Early Phase 1
N=116
OLP-1002 is Being Studied in the Treatment of Pain.
Pain
Bottom Line
View on ClinicalTrials.gov: NCT03760913 ↗Enrolled (actual)
116
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Number of Participants With Adverse Events Stratified by Overall and Severity — 7; 3; 2; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- OLP-1002 (Test): Part A, Single Ascending Dose (Drug); OLP-1002 (Test): Part B, Multiple Ascending Dose (Drug); Placebo: Placebo Part A, Single Ascending Dose (Other); Placebo: Placebo Part B, Multiple Ascending Dose (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- OliPass Corporation
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events Stratified by Overall and Severity |
7; 3; 2; 0; 0; 1 | — |
| PRIMARY Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY 12-lead Electrocardiogram Parameters |
0; 0; 2; 0; 0; 0 | — |
| PRIMARY Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Full and Symptom-Directed Physical Examination Results |
0; 0; 1; 0; 0; 0 | — |
| PRIMARY Number of Participants With Injection Site Assessment Results |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies |
0; 0; 0; 4; 6; 0 | — |
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.
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 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 9.0.
Data sourced from ClinicalTrials.gov (NCT03760913). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.