Early Clinical Development

First-in-human studies and proof-of-concept trials to accelerate drug development

Phase I Excellence

Oracle BioTech specializes in early clinical development, providing comprehensive first-in-human studies, dose escalation trials, and proof-of-concept studies with the highest safety standards.

First-in-Human Studies

First-in-Human Studies

Specialized Phase I units and expert medical teams ensuring safe and efficient first-in-human dose escalation studies.

  • Dose escalation design
  • Safety monitoring
  • Pharmacokinetic studies
  • Biomarker assessment
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Proof of Concept

Proof-of-Concept Trials

Innovative Phase IIa studies demonstrating early efficacy signals and optimal dose selection for further development.

  • Biomarker-driven designs
  • Adaptive trial methodologies
  • Patient stratification
  • Go/no-go decision support
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Early Development Process

IND Filing

Regulatory

Investigational new drug application preparation.

Phase I

Safety

First-in-human safety and dose escalation.

Phase IIa

Proof

Proof-of-concept and optimal dose selection.

Decision

Go/No-Go

Development decision based on early data.

Transition

Phase IIb

Preparation for late-stage development.