Status:
COMPLETED
OLP-1002 is Being Studied in the Treatment of Pain.
Lead Sponsor:
OliPass Corporation
Conditions:
Pain
Eligibility:
All Genders
18-60 years
Phase:
EARLY_PHASE1
Brief 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.
Detailed Description
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 th...
Eligibility Criteria
Inclusion
- 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
- 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 \< 3.0 or \> 9.0.
Key Trial Info
Start Date :
November 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2020
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT03760913
Start Date
November 21 2018
End Date
October 16 2020
Last Update
August 26 2021
Active Locations (1)
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1
Leeds CRU
Leeds, United Kingdom, LS2 9LH