Dose Escalation Studies
To determine the safety and optimal dosing of investigational therapies, early-phase clinical trials rely heavily on dose escalation studies. The Accelsiors Phase I unit takes this backbone of early phase studies very seriously, as we specialise in executing single ascending dose (SAD) and multiple ascending dose (MAD) studies. We do so by combining our proprietary methodologies, robust safety monitoring, and our very own expert analysis to provide decision making data that guides your clinical programme.
Key Features of Our Dose Escalation Studies
Designing and executing single ascending dose (SAD) and multiple ascending dose (MAD) studies is our expertise at Accesliors. Our experience in this helps align with your therapeutic goals. Beyond our expertise, our adaptive dose escalation models make it easy to respond to emerging data, allowing us to safely and efficiently progress with dosing. Combining a dynamic safety framework with real-time data, we maximise trial efficiency and minimise exposure to suboptimal or high-risk doses. It is exactly that proactive planning and streamlined process that enable us to deliver results in a timely manner, as we accelerate your programme.
Accelsiors dose escalation trials are ensured by our advanced safety decision framework, which includes real-time monitoring, expert consultations, and rigorous dose-limiting toxicity (DLT) checks. These processes guarantee safety thresholds are always carefully monitored, stopping escalation at the appropriate dose level to protect study participants. Precise cohort management, continuous safety assessments and trend assessments to adjust our strategy is carefully conducted and tracked by our experienced clinical team. This way we ensure trial continuity and participant safety.
By integrating pharmacokinetic (PK) and pharmacodynamic (PD) assessments in our dose escalation studies, we provide decision making data into dose-response and therapeutic windows. These assessments, combined with DLT evaluations and emerging safety data, ensure smooth transitions to defining the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D). Detailed analysis and datasets ensure assured decision-making and regulatory compliance.
At Accelsiors Phase I Unit we pride ourselves with our wide network of specialists, who are here to address therapeutic-specific challenges. This expertise, which includes immunology, cardiovascular, metabolic, and many others, ensures a thorough evaluation at every dose level. After each cohort, we deliver detailed reports in line with regulatory requirements, including safety data, PK/PD analysis, and DLT evaluations. Our detailed and high-quality Accelsiors reports enable seamless regulatory submissions, future trial planning, as well as smooth progression into later phases.
