Clinical trial NCT03760913: OLP-1002 is Being Studied in the Treatment of Pain.
Official title: OLP-1002 - A First-in-human, Double-blind, Placebo-controlled, Single and Multiple Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pain
Keywords: Pain
Pain Injection
Lead sponsor: OliPass Corporation
Sponsor class: INDUSTRY
First posted: 2018-12-03
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a double-blind, randomized, placebo-controlled, single and multiple subcutaneous dose study.
Primary purpose: TREATMENT

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 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 \< 3.0 or \> 9.0.

Primary outcomes:
measure: Number of Participants With Adverse Events Stratified by Overall and Severity
timeFrame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
measure: Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure
timeFrame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
measure: Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate
timeFrame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
measure: Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate
timeFrame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
measure: 12-lead Electrocardiogram Parameters
timeFrame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
measure: Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results
timeFrame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
measure: Number of Participants With Full and Symptom-Directed Physical Examination Results
timeFrame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
measure: Number of Participants With Injection Site Assessment Results
timeFrame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
measure: Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies
timeFrame: Part A: Day 1 postdose. Part B: Day 1 postdose and Day 13 postdose.
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds CRU
Study officials:
affiliation: Covance CRU Leeds
name: Firas Almazedi, MBChB, MSc, CPI, DipPharmMed
role: PRINCIPAL_INVESTIGATOR
References: