PainEarly Phase 1NCT03760913
OLP-1002 is Being Studied in the Treatment of Pain.
A Early Phase 1 study testing OLP-1002 (Test): Part A, Single Ascending Dose and OLP-1002 (Test): Part B, Multiple Ascending Dose in people with Pain, run by OliPass Corporation at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- OLP-1002 (Test): Part A, Single Ascending Dose and OLP-1002 (Test): Part B, Multiple Ascending Dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Nov 2018to 16 Oct 2020
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- OLP-1002 (Test): Part A, Single Ascending Dose, OLP-1002 (Test): Part B, Multiple Ascending Dose, Placebo: Placebo Part A, Single Ascending Dose, Placebo: Placebo Part B, Multiple Ascending Dose
- Keywords
- Pain, Pain Injection
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLP-1002 (Test): Part A, Single Ascending DoseDrug
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 (Test): Part B, Multiple Ascending DoseDrug
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 DoseOther
Subcutaneous Injection: Placebo
Placebo: Placebo Part B, Multiple Ascending DoseOther
Subcutaneous Injection: Placebo x 5
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: OLP-1002 (Test): Part B, Multiple Ascending Dose |
| Placebo Part A, Single Ascending Dose | Placebo comparator | Subcutaneous Injection: Placebo Receives: Other: Placebo: Placebo Part A, Single Ascending Dose |
| Placebo Part B, Multiple Ascending Dose | Placebo comparator | Subcutaneous Injection: Placebo x 5 Receives: Other: Placebo: Placebo Part B, Multiple Ascending Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Part A: Day 1 postdose. Part B: Day 1 postdose and Day 13 postdose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start21 Nov 2018
- Primary completion16 Oct 2020
- Study completion16 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a double-blind, randomized, placebo-controlled, single and multiple subcutaneous dose study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- OliPass Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Firas Almazedi, MBChB, MSc, CPI, DipPharmMed, Principal investigator, Covance CRU Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760913
- Sponsor's protocol ID
- OLP-1002-001
- Status last verified
- Nov 2020
- First submitted
- 29 Nov 2018
- Last updated
- 26 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03760913
- Acronym / sponsor ID
- OLP-1002-001
- Conditions
- Pain
- Keywords
- Pain, Pain Injection
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- OliPass CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 16 Oct 2020 (actual)
- Study completion
- 16 Oct 2020 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Posted 26 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- This will be a double-blind, randomized, placebo-controlled, single and multiple subcutaneous dose study.
| Arm | Type | Receives |
|---|---|---|
| OLP-1002: Part A, Single Ascending Dose | Experimental | Drug: OLP-1002 (Test): Part A, Single Ascending DoseSubcutaneous 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 | Drug: OLP-1002 (Test): Part B, Multiple Ascending DoseSubcutaneous 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 | Other: Placebo: Placebo Part A, Single Ascending DoseSubcutaneous Injection: Placebo |
| Placebo Part B, Multiple Ascending Dose | Placebo comparator | Other: Placebo: Placebo Part B, Multiple Ascending DoseSubcutaneous Injection: Placebo x 5 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OLP-1002 (Test): Part A, Single Ascending DoseSubcutaneous 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: Part A, Single Ascending Dose |
| OLP-1002 (Test): Part B, Multiple Ascending DoseSubcutaneous 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: Part B, Multiple Ascending Dose |
| Placebo: Placebo Part A, Single Ascending DoseSubcutaneous Injection: Placebo | Other | Placebo Part A, Single Ascending Dose |
| Placebo: Placebo Part B, Multiple Ascending DoseSubcutaneous Injection: Placebo x 5 | Other | Placebo Part B, Multiple Ascending Dose |
Primary outcome
Number of Participants With Adverse Events Stratified by Overall and Severity
Time frame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
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.
Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure
Time frame: 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 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.
Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate
Time frame: 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 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.
Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate
Time frame: 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 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.
12-lead Electrocardiogram Parameters
Time frame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
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.
Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results
Time frame: 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. 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
Number of Participants With Full and Symptom-Directed Physical Examination Results
Time frame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
A full physical examination and symptom-directed physical examinations were performed at specified timepoints.
Number of Participants With Injection Site Assessment Results
Time frame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
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.
Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies
Time frame: Part A: Day 1 postdose. Part B: Day 1 postdose and Day 13 postdose.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Firas Almazedi, MBChB, MSc, CPI, DipPharmMed principal investigator
Covance CRU Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing OLP-1002 (Test): Part A, Single Ascending Dose and OLP-1002 (Test): Part B, Multiple Ascending Dose in people with Pain, run by OliPass Corporation at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events Stratified by Overall and Severity (time frame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.