A Phase 2 Study To Assess The Efficacy, Tolerability, And Safety OF NKTR-181 In Subjects With Chronic OA Knee Pain
A Phase 2 Study To Assess The Efficacy, Tolerability, And Safety OF NKTR-181 In Subjects With Chronic OA Knee Pain
NKTR-181 is being developed as an analgesic compound for the treatment of moderate to severe
 chronic pain - active as a mu agonist, but with inherent molecular properties designed to
 provide a unique clinical profile, including most notably, reduced CNS side effects and an
 attenuated attractiveness as a target of abuse.
Inclusion Criteria:

 -  Willing and able to give written informed consent;

 -  Willing and able to understand the study procedures, and comply with all study
 procedures;

 -  Females or males, age ≥ 18 years old;

 -  Body mass index 18-39, inclusive;

 -  In good general health;

 -  Clinical diagnosis of OA in one or both knees;

 -  Have been on a stable regimen of pain medication for the management of OA knee pain;

 -  Not experiencing adequate pain relief with their current dosing regimen;

 -  Women of childbearing potential (WCBP) must agree to use highly effective methods of
 birth control. Male subjects must agree to use contraception.

 Exclusion Criteria:

 -  Females who are pregnant or lactating;

 -  Known history of hypersensitivity, intolerance, or allergy to opioids;

 -  Diagnosed as having any chronic pain symptom that in the Investigator's opinion would
 interfere with the assessment of pain and other symptoms of OA;

 -  Presence of any medical condition that would preclude study participation in the
 opinion of the investigator;

 -  Clinically significant abnormalities of vital signs or clinical laboratory results;

 -  Clinically significant electrocardiographic abnormalities;

 -  Received systemic corticosteroids within 30 days prior to signing the consent form;

 -  Subjects who are known or suspected to be currently abusing alcohol or drugs;

 -  Positive urine drug screen, or alcohol breath test during Screening Period testing;

 -  Positive serology for the surface antigen of Hepatitis B (HBsAg) or Hepatitis C
 (anti-HCV) during Screening Period testing;

 -  Known to be human immunodeficiency virus (HIV) positive;

 -  Donation of blood or plasma within 30 days prior to signing the consent form;

 -  Participation in another drug or biologic study within 30 days prior to signing the
 consent form;

 -  Any other reason that, in the opinion of the Investigator or Medical Monitor, would
 render the subject unsuitable for participation in the study.