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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Placebo Part A, Single Ascending Dose | Placebo Comparator | Subcutaneous Injection: Placebo |
|
| Placebo Part B, Multiple Ascending Dose | Placebo Comparator | Subcutaneous Injection: Placebo x 5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Firas Almazedi, MBChB, MSc, CPI, DipPharmMed | Covance CRU Leeds | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leeds CRU | Leeds | LS2 9LH | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Part A, Single Ascending Dose | Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo |
| FG001 | 30 ng OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng |
| FG002 | 120 ng OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng |
| FG003 | 400 ng OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng |
| FG004 | 1.2 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg |
| FG005 | 3 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg |
| FG006 | 6 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg |
| FG007 | 12 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg |
| FG008 | 20 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg |
| FG009 | 40 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg |
| FG010 | 80 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg |
| FG011 | 160 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg |
| FG012 | 5 x Placebo Part B, Multiple Ascending Dose | Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5 |
| FG013 | 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg |
| FG014 | 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg |
| FG015 | 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg |
| FG016 | 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg |
| FG017 | 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg |
| FG018 | 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Part A, Single Ascending Dose | Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo |
| BG001 | 30 ng OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety Population | Posted | Count of Participants | Participants | Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days. |
|
Part A: From Screening until Poststudy (Day 28 ±2 days); Part B: From Screening until Poststudy (Day 57 ±2 days)
The condition of each participant was monitored from the time of signing informed consent form to final discharge from the study. Participants were observed for any signs or symptoms 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. Participants were also encouraged to spontaneously report adverse events occurring at any other time during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Part A, Single Ascending Dose | Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| OliPass Call Center | OliPass Corporation | 82-2-6488-2200 | clinicaltrials.inquiries@olipass.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 27, 2019 | Jun 9, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 10, 2019 | Jun 9, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This will be a double-blind, randomized, placebo-controlled, single and multiple subcutaneous dose study.
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double-blind
| 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 |
|
| Placebo: Placebo Part A, Single Ascending Dose | Other | Subcutaneous Injection: Placebo |
|
| Placebo: Placebo Part B, Multiple Ascending Dose | Other | Subcutaneous Injection: Placebo x 5 |
|
| 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. |
| BG002 | 120 ng OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng |
| BG003 | 400 ng OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng |
| BG004 | 1.2 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg |
| BG005 | 3 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg |
| BG006 | 6 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg |
| BG007 | 12 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg |
| BG008 | 20 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg |
| BG009 | 40 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg |
| BG010 | 80 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg |
| BG011 | 160 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg |
| BG012 | 5 x Placebo Part B, Multiple Ascending Dose | Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5 |
| BG013 | 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg |
| BG014 | 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg |
| BG015 | 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg |
| BG016 | 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg |
| BG017 | 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg |
| BG018 | 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg |
| BG019 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Body Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng |
| OG002 | 120 ng OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng |
| OG003 | 400 ng OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng |
| OG004 | 1.2 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg |
| OG005 | 3 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg |
| OG006 | 6 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg |
| OG007 | 12 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg |
| OG008 | 20 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg |
| OG009 | 40 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg |
| OG010 | 80 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg |
| OG011 | 160 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg |
| OG012 | 5 x Placebo Part B, Multiple Ascending Dose | Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5 |
| OG013 | 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg |
| OG014 | 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg |
| OG015 | 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg |
| OG016 | 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg |
| OG017 | 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg |
| OG018 | 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg |
|
|
| Primary | 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. | Safety Population | Posted | Count of Participants | Participants | Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days. |
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| Primary | 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. | Safety Population | Posted | Count of Participants | Participants | Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days. |
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|
|
| Primary | 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. | Safety Population | Posted | Count of Participants | Participants | Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days. |
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| Primary | 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. | Safety Population | Posted | Count of Participants | Participants | Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days. |
|
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| Primary | 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 | Safety Population | Posted | Count of Participants | Participants | Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days. |
|
|
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| Primary | 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. | Safety Population | Posted | Count of Participants | Participants | Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days. |
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| Primary | 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. | Safety Population | Posted | Count of Participants | Participants | Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days. |
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|
| Primary | 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. | Safety Population. Plasma concentrations of OLP-1002 were not analyzed for the groups receiving single doses of 30 ng, 120 ng, 400 ng, 1.2 µg, and 3 µg OLP-1002 and were assumed also to be below the lower limit of quantification/limit of detection. Day 13 assessments were not applicable for Part A of the study. | Posted | Count of Participants | Participants | Part A: Day 1 postdose. Part B: Day 1 postdose and Day 13 postdose. |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 7 |
| 17 |
| EG001 | 30 ng OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | 120 ng OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng | 0 | 6 | 0 | 6 | 2 | 6 |
| EG003 | 400 ng OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng | 0 | 3 | 0 | 3 | 0 | 3 |
| EG004 | 1.2 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg | 0 | 6 | 0 | 6 | 0 | 6 |
| EG005 | 3 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg | 0 | 3 | 0 | 3 | 1 | 3 |
| EG006 | 6 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg | 0 | 6 | 0 | 6 | 2 | 6 |
| EG007 | 12 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg | 0 | 3 | 0 | 3 | 0 | 3 |
| EG008 | 20 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg | 0 | 3 | 0 | 3 | 0 | 3 |
| EG009 | 40 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg | 0 | 6 | 0 | 6 | 3 | 6 |
| EG010 | 80 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg | 0 | 6 | 0 | 6 | 5 | 6 |
| EG011 | 160 µg OLP-1002: Part A, Single Ascending Dose | OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg | 0 | 6 | 0 | 6 | 3 | 6 |
| EG012 | 5 x Placebo Part B, Multiple Ascending Dose | Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5 | 0 | 12 | 0 | 12 | 7 | 12 |
| EG013 | 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg | 0 | 6 | 0 | 6 | 3 | 6 |
| EG014 | 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg | 0 | 6 | 0 | 6 | 4 | 6 |
| EG015 | 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg | 0 | 6 | 0 | 6 | 5 | 6 |
| EG016 | 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg | 0 | 6 | 0 | 6 | 4 | 6 |
| EG017 | 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg | 0 | 6 | 0 | 6 | 6 | 6 |
| EG018 | 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg | 0 | 6 | 0 | 6 | 5 | 6 |
| Dizziness | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
|
| Medical device site rash | General disorders | MedDRA (22.1) | Systematic Assessment | General disorders and administration site conditions |
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| Catheter site pain | General disorders | MedDRA (22.1) | Systematic Assessment | General disorders and administration site conditions |
|
| Infusion site erythema | General disorders | MedDRA (22.1) | Systematic Assessment | General disorders and administration site conditions |
|
| Medical device site erythema | General disorders | MedDRA (22.1) | Systematic Assessment | General disorders and administration site conditions |
|
| Medical device site irritation | General disorders | MedDRA (22.1) | Systematic Assessment | General disorders and administration site conditions |
|
| Medical device site pruritus | General disorders | MedDRA (22.1) | Systematic Assessment | General disorders and administration site conditions |
|
| Vessel puncture site pain | General disorders | MedDRA (22.1) | Systematic Assessment | General disorders and administration site conditions |
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| Nasopharyngitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
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| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
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| Sunburn | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA (22.1) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (22.1) | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
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| Head discomfort | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
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| Poor quality sleep | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
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| Gingival swelling | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
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| Tongue ulceration | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA (22.1) | Systematic Assessment | General disorders and administration site conditions |
|
| Injection site pain | General disorders | MedDRA (22.1) | Systematic Assessment | General disorders and administration site conditions |
|
| Injection site paraesthesia | General disorders | MedDRA (22.1) | Systematic Assessment | General disorders and administration site conditions |
|
| Injection site pruritus | General disorders | MedDRA (22.1) | Systematic Assessment | General disorders and administration site conditions |
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| Non-cardiac chest pain | General disorders | MedDRA (22.1) | Systematic Assessment | General disorders and administration site conditions |
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| Thirst | General disorders | MedDRA (22.1) | Systematic Assessment | General disorders and administration site conditions |
|
| Urinary tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
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| Blister | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
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| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA (22.1) | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (22.1) | Systematic Assessment |
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The Principal Investigator shall not use the name, trademark or the name of any representative of the other, or the existence of their agreement with the sponsor for any promotional or advertising purposes, or any other publication, without the prior written consent of the sponsor, or state or imply that the sponsor endorses or approves any service, material, product or compound of the sponsor without the prior written consent of the sponsor.
| Systolic blood pressure (mmHg) |
|
| Maximum increase from baseline in QTcB greater than 30 milliseconds |
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| Maximum postdose QTcF greater than 450 milliseconds |
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| Maximum increase from baseline in QTcF greater than 30 milliseconds |
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| Sunburn (clinically significant, not related to study drug) |
|
| Papule (clinically significant, not related to study drug) |
|
| Tongue ulceration (clinically significant, not related to study drug) |
|
| Gingival swelling (clinically significant, not related to study drug) |
|
| Pain : Grade 2 (interferes with activity or repeated use of non-narcotic pain reliever) |
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| Tenderness : Grade 1 (mild pain to touch) |
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| Tenderness : Grade 2 (moderate pain to touch) |
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| Redness : Grade 1 (25-50 mm) |
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| Redness : Grade 2 (51-100 mm) |
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| Swelling : Grade 1 (25-50 mm) |
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| Swelling : Grade 2 (51-100 mm or interferes with activity) |
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| Bruising : Present |
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| Day 13 Postdose |
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