A double-blind, placebo-controlled, dose escalation study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of KCP506 in healthy subjects
- Conditions
- Chronic painchronic pain
- Registration Number
- NL-OMON55203
- Lead Sponsor
- Kineta Chronic Pain, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 108
Gender: male (all parts) or female (Parts A and B only)
Age: 18 to 55 years, inclusive, at screening
Weight: 50 to 105 kg, inclusive
Body mass index: 18.0 to 30.0 kg/m2, inclusive
Status: healthy subjects
1. Previous participation in the current study.
2. Employee of PRA, CHDR or the Sponsor.
3. History of relevant drug and/or food allergies, per the Investigator*s
assessment.
4. Using tobacco products within 60 days prior to first drug administration
5. History of alcohol abuse or drug addiction (including cannabis products),
per the Investigator*s assessment.
6. Positive drug and/or alcohol screen (opiates, methadone, cocaine,
amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines,
tricyclic antidepressants, nicotine [cotinine - Parts A and B only]. and
alcohol) at screening or first admission to the clinical research center. Tests
may be repeated once at screening and once at admission in case of a suspected
false positive result.
7. Average intake of more than 24 units of alcohol per week (1 unit of alcohol
equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).
8. Positive screen for hepatitis B surface antigen (HBsAg), antihepatitis C
virus (HCV) antibodies, or antihuman immunodeficiency virus (HIV) 1 and 2
antibodies.
9. Participation in a drug study within 60 days (Parts A and B) or 90 days
(Part C) or 5 drug elimination half-lives, whichever is longer) prior to the
first drug administration in the current study. Participation in more than 3
other drug studies in the 10 months prior to the first drug administration in
the current study.
10. Donation or loss of more than 100 mL of blood within 60 days prior to the
first drug administration. Donation or loss of more than 1.5 liters of blood
(for male subjects)/more than 1.0 liters of blood (for female subjects) in the
10 months prior to the first drug administration in the current study.
11. Significant and/or acute illness within 5 days prior to the first drug
administration that may impact safety assessments or be consistent with
COVID-19 infection, in the opinion of the Investigator.
12. Unsuitable veins for infusion or blood sampling.
13. Close contact with persons diagnosed with COVID-19 within 14 days prior to
screening.
14. Positive nasopharyngeal PCR test for SARS-CoV-2 on Day -1.
15. Receipt of a vaccine within 14 days prior to the first study drug
administration (Parts A and B) or either study drug administration (Part C).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• To evaluate the safety and tolerability of KCP506 in healthy adults,<br /><br>following a single intravenous (iv) or subcutaneous (sc) injection at<br /><br>escalating dose levels<br /><br>• To evaluate the safety and tolerability of KCP506 in healthy adults,<br /><br>following multiple iv or sc injections at escalating dose levels</p><br>
- Secondary Outcome Measures
Name Time Method <p>• To evaluate the PK of KCP506 in healthy subjects, following a single iv or sc<br /><br>injection at escalating dose levels<br /><br>• To evaluate the PK of KCP506 in healthy subjects, following multiple iv or sc<br /><br>injections at escalating dose levels</p><br>