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

OliPass Corporation2 个研究点分布在 1 个国家目标入组 116 人开始时间: 2018年11月21日最近更新: 2021年8月26日

适应症

试验速览

阶段: 早期 1 期
状态: 已完成
发起方: OliPass Corporation
入组人数: 116
试验地点: 2
主要终点: Number of Participants With Adverse Events Stratified by Overall and Severity

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Investigator)

盲法说明

double-blind

入排标准

年龄范围: 18 Years 至 60 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•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.

排除标准

•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.