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. The study consists of: * 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
Study drug: OLP-1002 Proposed Dose: 1. 5 microgram twice a week (BIW) for 15 days (Day 1, 4, 8, 11 and 15) 2. 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
10 patients will receive 5 µg OLP-1002 twice-weekly (BIW) OLP-1002
10 patients will receive 10 µg OLP-1002 BIW OLP-1002
10 patients will receive Placebo BIW
Paratus Clinical Research- Canberra Trial Clinic
Canberra, Australian Capital Territory, Australia
Paratus Clinical Research Western Sydney
Blacktown, New South Wales, Australia
Novatrials (Pendlebury Research)
Newcastle, New South Wales, Australia
Emeritus Research
Camberwell, Victoria, Australia
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Monitored from Screening Visit till the end of the study visit(day 45).
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
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.
Measured by Visual Analogue Scale (VAS)- Worst daily pain intensity
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)
Parameter: trough concentration (Ctrough); sample type used for these analysis: serum sample
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.
Measured by Change from Baseline in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
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.
Measured by Change from Baseline in Hip Injury and Osteoarthritis Outcome Score (HOOS) QoL Subscale
Time frame: Monitored on Day 8, 15, 25, 32 and 45
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