OLP-1002 is Being Studied in the Treatment of Pain.

• Status: Completed
• Trial end date: 2020-10-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: OliPass Corporation

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 < 3.0 or > 9.0.