pain and itching distressing and stinging pain Neuropathic pain nociceptive pain numbness pain - burning
Conditions
Interventions
Sponsors
QPS Netherlands B.V.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Subjects have signed the informed consent form prior to any study related activity. 2. Subjects are healthy male volunteers between 18 and 55 years of age at the screening (inclusive). 3. Subject has a BMI * 18.0 kg/m and * 30.0 kg/m2 at the screening. 4. Subject can stay in the study center for 3 nights. 5. Subject is appropriate for the study in the judgement of the investigator, based on physical examination, laboratory tests, and subject*s interview. 6. Subject has a high probability for compliance with and completion of the study. 7. Male subjects must agree to either abstain from sexual intercourse or use a condom with spermicide during the duration of the study until 90 days after their last dose in the study. 8. Subjects are non-smoker for at least 6 months. 9. Subject must have skin type 1 or 2 according to Fitzpatrick Skin Typing Test. (not applicable for cohort 1).
Exclusion criteria
Exclusion criteria: 1. Subject shows clinically significant abnormalities in physical examination or vital signs, according to the investigator*s judgement. 2. Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases. 3. Has a history of significant and/or severe allergies. 4. Had major surgery, donated or lost 1 unit of blood or plasma (approximately 500 mL) within 4 weeks prior to the pretrial (screening) visit. 5. Has participated in another investigational trial within 90 days prior to the first intake of the IMP of this study. 6. Subject has an abnormal laboratory result judged by the investigator as being clinically significant. 7. Subject has used any prescription drug or herbal medicine within 14 days, OTC or vitamin supplements within 7 days prior to Day 1. 8. Subject has tattoos on the skin areas to be exposed with UV radiation (not for cohort 1). 9. Standard liver function tests including ALT, AST, alkaline phosphatase, gamma-glutamyl transferase, lactate dehydrogenase and bilirubin (total and direct) do not exceed the upper limit of normal for the local laboratory during screening and day -1. 10. Subject has a positive urinary drug screen (incl. amphetamine, barbiturates, benzodiazepines, cocaine, marijuana, methadone, methamphetamine, morphine, phencyclidine, and tricyclic antidepressants). 11. History of abuse of alcohol or drugs in the last 2 years (alcohol >23 units/week). 12. Subject has a positive test for HIV antibody, HBsAg, or HCV antibody. 13. Subject has a QTc (Bazet) prolongation greater than or equal to 450 ms. 14. Subject has ECG with one or more of the following criteria (a single repeat is allowed for eligibility determination, at screening and day -1): Pulse rate 100 bpm PR Interval 200 msec QRS duration 120 msec 15. Subject is unwilling or unable to adhere to any specific protocol restriction as mentioned in Section 8.3.3 of this protocol. 16. Male subject who plans to father a child during the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To asses safety and tolerability of four different single doses of Neu-P12. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the pharmacokinetics, pharmacodynamics, safety, and tolerability of different single doses of Neu-P12. | — |
Countries
The Netherlands
Outcome results
None listed