First-in-Human – resources

HumanADMEOur Enabled-First-in-Human® (Enabled-FIH) programs integrate real-time drug product manufacturing with healthy volunteer and patient clinical testing into a seamless early development plan. With a wealth of experience and state-of-the-art manufacturing and clinical facilities on site, our team will work closely with you to:

  • reduce time to Proof-of-Concept;
  • minimize up-front investment;
  • and simplify supply chains.

Enabled-FIH programs are applicable to all molecules (small and large), all formulation types (from simple to complex) and all routes of dose administration.

Learn more

Explore our selection of case studies, fact sheets and scientific posters and see how we can help you to save valuable drug development time and reduce investment costs.

 

Fact sheet

Enabled-First-in-Human Fact Sheet

 

 

Scientific posters

New

AACR 2016 - Clinical Pharmacokinetics and Pharmacodynamics of ME-401, an Oral, Potent and Selective Inhibitor of Phosphatidylinositol 3-Kinase P110δ, Following Single Ascending Dose Administration to Healthy Volunteers ASCPT 2016 - A randomised double-blind dose escalation study to evaluate the safety and dose response of subcutaneous administration of coversin in healthy subjects

 

Seminar presentation

ASCPT 2016 - Accelerating Timelines from Candidate Selection to Proof-of-Concept with Enabled-FIH® programs

 

Archive

AAPS 2015 - Assessment of safety, tolerability, pharmacokinetics, proof of concept and proof of pharmacological effect of orally administered CORT125134 using an adaptive clinical protocol AAPS 2015 - Rapid evaluation of a novel small molecule c-Met tyrosine kinase inhibitor in healthy subjects Two approaches for determining absolute bioavailability and intravenous pharmacokinetics in first-in-human studies for oral drug products Assessment of the safety, tolerability and pharmacokinetics of single doses of oral dexanabinol in healthy subjects, using an adaptive protocol A First-in-Human (FIH) Study of BCX4161, an Oral Kallikrein Inhibitor, using a Translational Pharmaceutics Platform ASCPT 2014 Design of multi-part protocol to assess the tolerability and pharmacodynamic effects of PUR118 in healthy subjects and COPD patients

 

Re-engineering the early development process for pulmonary drug-delivery products

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