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news.Sosei Group, a Japanese biopharmaceutical company, has announced the successful results of two Phase I trials for its collaborative project on SD118, a compound in development for the treatment of neuropathic pain.
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The Phase I trials were both double-blind, placebo-controlled, dose escalation studies designed to evaluate the safety, tolerability and pharmacokinetics of SD118 administered in an oral formulation.
In the first trial, a single ascending dose study conducted in 56 healthy male volunteers, no serious adverse events (SAEs) were reported in any of dose ranges including the highest dose used in the study. Notably, the plasma concentration of SD118 increased proportionately with administered doses of the drug across the entire dose range investigated. Consequently, SD118 was considered to be safe and well tolerated in doses up to 2000mg, the company said.
In the second trial, a multiple ascending dose study conducted in 36 healthy male volunteers, no SAEs were reported and SD118 was considered safe and well tolerated. In this study the pharmacokinetic profile also showed a plasma concentration increase in proportion to doses of SD118 from 100mg BID to 2,000mg BID.
Shinichi Tamura, president and CEO of Sosei, said: I am delighted that SD118 demonstrated a good safety profile, especially considering the wide range of doses tested. This project is now ready to move into the next step of development.