Hearing Loss Clinical Trial
Official title:
Randomized, Placebo-controlled, Double-blind, Dose Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of HPN-07 and HPN-07 Plus NAC in Single Doses in Male and Female Subjects
This study is a single-center, randomized, placebo-controlled, double-blind, single
ascending dose escalation study to determine the safety, tolerability, and PK profile of
oral administration of HPN-07 in single doses to approximately 32 healthy male and female
subjects between 18 and 55 years of age.
Subjects will receive single oral doses of the study drug. The primary endpoint of this
trial is to establish the safety and tolerability of HPN-07 and HPN-07 plus N-acetylcysteine
(NAC).
This study is a single-center, randomized, placebo-controlled, double-blind, single
ascending dose escalation study to determine the safety, tolerability, and PK profile of
oral administration of HPN-07 in single doses to healthy male and female subjects between 18
and 55 years of age.
Approximately 32 subjects will be enrolled in a panel of 4 cohorts with approximately 8
subjects per cohort. There will be approximately 3 sequential ascending dosing levels of
HPN-07, with each cohort administered 1 dose of HPN-07 ranging from 500 mg to 1,500 mg and
the fourth cohort administered the highest tolerated dose of HPN-07 plus 1,200 mg NAC.
The primary endpoint of this trial is to establish the safety and tolerability of HPN-07 and
HPN-07 plus N-acetylcysteine (NAC). Pharmacokinetics (PK) analysis of HPN-07 will enable a
preliminary determination of the relationship between dose and the time course of the drug
concentration in the body. Blood samples will be collected at regular intervals over the
predicted time of HPN-07 systemic exposure.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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