Chronic pain chronic pain
Conditions
Interventions
Part A:
Group Study compound Dose* Route of administration
1 KCP506 or placebo 1.0 mg/kg In a vein
2 KCP506 or placebo 3.0 mg/kg In a vein
3 KCP506 or placebo 10 mg/kg In a vein
4 KCP506 or placebo 30
Sponsors
Kineta Chronic Pain, LLC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • To evaluate the safety and tolerability of KCP506 in healthy adults, following a single intravenous (iv) or subcutaneous (sc) injection at escalating dose levels • To evaluate the safety and tolerability of KCP506 in healthy adults, following multiple iv or sc injections at escalating dose levels | — |
Secondary
| Measure | Time frame |
|---|---|
| • To evaluate the PK of KCP506 in healthy subjects, following a single iv or sc injection at escalating dose levels • To evaluate the PK of KCP506 in healthy subjects, following multiple iv or sc injections at escalating dose levels | — |
Countries
Netherlands
Outcome results
None listed