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

NCT ID: NCT03760913

Last Updated: 2021-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-21
• Study Completion Date: 2020-10-16

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

OLP-1002: Part A, Single Ascending Dose

Subcutaneous Injection: 30 ng, 120 ng, 400 ng, 1.2 μg, 3 μg, 6 μg, 12 μg, 20 μg, 40 μg, 80 μg, 160 μg

Group Type: EXPERIMENTAL

OLP-1002 (Test): Part A, Single Ascending Dose

Intervention Type: DRUG

Subcutaneous Injection: 30 ng, 120 ng, 400 ng, 1.2 µg, 3 µg, 6 µg, 12 µg, 20 µg, 40 μg, 80 μg, 160 μg

OLP-1002: Part B, Multiple Ascending Dose

Subcutaneous Injection: 5 x 2 μg, 5 x 5 μg, 5 x 10 μg, 5 x 20 μg, 5 x 40 μg, 5 x 80 μg

Group Type: EXPERIMENTAL

OLP-1002 (Test): Part B, Multiple Ascending Dose

Intervention Type: DRUG

Subcutaneous Injection: 5 x 2 μg, 5 x 5 μg, 5 x 10 μg, 5 x 20 μg, 5 x 40 μg, 5 x 80 μg

Placebo Part A, Single Ascending Dose

Subcutaneous Injection: Placebo

Group Type: PLACEBO_COMPARATOR

Placebo: Placebo Part A, Single Ascending Dose

Intervention Type: OTHER

Subcutaneous Injection: Placebo

Placebo Part B, Multiple Ascending Dose

Subcutaneous Injection: Placebo x 5

Group Type: PLACEBO_COMPARATOR

Placebo: Placebo Part B, Multiple Ascending Dose

Intervention Type: OTHER

Subcutaneous Injection: Placebo x 5

Interventions

OLP-1002 (Test): Part A, Single Ascending Dose

Subcutaneous Injection: 30 ng, 120 ng, 400 ng, 1.2 µg, 3 µg, 6 µg, 12 µg, 20 µg, 40 μg, 80 μg, 160 μg

Intervention Type: DRUG

OLP-1002 (Test): Part B, Multiple Ascending Dose

Subcutaneous Injection: 5 x 2 μg, 5 x 5 μg, 5 x 10 μg, 5 x 20 μg, 5 x 40 μg, 5 x 80 μg

Intervention Type: DRUG

Placebo: Placebo Part A, Single Ascending Dose

Subcutaneous Injection: Placebo

Intervention Type: OTHER

Placebo: Placebo Part B, Multiple Ascending Dose

Subcutaneous Injection: Placebo x 5

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

OliPass Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Firas Almazedi, MBChB, MSc, CPI, DipPharmMed

Role: PRINCIPAL_INVESTIGATOR

Covance CRU Leeds

Locations

Leeds CRU

Leeds, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

OLP-1002-001

Identifier Type: -

Identifier Source: org_study_id