Episode Details

In this QCast episode, join co-hosts Jullia and Tom as they break down Phase 1 clinical trial designs. You’ll learn exactly what happens in single and multiple ascending-dose stages, discover modern dose-escalation methods, and find out how food-effect, interaction and bioequivalence studies fit in. They’ll also share practical strategies for combining objectives, using adaptive protocols and cutting timelines without sacrificing data quality. 

Key Takeaways

• Phase 1 is more than a basic safety check: it establishes pharmacokinetic and tolerability benchmarks that guide every later trial.
• Single ascending-dose studies map how a single dose behaves in the body, while multiple ascending-dose work reveals accumulation and longer-term durability.
• Adaptive escalation designs such as BOIN use real-time probability updates to find the right dose faster and with fewer volunteers.
• Early food-effect and drug to drug interaction trials determine prescribing instructions and label warnings before larger studies begin.
• Integrated protocols such as combining dose stages, meal-effect parts and interaction checks with interim review gates save time, reduce costs, and preserve trial flexibility.

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📝 Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
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About Quanticate

Founded in 1994, Quanticate is a biometrics-focused CRO with over 30 years' experience delivering expert clinical and post-marketing data services worldwide. Specialising in the collection, management, standardisation, analysis, and reporting of data, we support pharma and biotech companies globally with high-quality solutions for clinical development. We specialise in:

• Clinical Data Capture & Management
• Biostatistics & Statistical Consultancy
• Statistical Programming & PK/PD Analysis
• Medical Writing & Pharmacovigilance
• Regulatory & Submission Support
• AI & Automation
• Post-Marketing Safety & Real-World Data

Quanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.