Highlights
- Using specifically targeted biomarkers, CHDR can demonstrate the pharmacological effects of biopharmaceuticals early in clinical drug development, even in healthy subjects.
- The outcome of first-in-human studies provides a stronger basis for establishing dosage and safety profiles in future studies involving patients.
- We have extensive experience addressing species specificity, immunogenicity, and unpredicted side effects, as well as establishing the starting dose, thereby optimising safety.
Experience with a wide range of products
Biotherapeutics include a highly diverse array of biologically active compounds. Some of these compounds are produced in animals, bacteria, or cultured cells, whereas others (such as nucleotides) are synthesised chemically. CHDR has a long history of studying biologicals, including antibodies, lipoproteins, RNA, and DNA, and many of these compounds were first administered to human subjects at CHDR.
For example, CHDR performed the first-in-human studies of the promising new drug ApoA-1 Milano, a biologically produced apolipoprotein used to treat atherosclerosis. These studies helped establish a safe dose for use in human subjects. We subsequently studied ApoA-1 Milano in patients with stable coronary artery disease.
Practical answers to important research questions
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What happens to our compound after it’s administered?
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Are the compound’s unintentional side effects due to impurities, or are they inherent to the compound’s mechanism of action?
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Is our biosimilar equivalent to – or even better than – the original patented drug?
