry and conjugation technologies that improve tissue targeting and reduce safety risks. While the long-lasting effects of ONs offer major benefits in medical practice, rapid patient access is hampered by the lengthy first-in-human (FIH) trials needed to establish sufficient safety before demonstrating initial pharmacodynamic and early clinical effects.

While FIH experience with ONs has demonstrated favorable safety to date, the growing structural complexity of these molecules presents aspects that require closer consideration. This webinar will explore translational and clinical considerations for initiating FIH oligonucleotide studies, drawing on current literature and ICON's experience. The objective is to provide early drug developers and the broader scientific community with practical guidance and insights to support the successful advancement of this promising drug class.

During this webinar ICON will discuss:

• Translational considerations related to the pharmacokinetics, pharmacodynamics and toxicity of ON drugs
• Key aspects of first-in human study design, including assessments, study population, safety mitigation strategies (e.g., sentinel dosing, dose escalation and follow up periods) and the evaluation of immunogenicity and QT-prolongation

Register for this webinar to learn how oligonucleotides can be advanced through informed first-in-human study design.

Join experts from ICON, Rüdiger Kaspera, PhD, Clinical Pharmacologist, Drug Development Solutions; Kamelia Mirdamadi, PhD, Clinical Pharmacologist, Drug Development Solutions; and Thijs van Iersel, MD, Clinical Pharmacologist, Drug Development Solutions, for the live webinar on Wednesday, May 27, 2026, at 10am EDT (4pm CEST/EU-Central).

For more information, or to register for this event, visit Insights into first-in-human study design of oligonucleotides.

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Contact:
Vera Kovacevic
Tel: +1 (416) 977-6555 x371
Email: [email protected]

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