OsteoarthritisPhase 1NCT04677933

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Multiple Subcutaneous Doses of OLP-1002

A Phase 1 study testing A: OLP-1002 and B: OLP-1002 in people with Osteoarthritis, run by OliPass Australia Pty Ltd at 4 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a Phase 1b, randomised, double-blind, placebo-controlled, parallel study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of multiple SC doses of OLP-1002 in patients who have pain due to moderate to severe osteoarthritis (OA) in a hip and/or knee joint. Read more about this study

Who is it for?: Ages 35 to 65 years
Conditions the study is for: Osteoarthritis
What is being tested?: A: OLP-1002 and B: OLP-1002
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 4 sitesAustralia
Study dates: 3 Jun 2020to 22 Dec 2020
Phase: Phase 1
Are there results?: None posted in the registry

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 35 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female aged greater than or equal to 35 years to lesser than or equal to 65 years as of the date of study enrolment;
Patients must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures;
Patients have a BMI greater than or equal to 18 and less than 40 kg/m2 at Screening;
Patients have pain in (a) hip or knee joint/s, every day for at least one month during the three months prior to Screening;
Patients have a diagnosis of moderate to severe OA of the index hip or knee: moderate to severe osteoarthritis, based on American College of Rheumatology (ACR) criteria with Kellgren Lawrence X-ray grade of at least 3 as diagnosed by the radiologist;
Patients with WOMAC Total Pain subscale score of ≥ 10 in the index hip or knee at Screening;

Show all 21Show fewer

Patients who are willing to discontinue all non-study pain medications except for permitted rescue pain medication for the duration of the study;
Patients agree to maintain their usual levels of activity throughout the course of the study and until End of Study (EOS) (Day 45);
Patients who are willing to abstain from all other intra-articular treatments of the joint and any joint surgery while in the study and until EOS (Day 45);
Patients having clear injection sites, although parts of the body have tattoos;
Patients who are willing and able to comply with study procedures, including the recording of daily questionnaires;
Females must be non-pregnant and non-lactating, and must use acceptable, highly effective double contraception from screening until 90 days after the last dose of study drug. Double contraception is defined as a condom AND one other form of the following:
Established hormonal contraception (for example, approved oral contraceptive pills (OCPs), long-acting implantable hormones, injectable hormones);
A vaginal ring or an intrauterine device (IUD); or
Documented evidence of surgical sterilisation at least 6 months prior to screening (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy for women or vasectomy for men [with appropriate post-vasectomy documentation of the absence of sperm in semen] provided the male partner is a sole partner)
Women not of childbearing potential must be post-menopausal for ≥12 months. Post-menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels ≥ 40 IU/mL at Screening for amenorrhoeic female patients. Females who are abstinent from heterosexual intercourse will also be eligible.
Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not considered highly effective methods of birth control. A patient's complete abstinence for the duration of the study and for 90 days after the last study treatment is acceptable.
Female patients who are in a same-sex relationships are not required to use contraception.
Males must be surgically sterile (greater than 30 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a women of child bearing potential (WOCBP), the patient and his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or using an acceptable, highly effective contraceptive method from Screening until 90 days after the last dose of study drug. Acceptable methods of contraception include the use of condoms and the use of an effective contraceptive for the female partner that includes: OCPs, long acting implantable hormones, injectable hormones, a vaginal ring or an IUD. Patients with same-sex partners (abstinence from penile-vaginal intercourse) are eligible when this is their preferred and usual lifestyle;
WOCBP must have a negative pregnancy test at Screening and Day 1 and be willing to have additional pregnancy tests as required throughout the study;
Males must not donate sperm for at least 90 days after the last dose of study drug.

Who cannot join

Any of the following:
QTcF greater than 450 ms confirmed by repeat ECG measurement
QRS duration greater than 110 ms confirmed by repeat ECG measurement
PR interval greater than 220 ms confirmed by repeat ECG measurement
Findings which would make QTc measurements difficult or QTcF data uninterpretable
History of additional risk factors for torsades de pointes (e.g., heart failure (class III/IV according to the New York Heart Association [NYHA]), hypokalaemia, family history of long QT syndrome)

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Intraarticular treatment injections (including but not limited to corticosteroids, hyaluronic acid, platelet rich plasma, BOTOX®, local anaesthetics) within 3 months prior to the Screening period
Patients who are unable or unwilling to cease the use of all pain medications, prescription, over-the-counter and otherwise, as of the first day of the study Washout Period and until after Day 45 of the study. This includes all opioid and anti-inflammatory medications. This excludes the use of paracetamol provided that a patient is able and willing to utilise a maximum of 2 g of paracetamol per 24-hour period as of the first day of the study Washout Period and until after Day 45 of the study, unless the PI has approved an increased dose up to 4 g;
Use or intend to use TENS machine during the study period, i.e. from screening until after Day 45 of the study;
Any of the following laboratory abnormalities within 14 days of the first treatment day:
Platelet count less than 100,000 cells/mm3
Total neutrophil count less than 1,500 cells/mm3
Serum creatinine greater than or equal to 1.5 x ULN
Alanine aminotransferase (ALT) greater than 3.0 x ULN
Aspartate aminotransferase (AST) greater than 3.0 x ULN
Alkaline phosphatase greater than 2.0 x ULN
Bilirubin greater than 1.5 x ULN
Temperature greater than or equal to 38°C or any other evidence of an infection
History of alcohol or substance abuse or dependence during the 12 months prior to Screening
During the study, alcohol consumption of greater than 21 units per week for males and greater than14 units per week for females will not be allowed. 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 urine drug screen (confirmed by repeat) or alcohol consumption (self-report) higher than the permissible limit, as mentioned above, within the preceding 3 days at Screening or Baseline shall be excluded from the study;
Use or intend to use medication that interacts with CYP3A4 and/or CYP2D6.
Has an allergy or hypersensitivity to the study drug or its components;
Female patients who are pregnant at Screening or are planning on becoming pregnant, or are currently breastfeeding;
Patients with any medical condition or comorbidities that could adversely impact study participation or safety, conduct of the study, or interfere with pain assessments;
Active skin conditions such as dermatitis, allergy, eczema, psoriasis, or abnormal skin healing in any body area;
Patients who have 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;
Depression of moderate severity or more on the Patient Health Questionnaire (PHQ-9 greater than or equal to 10) at the Screening visit;
History of psychotic symptoms requiring antipsychotic treatment, or history of a suicide attempt/s within 180 days prior to Screening;
Arterial or venous thrombus, myocardial infarction, hospital admission for unstable angina, treatment with cardiac angioplasty, or cardiac vessel stenting within 90 days prior to Screening;
Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or C. Positive tests for HIV-1 or -2 antibodies, hepatitis B surface antigen, or hepatitis C antibodies;
Current medical or arthritic condition/s that could interfere with evaluation of the index joint including fibromyalgia, rheumatoid arthritis, or other inflammatory arthropathies;
Patient who has undergone arthroscopic or open surgery to the index joint/s within 180 days of Screening visit;
Patient who has undergone replacement surgery of the index joint/s within 180 days of Screening visit;
The placement of surgical hardware or other foreign body in the treatment joint/s within 180 days of Screening visit;
Use or intend to use any medications/products known to alter the absorption, metabolism, or elimination processes of the study drug, including but not limited to St. John's Wort, within 30 days prior to Screening visit, unless deemed acceptable by the Investigator (or designee);
Use or intend to use any prescription medications/products within 14 days prior to Screening, unless deemed acceptable by the Investigator (or designee). Note: hormone replacement therapy or oral, implantable, injectable, or intrauterine contraceptive concomitant medications are acceptable;
Use or intend to use slow-release medications/products considered to still be active within 14 days prior to Screening, unless deemed acceptable by the Investigator (or designee);
Use or intend to use any non-prescription medications/products including phytotherapeutic/herbal/plant-derived preparations within 14 days prior to Screening visit, unless deemed acceptable by the Investigator (or designee) and Sponsor, or assignee, has given their prior consent;
Patients who are unable or unwilling to cease the use of tobacco- or nicotine-containing products during the study duration and have used tobacco- or nicotine-containing products within 90 days prior to Screening visit;
Receipt of blood products within 60 days prior to Screening visit;
Donation of blood from 90 days prior to Screening, plasma from 14 days prior to Screening, or platelets from 42 days prior to Screening;
Poor peripheral venous access;
Are sponsor employees;
Have participated in a clinical study involving administration of an investigational drug in the past 90 days or 5 half-lives of the study drug, whichever is longer, prior to Screening visit;
Have participated in any trial of a device, supplement, cognitive/behavioural therapy, physiotherapy or active exercise study within 30 days prior to the Screening visit;
Have previously completed or withdrawn from this study or any other study investigating OLP-1002 or have previously received the study drug;
Patients who, in the opinion of the Investigator (or designee), should not participate in this study.

Trial locations and contacts

4 sites in 1 country.

Australia4 sites

Paratus Clinical Research Western Sydney
Blacktown, New South Wales, 2148
Emeritus Research
Camberwell, Victoria, 3124
Paratus Clinical Research- Canberra Trial Clinic
Canberra, Australian Capital Territory, 2617
Novatrials (Pendlebury Research)
Newcastle, New South Wales, 2289

Other trials in Australia

About this study

Official title: A Phase 1b, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Multiple Subcutaneous Doses of OLP-1002 in Patients Who Have Pain Due to Moderate to Severe Osteoarthritis in a Hip and/or Knee Joint

Screening period: up to 14 days (defined as Day -23 to -9)
Washout period: 5 days (± 1 day) (defined as Day -8 to -4)
Baseline period: 3 days (± 1 day) (defined as Day -3 to -1, where Day -1 is the day before dosing)
Treatment period: 15 days (± 1 day) (defined as Day 1 to 15, where Day 1 is the day of first dosing)
Follow-up period: 30 days (± 5 days) (defined as Day 16 to 45, assuming Day 15 is the day of the last dose)

Up to 30 patients will be enrolled in the study and will be randomised in the ratio 1:1:1 to the following arms:

Arm A: 10 patients will receive 5 µg twice-weekly (BIW) OLP-1002
Arm B: 10 patients will receive 10 µg BIW OLP-1002
Arm C: 10 patients will receive Placebo BIW

Read the detailed description

Study drug: OLP-1002

Proposed Dose:

5 microgram twice a week (BIW) for 15 days (Day 1, 4, 8, 11 and 15)
10 microgram BIW for 15 days (Day 1, 4, 8, 11 and 15)

Mode of Administration: Subcutaneous injection

The study will consist of 5 time periods:

Screening period: up to14 days
Washout period: 5 days (± 1 day)
Baseline period: 3 days (± 1 day)
Treatment period: 15 days (± 1 day)
Follow-up period: 30 days from last dose (± 5 days)

Up to 30 patients will be enrolled in the study and will be randomised in the ratio 1:1:1 to the following arms:

Arm A: 10 patients will receive 5 µg BIW OLP-1002
Arm B: 10 patients will receive 10 µg BIW OLP-1002
Arm C: 10 patients will receive Placebo BIW

Conditions: Osteoarthritis
Being tested: A: OLP-1002, B: OLP-1002, C: Placebo
Medical subject headings: Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

A: OLP-1002Drug
Also called OLP-1002: A
10 patients will receive 5 µg OLP-1002 twice-weekly (BIW) OLP-1002
B: OLP-1002Drug
Also called OLP-1002: B
10 patients will receive 10 µg OLP-1002 BIW OLP-1002
C: PlaceboDrug
Also called Placebo
10 patients will receive Placebo BIW

Study groups in NCT04677933
Study group	Role	What they receive
Arm A	Experimental	Patients will receive 5 µg OLP-1002 BIW for 15 days (Day 1, 4, 8, 11 and 15). Mode of Administration: Subcutaneous injection Receives: Drug: A: OLP-1002
Arm B	Experimental	Patients will receive 10 µg OLP-1002 BIW for 15 days (Day 1, 4, 8, 11 and 15). Mode of Administration: Subcutaneous injection Receives: Drug: B: OLP-1002
Arm C	Experimental	Patients will receive Diluent placebo BIW for 15 days (Day 1, 4, 8, 11 and 15) Mode of Administration: Subcutaneous injection Receives: Drug: C: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Treatment- Emergent Adverse Events(Safety and Tolerability) of OLP-1002 in patients who have pain in a hip and/or knee joint
Number of participants with treatment-related adverse events as assessed by CTCAE
Measured: Monitored from Screening Visit till the end of the study visit(day 45).
Safety and tolerability (Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- heart rate
Measured by result of the Vital Sign- heart rate
Measured: Monitored from Screening Visit till the end of the study visit(day 45).
Safety and tolerability (Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- blood pressure
Measured by result of the Vital Sign- blood pressure
Measured: Monitored from Screening Visit till the end of the study visit(day 45).
Safety and tolerability (Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- oral temperature
Measured by result of the Vital Sign- oral temperature
Measured: Monitored from Screening Visit till the end of the study visit(day 45).
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through 12-lead ECG
Measured by result of the ECG measurements and findings Parameters: QRS, ST segment, and QTcF.
Measured: Monitored from Screening Visit till the end of the study visit(day 45).
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Physical exam
Measured by result of the physical exam which includes general appearance, head, ears, eyes, nose, throat, dentition, thyroid, chest (heart, lungs), abdomen, skin, neurological, extremities, back, neck, musculoskeletal, and lymph nodes.
Measured: Monitored from Screening Visit till the end of the study visit(day 45).
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Clinical laboratory results
Measured by clinically significant change from baseline clinical laboratory results
Measured: Monitored from Screening Visit till the end of the study visit(day 45).

Secondary outcomes (5)

To evaluate the preliminary efficacy of OLP-1002 on pain, during the treatment and follow-up periods through WOMAC. The minimum and maximum values, and whether higher scores mean a better or worse outcome.
Measured by Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain, Stiffness and Physical Function Subscales together with Total WOMAC Score
Measured: Monitored on Day 4, 8, 11, 15, 18, 25, 32 and 45.
To evaluate the preliminary efficacy of OLP-1002 on pain, during the treatment and follow-up periods through VAS. The minimum and maximum values, and whether higher scores mean a better or worse outcome.
Measured by Visual Analogue Scale (VAS)- Worst daily pain intensity
Measured: Monitored on Day 4, 8, 11, 15, 18, 25, 32 and 45.
To characterize the pharmacokinetic (PK) profile of OLP-1002 trough concentration (Ctrough)
Parameter: trough concentration (Ctrough); sample type used for these analysis: serum sample
Measured: PK samples will be collected pre-dose on days Day 1, 8 and 15 as well as on Day 45
To monitor the effects of multiple SC doses of OLP-1002 on Quality of Life (QoL) through Score (KOOS). The minimum and maximum values, and whether higher scores mean a better or worse outcome.
Measured by Change from Baseline in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measured: Monitored on Day 8, 15, 25, 32 and 45
To monitor the effects of multiple SC doses of OLP-1002 on Quality of Life (QoL) through Score (HOOS) QoL Subscale. The minimum and maximum values, and whether higher scores mean a better or worse outcome.
Measured by Change from Baseline in Hip Injury and Osteoarthritis Outcome Score (HOOS) QoL Subscale
Measured: Monitored on Day 8, 15, 25, 32 and 45

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jun 202022 Dec 2020

First posted21 Dec 2020
Study start3 Jun 2020
Primary completion22 Dec 2020
Study completion22 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for OsteoarthritisStudies 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: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04677933
Sponsor's protocol ID: OLP-1002-001B
Status last verified: Dec 2020
First submitted: 17 Nov 2020
Last updated: 24 Dec 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Multiple Subcutaneous Doses of OLP-1002 in Patients Who Have Pain Due to Moderate to Severe Osteoarthritis in a Hip and/or Knee Joint
ClinicalTrials.gov ID: NCT04677933
Acronym / sponsor ID: OLP-1002-001B
Conditions: Osteoarthritis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: OliPass Australia Pty LtdIndustry (pharma, biotech, devices)
Collaborators: Novotech (Australia) Pty Limited
Study start: 3 Jun 2020 (actual)
Primary completion: 22 Dec 2020 (actual)
Study completion: 22 Dec 2020 (actual)
First posted: 21 Dec 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Screening period: up to 14 days (defined as Day -23 to -9)
Washout period: 5 days (± 1 day) (defined as Day -8 to -4)
Baseline period: 3 days (± 1 day) (defined as Day -3 to -1, where Day -1 is the day before dosing)
Treatment period: 15 days (± 1 day) (defined as Day 1 to 15, where Day 1 is the day of first dosing)
Follow-up period: 30 days (± 5 days) (defined as Day 16 to 45, assuming Day 15 is the day of the last dose)

Up to 30 patients will be enrolled in the study and will be randomised in the ratio 1:1:1 to the following arms:

Arm A: 10 patients will receive 5 µg twice-weekly (BIW) OLP-1002
Arm B: 10 patients will receive 10 µg BIW OLP-1002
Arm C: 10 patients will receive Placebo BIW

Detailed description

Study drug: OLP-1002

Proposed Dose:

5 microgram twice a week (BIW) for 15 days (Day 1, 4, 8, 11 and 15)
10 microgram BIW for 15 days (Day 1, 4, 8, 11 and 15)

Mode of Administration: Subcutaneous injection

The study will consist of 5 time periods:

Screening period: up to14 days
Washout period: 5 days (± 1 day)
Baseline period: 3 days (± 1 day)
Treatment period: 15 days (± 1 day)
Follow-up period: 30 days from last dose (± 5 days)

Up to 30 patients will be enrolled in the study and will be randomised in the ratio 1:1:1 to the following arms:

Arm A: 10 patients will receive 5 µg BIW OLP-1002
Arm B: 10 patients will receive 10 µg BIW OLP-1002
Arm C: 10 patients will receive Placebo BIW

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Arm A	Experimental	Drug: A: OLP-1002Patients will receive 5 µg OLP-1002 BIW for 15 days (Day 1, 4, 8, 11 and 15). Mode of Administration: Subcutaneous injection
Arm B	Experimental	Drug: B: OLP-1002Patients will receive 10 µg OLP-1002 BIW for 15 days (Day 1, 4, 8, 11 and 15). Mode of Administration: Subcutaneous injection
Arm C	Experimental	Drug: C: PlaceboPatients will receive Diluent placebo BIW for 15 days (Day 1, 4, 8, 11 and 15) Mode of Administration: Subcutaneous injection

Who may qualify

Ages: 35 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (21 listed)

Male or female aged greater than or equal to 35 years to lesser than or equal to 65 years as of the date of study enrolment;
Patients must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures;
Patients have a BMI greater than or equal to 18 and less than 40 kg/m2 at Screening;
Patients have pain in (a) hip or knee joint/s, every day for at least one month during the three months prior to Screening;
Patients have a diagnosis of moderate to severe OA of the index hip or knee: moderate to severe osteoarthritis, based on American College of Rheumatology (ACR) criteria with Kellgren Lawrence X-ray grade of at least 3 as diagnosed by the radiologist;

Key exclusion criteria (48 listed)

Any of the following:
Intraarticular treatment injections (including but not limited to corticosteroids, hyaluronic acid, platelet rich plasma, BOTOX®, local anaesthetics) within 3 months prior to the Screening period
Patients who are unable or unwilling to cease the use of all pain medications, prescription, over-the-counter and otherwise, as of the first day of the study Washout Period and until after Day 45 of the study. This includes all opioid and anti-inflammatory medications. This excludes the use of paracetamol provided that a patient is able and willing to utilise a maximum of 2 g of paracetamol per 24-hour period as of the first day of the study Washout Period and until after Day 45 of the study, unless the PI has approved an increased dose up to 4 g;
Use or intend to use TENS machine during the study period, i.e. from screening until after Day 45 of the study;
Any of the following laboratory abnormalities within 14 days of the first treatment day:

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
A: OLP-1002Also: OLP-1002: A10 patients will receive 5 µg OLP-1002 twice-weekly (BIW) OLP-1002	Drug	Arm A
B: OLP-1002Also: OLP-1002: B10 patients will receive 10 µg OLP-1002 BIW OLP-1002	Drug	Arm B
C: PlaceboAlso: Placebo10 patients will receive Placebo BIW	Drug	Arm C

Primary outcome

Incidence of Treatment- Emergent Adverse Events(Safety and Tolerability) of OLP-1002 in patients who have pain in a hip and/or knee joint
Time frame: Monitored from Screening Visit till the end of the study visit(day 45).
Number of participants with treatment-related adverse events as assessed by CTCAE
Safety and tolerability (Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- heart rate
Time frame: Monitored from Screening Visit till the end of the study visit(day 45).
Measured by result of the Vital Sign- heart rate
Safety and tolerability (Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- blood pressure
Time frame: Monitored from Screening Visit till the end of the study visit(day 45).
Measured by result of the Vital Sign- blood pressure
Safety and tolerability (Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- oral temperature
Time frame: Monitored from Screening Visit till the end of the study visit(day 45).
Measured by result of the Vital Sign- oral temperature
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through 12-lead ECG
Time frame: Monitored from Screening Visit till the end of the study visit(day 45).
Measured by result of the ECG measurements and findings Parameters: QRS, ST segment, and QTcF.
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Physical exam
Time frame: Monitored from Screening Visit till the end of the study visit(day 45).
Measured by result of the physical exam which includes general appearance, head, ears, eyes, nose, throat, dentition, thyroid, chest (heart, lungs), abdomen, skin, neurological, extremities, back, neck, musculoskeletal, and lymph nodes.
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Clinical laboratory results
Time frame: Monitored from Screening Visit till the end of the study visit(day 45).
Measured by clinically significant change from baseline clinical laboratory results

5 secondary outcomes

To evaluate the preliminary efficacy of OLP-1002 on pain, during the treatment and follow-up periods through WOMAC. The minimum and maximum values, and whether higher scores mean a better or worse outcome.
Time frame: Monitored on Day 4, 8, 11, 15, 18, 25, 32 and 45.
To evaluate the preliminary efficacy of OLP-1002 on pain, during the treatment and follow-up periods through VAS. The minimum and maximum values, and whether higher scores mean a better or worse outcome.
Time frame: Monitored on Day 4, 8, 11, 15, 18, 25, 32 and 45.
To characterize the pharmacokinetic (PK) profile of OLP-1002 trough concentration (Ctrough)
Time frame: PK samples will be collected pre-dose on days Day 1, 8 and 15 as well as on Day 45
To monitor the effects of multiple SC doses of OLP-1002 on Quality of Life (QoL) through Score (KOOS). The minimum and maximum values, and whether higher scores mean a better or worse outcome.
Time frame: Monitored on Day 8, 15, 25, 32 and 45
To monitor the effects of multiple SC doses of OLP-1002 on Quality of Life (QoL) through Score (HOOS) QoL Subscale. The minimum and maximum values, and whether higher scores mean a better or worse outcome.
Time frame: Monitored on Day 8, 15, 25, 32 and 45

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.

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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.

Andrew Ostor principal investigator

Emeritus Research

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing A: OLP-1002 and B: OLP-1002 in people with Osteoarthritis, run by OliPass Australia Pty Ltd at 4 sites in Australia.

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 21 inclusion and 48 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 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Australia. 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. 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of Treatment- Emergent Adverse Events(Safety and Tolerability) of OLP-1002 in patients who have pain in a hip and/or knee joint (time frame: Monitored from Screening Visit till the end of the study visit(day 45).). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04677933.

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 24 Dec 2020.