The Effect of Injection Site Cooling on Pain Experienced After the Administration of CNTX-4975-05 Into the Knee
The Effect of Injection Site Cooling on Pain Experienced After the Administration of CNTX-4975-05 Into the Knee
A clinical study to measure the effects of injection-site cooling on pain experienced after
 knee injections of capsaicin in healthy subjects and in patients with knee osteoarthritis.
Cohort 1 Key Inclusion Criteria:

 -  Subject is aged between 18 and 45 years, inclusive.

 -  Subjects Body Mass Index (BMI) is between 18 and 32 kg/m^2, inclusive and subject's
 weight is greater than or equal to 50 kg.

 -  Subjects must be in good health, in the opinion of the Investigator, as determined by
 a medical history, physical examination, clinical laboratory tests, vital signs and 12
 lead electrocardiogram (ECG).

 Cohort 1 Key Exclusion Criteria:

 -  Subject has had a clinically significant illness that has not completely resolved in
 the four weeks before screening.

 -  Subject has a history of neurological disorder which may impact the perception of pain
 or impairs the subject's ability to fully participate in the trial.

 Cohorts 2-4 Key Inclusion Criteria:

 -  Subject is aged between 45 and 75 years, inclusive.

 -  Subject's BMI is between 18 and 32 kg/m^2, inclusive and subject's weight is greater
 than or equal to 50 kg.

 -  Subject has a diagnosis of bilateral moderate to severe painful knee OA (subjects will
 be required to have a score on Pain with walking in the previous 24 hours, of 4 to 9,
 inclusive NPRS 0-10). The condition must be chronic with a history of painful
 arthritis for at least 3 months prior to entry in the study.

 Cohorts 2-4 Key Exclusion Criteria:

 -  Subject has had a clinically significant illness, other than osteoarthritis, that has
 not completely resolved in the four weeks before screening.

 -  Subject has a history of neurological disorder which may impact the perception of pain
 or impairs the subject's ability to fully participate in the trial.

 -  Subject has used analgesic medications in the 2 days prior to dosing, except for
 paracetamol, as needed.

 -  Subject has used topical medications applied to the knee for OA pain (including
 capsaicin, lidocaine, prescription or OTC medications) from 90 days prior to screening
 through to dosing.

 -  Subject has been injected with corticosteroids in the knee 90 days prior to screening
 through to dosing.

 -  Subject currently uses opioids for any condition other than OA knee pain (maximum dose
 15 mg hydrocodone, or equivalent, per day prescribed by a physician).