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

NCT03760913 | Completed Early Phase 1 Results DMC

• 1 other identifier: OLP-1002-001
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pain; Pain Injection

Outcome Measures

Primary Outcomes (9)

• Number of Participants With Adverse Events Stratified by Overall and Severity

  Participants were observed for any signs or symptoms of adverse events and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit.

  Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.

• Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure

  Number of participants who experienced clinically important changes from baseline (the last value recorded prior to first dose) to scheduled timepoints in supine diastolic and systolic blood pressure. Participants were supine for at least 5 minutes before blood pressure measurements. Blood pressure was measured in triplicate and the time of measurement are below: Single ascending dose: Predose, 1, 2, 4, 8, 24 (± 1 hours), and 48 hours posdose Multiple ascending dose: Day 1 (Predose, 1, 2, 4, and 8 hours postdose), Day 2, Day 4 (postdose), Day 5, Day 7 (postdose), Day 9, Day 10 (postdose), Day 12, Day 13 (predose, 1, 2, 4, and 8 hours postdose), and Day 15 No treatment or dose related trends and no clinically significant changes were observed in mean or individual participant supine blood pressure. Supine diastolic blood pressure reference range: 90 to 140 mmHg. Supine systolic blood pressure reference range: 50 to 90 mmHg.

  Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.

• Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate

  Number of participants who experienced clinically important changes from baseline (the last value recorded prior to first dose) to scheduled timepoints in supine pulse rate. Participants were supine for at least 5 minutes before pulse rate measurements. Pulse rate was measured in triplicate and the time of measurement are below: Single ascending dose: Predose, 1, 2, 4, 8, 24 (± 1 hours), and 48 hours posdose Multiple ascending dose: Day 1 (Predose, 1, 2, 4, and 8 hours postdose), Day 2, Day 4 (postdose), Day 5, Day 7 (postdose), Day 9, Day 10 (postdose), Day 12, Day 13 (predose, 1, 2, 4, and 8 hours postdose), and Day 15 No treatment or dose related trends and no clinically significant changes were observed in mean or individual participant supine pulse rate. Reference range: 40 to 100 beats per minute.

  Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.

• Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate

  Number of participants who experienced clinically important changes from baseline (the last value recorded prior to first dose) to scheduled timepoints in respiratory rate. Participants were supine for at least 5 minutes before respiratory rate measurements. Respiratory rate was measured in triplicate and the time of measurement are below: Single ascending dose: Predose, 1, 2, 4, 8, 24 (± 1 hours), and 48 hours posdose Multiple ascending dose: Day 1 (Predose, 1, 2, 4, and 8 hours postdose), Day 2, Day 4 (postdose), Day 5, Day 7 (postdose), Day 9, Day 10 (postdose), Day 12, Day 13 (predose, 1, 2, 4, and 8 hours postdose), and Day 15 No treatment or dose related trends and no clinically significant changes were observed in mean or individual participant respiratory rate. Reference range: 10 to 24 breaths per minute.

  Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.

• 12-lead Electrocardiogram Parameters

  Resting 12-lead electrocardiogram parameters were recorded after the participant had been supine and at rest for at least 5 minutes. Baseline: the last value recorded prior to first dose; QTcB: QT interval corrected for heart rate using Bazett's formula; QTcF: QT interval corrected for heart rate using Fridericia's method.

  Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.

• Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results

  Number of participants with findings of clinical importance in clinical chemistry, hematology, and urinalysis test results. Clinical laboratory evaluations included: Clinical chemistry: Alanine aminotransferase; Albumin; Alkaline phosphatase; Aspartate aminotransferase; Calcium; Chloride; Cholesterol; Creatinine; Direct bilirubin; Gamma-glutamyl transferase; Glucose; Inorganic phosphate; Potassium; Sodium; Total bilirubin; Total protein; Urea Hematology: Hematocrit; Hemoglobin; Mean cell hemoglobin; Mean cell hemoglobin concentration; Mean cell volume; Platelet count; Red blood cell count; White blood cell count; White blood cell differential (Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils) Urinalysis: Blood; Glucose; Ketones; pH; Protein; Specific gravity; Urobilinogen; Microscopic examination

  Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.

• Number of Participants With Full and Symptom-Directed Physical Examination Results

  A full physical examination and symptom-directed physical examinations were performed at specified timepoints.

  Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.

• Number of Participants With Injection Site Assessment Results

  Evaluation of the dosing site for the following: Pain: Grade 0 to 4 Redness (assessed by estimating the size of the red patch at the injection site across its widest point): Grade 0: 0-24 mm; Grade 1: 25-50 mm; Grade 2: 51-100 mm; Grade 3: More than 100 mm; Grade 4: Requires medical intervention greater than analgesia Swelling (assessed by estimating the size of the raised area around the injection site across its widest point): Grade 0: 0-24 mm; Grade 1: 25-50 mm and does not interfere with activity; Grade 2: 51-100 mm or interferes with activity; Grade 3: More than 100 mm and prevents daily activity; Grade 4: Requires medical intervention greater than analgesia Tenderness: Grade 0 to 4 Bruising and ulceration were evaluated as present or absent.

  Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.

• Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies

  Participants were assessed to demonstrate that exposure to OLP-1002 did not exceed pre-defined exposure limits from non-clinical studies. Participants with temporary detected plasma concentrations between the low limit of detection \[0.2 ng/mL\] and lower limit of quantification \[1 ng/mL\] are presented in the results.

  Part A: Day 1 postdose. Part B: Day 1 postdose and Day 13 postdose.

Study Arms (4)

OLP-1002: Part A, Single Ascending Dose

EXPERIMENTAL

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

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

OLP-1002: Part B, Multiple Ascending Dose

EXPERIMENTAL

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

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

Placebo Part A, Single Ascending Dose

PLACEBO COMPARATOR

Subcutaneous Injection: Placebo

Other: Placebo: Placebo Part A, Single Ascending Dose

Placebo Part B, Multiple Ascending Dose

PLACEBO COMPARATOR

Subcutaneous Injection: Placebo x 5

Other: Placebo: Placebo Part B, Multiple Ascending Dose

Interventions

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

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

OLP-1002: Part B, Multiple Ascending Dose

Placebo: Placebo Part A, Single Ascending Dose OTHER

Subcutaneous Injection: Placebo

Placebo Part A, Single Ascending Dose

Placebo: Placebo Part B, Multiple Ascending Dose OTHER

Subcutaneous Injection: Placebo x 5

Placebo Part B, Multiple Ascending Dose

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OliPass Corporation: lead

Study Sites (1)

Leeds CRU

Leeds, LS2 9LH, United Kingdom

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: OliPass Call Center
• Organization: OliPass Corporation

clinicaltrials.inquiries@olipass.com

82-2-6488-2200

Study Officials

• Firas Almazedi, MBChB, MSc, CPI, DipPharmMed

  Covance CRU Leeds

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This will be a double-blind, randomized, placebo-controlled, single and multiple subcutaneous dose study.

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 3, 2018
• Study Start: November 21, 2018
• Primary Completion: October 16, 2020
• Study Completion: October 16, 2020
• Last Updated: August 26, 2021
• Results First Posted: August 26, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)