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news.Otologic Pharmaceutics (OPI) has initiated a Phase I clinical trial of its lead product candidate HNPN-1010 to treat acute sensorineural hearing loss.
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NHPN-1010 is being developed to treat noise-induced hearing loss (NIHL) and Cisplatin-induced hearing loss (CIHL).
The Phase I trial will determine the safety, tolerability and pharmacokinetic (PK) profile of oral administration of HPN-07 alone and in combination with N-acetylcysteine (NAC) in single doses in healthy male and female subjects between 18 and 55 years of age.
OPI CEO Clayton Duncan said: "Initiation of clinical testing on NHPN 1010 is a major development milestone for OPI.
"We have completed the dosing of the first of four cohorts of patients, and based on this progress, we anticipate top-line data in Q1 of 2015. This puts OPI on track to initiate Phase 2 clinical trials in NIHL or CIHL in 2015."
A total of 32 subjects will be enrolled in four groups of the single-centre, randomized, placebo-controlled, double-blind, single ascending dose escalation trial.
During the trial, the first three groups will receive sequential ascending dosing levels of HPN-07 from between 500mg and 1,500mg, with the fourth cohort receiving the highest tolerated dose of HPN-07 plus 1,200mg NAC (NPHN-1010).