olp-1002 is being studied in the treatment of pain.

Conditions: Pain

Summary: the primary objective of the study is to assess the safety and tolerability of single and multiple subcutaneous doses of olp-1002 in healthy subjects.

the exploratory objectives of the study are to evaluate the pharmacodynamic effect of olp-1002 following single subcutaneous doses in healthy volunteers using a capsaicin pain model, and to monitor the effects of a single subcutaneous doses of olp-1002 on cardiac qt interval. where possible, single and/or multiple subcutaneous dose pharmacokinetics of olp-1002 in healthy subjects will be determined.

Eligibility criteria:
inclusion criteria: * healthy male or females of any race, between 18 and 60 years of age, inclusive. * body mass index between 18.0 and 28.0 kg/m², inclusive. * in good health, determined by no clinically significant findings from medical history, physical examination, single 12-lead electrocardiogram (resting heart rate \> 45 bpm and \< 90 bpm), vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[eg, suspicion of gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at screening as assessed by the investigator (or designee). * willing to abide by the contraception requirements. * able to comprehend and willing to sign an informed consent form and to abide by the study restrictions. exclusion criteria: * significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee). * history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee). * any of the following: * qt interval corrected for heart rate using fridericia's method \> 450 ms confirmed by repeat measurement. * qrs duration \> 110 ms confirmed by repeat measurement. * pr interval \> 220 ms confirmed by repeat measurement. * findings which would make qt interval corrected for heart rate measurements difficult or qt interval corrected for heart rate data uninterpretable. * history of additional risk factors for torsades de pointes (eg, heart failure, hypokalemia, family history of long qt syndrome). * female subjects who are pregnant or breastfeeding. * history of alcoholism or drug/chemical abuse within 1 year prior to screening. * alcohol consumption of \> 21 units per week for males and \>14 units per week for females. one unit of alcohol equals ½ pint (285 ml) of beer or lager, 1 glass (125 ml) of wine, or 1/6 gill (25 ml) of spirits. * positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at screening or check-in. * positive hepatitis panel and/or positive human immunodeficiency virus test. * active skin conditions such as dermatitis, allergy, eczema, psoriasis, or abnormal healing. * tattoos, scars, or moles that in the opinion of the investigator are likely to interfere with dosing or study assessments at any of the potential injection sites. * participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days or 5 half-lives of the investigational product, whichever is longer, prior to check-in. * use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including st. john's wort, within 30 days prior to check-in, unless deemed acceptable by the investigator (or designee). * use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptive concomitant medications within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee). * use or intend to use slow-release medications/products considered to still be active within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee). * use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to check-in, unless deemed acceptable by the investigator (or designee) and/or sponsor have given their prior consent. * use of tobacco- or nicotine-containing products within 3 months prior to check-in. * receipt of blood products within 60 days prior to check-in. * donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening. * poor peripheral venous access. * have previously completed or withdrawn from this study or any other study investigating olp-1002, and have previously received the investigational product. * subjects who, in the opinion of the investigator (or designee), should not participate in this study. * part a - pd assessment groups only * subjects considered non-acceptable responders to the intradermal capsaicin test at screening, defined as maximum vas score of \ 9.0.

Keywords: pain pain injection