Study to Investigate the Safety of LT5001 Drug Product for Uremic Pruritus in Hemodialysis Patients

Exclusion Criteria

• •1. History of alcohol abuse, illicit drug use, physical dependence to any opioid or narcotic, or any history of drug abuse or addiction within 6 months of screening.
• •2. History of major surgery or trauma within 12 weeks of screening in the judgement of the investigator, or surgery planned during the study.
• •3. Has received ultraviolet B treatment, opioid antagonists (eg, naloxone, naltrexone), or opioid mixed agonist-antagonist (eg, nalbuphine) within 30 days prior to the Screening Visit or anticipated to receive such treatment during the study.
• •4. Has had a significant alteration in dialysis regimen within 2 weeks of the Screening Visit or anticipated to be receiving nocturnal dialysis, home hemodialysis treatment, or kidney transplant during the study.
• •5. Has any known history of allergic reaction to opioids.
• •6. History of latest positive serology test for HBV (HBsAg) or HCV (anti-HCV) within 1 year prior randomization consistent with current infection. Confirmatory tests will be allowed at the discretion of the investigator to rule out false positives.
• •7. Has any known history of HIV.
• •8. Positive pregnancy test or is lactating.
• •9. Has required peritoneal dialysis.
• •10. Alanine aminotransferase and/or aspartate aminotransferase concentration \> 2 x the ULN, or total bilirubin \> 1.8 x ULN, or hemoglobin concentration \< 9 g/dL at the Screening Visit.
• •11. Has taken other investigational drugs or participated in any clinical study within 30 days or 5 half-lives (if known) of the investigational drug's PK, PD, or biological activity (if known), whichever is longer, prior to first dose of study drug in this study or is currently participating in another clinical study.
• •12. Has received a vaccination within 3 days prior to administration of the first dose of study drug.
• •13. Has pruritus probably or definitely attributed to a cause other than renal disease or its complications such as atopic dermatitis, chronic urticarial, or hepatic pruritus caused by chronic liver disease.
• •14. Presence of skin infection (as defined by the investigator) on the area to be treated.
• •15. Any other condition or prior therapy that, in the investigator's opinion, would make the patient unsuitable for the study, or unable or unwilling to comply with the study procedures
• •16. Involved in the planning or conduct of this study.
• •17. Unwilling or unlikely to comply with the requirements of the study.