Healthy VolunteersPhase 1NCT03227796
Safety, Tolerability & Pharmacokinetics of LEVI-04 in Healthy Volunteers and Patients With Osteoarthritis Knee Pain
A Phase 1 study testing LEVI-04 in people with Healthy Volunteers and Osteoarthritis, run by Levicept at 2 sites in United Kingdom.
Trial summary
This is a first-in-human, phase 1, single centre, placebo-controlled, double-blind, single ascending dose study of LEVI-04 in heathy volunteers and osteoarthritis patients (with pain attributed to osteoarthritis of the knee) Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Osteoarthritis
- What is being tested?
- LEVI-04
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 28 Jul 2017to 31 Mar 2021
- 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 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index 18.0-<32.0 kg/m2 (healthy volunteers) and 18.0-<40.0 kg/m2 (osteoarthritis patients)
- Willing and able to give written fully informed consent
- Men with female partners of childbearing potential must agree to follow the requirements for effective contraception throughout the study and for 112 days post-dose
- Women of non childbearing potential
- Healthy volunteers (aged 18 to 65 years) willing to give written consent to have data entered into the Over-volunteering Prevention System
- Osteoarthritis patients (aged 30-80 years) with diagnosis of mild to moderate osteoarthritis of the knee, with X-ray confirmation as diagnosed by a trained radiology reviewer
- Osteoarthritis patients willing to discontinue all pain medication, except rescue medication (paracetamol), from the run-in visit until the end of the study
- Osteoarthritis patients with a Numerical Rating Scale-11 pain score of between 5 and <9, inclusive, in the index knee at screening. If taking regular pain medication, should show an increase of at least 1 point following washout of analgesia. The average pain score of between 5 and <9, inclusive, based on four of the seven daily readings during the seven day initial pain assessment period
Who cannot join
- Women of childbearing potential, or who are pregnant or lactating
- Clinically relevant abnormal history, physical findings, electrocardiograph, or laboratory values at screening that could interfere with the objectives of the trial or the safety of the subject
- Presence of acute or chronic illness or history of chronic illness (other than osteoarthritis, controlled diabetes, asthma or hypertension for osteoarthritis patients), sufficient to invalidate participation in the trial or make it unnecessarily hazardous
- Impaired endocrine, thyroid, hepatic, respiratory (other than asthma that has been controlled by the use of acceptable medication for at least 3 months prior to screening) or renal function; or history of any psychotic mental illness or clinically significant psychiatric disorder
- History of carpal tunnel syndrome with signs or symptoms within one year before screening or a Boston Carpal Tunnel Questionnaire score >3
- Moderate or severe carpal tunnel syndrome based on the 4th finger neurological test or Total Neuropathy Score nurse
Show all 48Show fewer
- History of cancer within 5 years before screening, except for appropriately treated cutaneous basal cell or squamous cell cancers; cervical cancer; and low grade stable prostate cancer
- History, diagnosis, or signs of neurological disease including but not limited to: stroke; peripheral or autonomic neuropathy; diabetic neuropathy; multiple sclerosis; epilepsy or seizure disorder with history of seizure within last 2 years; myopathy; Alzheimer's disease or other types of dementia; head trauma within last 2 years; and episodic lower limb radiculopathy, nerve compression, or sciatica (provided diagnosed as due to nerve root compression and not as a manifestation of systemic neuropathy or radiculopathy)
- Survey of Autonomic Symptoms score of at least 3
- Uncontrolled type 1 diabetes or type 2 diabetes with HbA1c <7.5% (type 1 diabetics and type 2 diabetics that have been controlled by acceptable medication for at least three months prior to screening are permitted if HbA1c < 7.5%).
- History or signs and symptoms of coronary heart disease or stroke
- QTcF interval <330 msec or ≥430 msec for males, and ≥450 msec for females at the screening examination, unless judged not clinically significant by an investigator
- Presence of Chronic Obstructive Pulmonary Disease
- Moderate / severe depression indicated by a score of ≥10 out of 24 in the Personal Health Questionnaire Depression Scale
- History or presence of severe adverse reaction to any drug or a history of sensitivity to mannitol or histidine
- Use of prescription medicine (other than the permitted medicines) during 28 days before the dose of trial medication (14 days for pain medication for osteoarthritis patients)
- Use of an over-the-counter medicine, except paracetamol, during the 7 days before the first dose of trial medication
- Dosed in another clinical trial of a new chemical entity or prescription medicine within last 3 months
- Previous use of any Tropomyosin-receptor kinase (TrkA) inhibitor, Nerve Growth Factor-targeted therapy (eg tanezumab), or experimental biological treatment in last 6 months. More than 6 doses of anti- nerve growth factor (NGF) antibody during participation in a trial is not permitted.
- History / presence of drug / alcohol abuse in year before screening, or intake of >28 units of alcohol weekly or currently smoking >10 cigarettes daily
- Evidence of drug abuse
- Uncontrolled hypertension (supine) at screening outside 90-140 mm Hg systolic, 40-90 mm Hg diastolic; heart rate in supine position at screening outside 40-100 beats/min. (Diagnosed hypertension that has been controlled within the above limits using acceptable medication for at least 3 months prior to screening is permitted.)
- Possibility that will not cooperate with requirements of the trial
- Positive test for hepatitis B, hepatitis C or Human Immunodeficiency Virus
- Loss of more than 400mL blood during last 3 months, eg as a blood donor
- Objection by General Practitioner to trial entry
- Poor venous access
- Also for osteoarthritis patients:
- History of inflammatory arthritis, including rheumatoid arthritis, seronegative spondyloarthropathy (eg ankylosing spondylitis, psoriatic arthritis, inflammatory bowel disease related arthropathy), gout, pseudogout in index knee (as diagnosed by appropriate crystals on aspiration or C-reactive protein elevation during attacks (subjects with gout or pseudogout in a joint other than the index knee must have disease that is controlled by medication, with a serum uric acid within the target range; should their index knee flare up during the study, gout must be excluded), metabolic joint disease, endocrinopathy, lupus erythematosus, joint infection, connective tissue disease, septic arthritis
- Radiographic evidence of:
- excessive malalignment of the knee
- severe chondrocalcinosis or other arthropathies (eg rheumatoid arthritis)
- systemic metabolic bone disease (eg pseudogout, Paget's disease, metastatic calcifications)
- large cystic lesions, primary or metastatic tumour lesions
- acute or healing stress or traumatic fracture (subjects with established united/ malunited intra or extra-articular fractures of the knee from historic injuries [>12 months prior to screening] who have developed features of post-traumatic osteoarthritis can be included in the trial, provided that clinically and radiologically there is no excessive malalignment of the knee)
- Rapidly Progressive Osteoarthritis, or any condition which would indicate an increased risk for developing it
- atrophic or hypotrophic osteoarthritis
- subchondral insufficiency fractures
- spontaneous osteonecrosis of the knee
- osteonecrosis
- pathologic fracture
- History of osteonecrosis / osteoporotic fracture (including minimally traumatic or atraumatic fracture)
- History of significant trauma (including sports injury) or surgery to a knee, hip or shoulder within last year
- Planned surgery to a knee, hip or shoulder during the study
- Fibromyalgia, regional pain caused by lumbar / cervical compression with radiculopathy, or other moderate/severe pain that may confound assessment of knee pain
- Intra-articular injection of corticosteroid in the index knee within 3 months, or to any other joint within 1 month of the initial pain assessment
- Intra-articular injection of any hyaluronan product in the index knee within 6 months before the initial pain assessment
- Any other medical or psychiatric condition, or laboratory abnormality, that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator would make the subject inappropriate for entry into this study
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Hammersmith Medicines Research
London, NW10 7EW
MAC Clinical Research - Early Phase Unit
Manchester, Greater Manchester, M13 9NQ
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Single Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LEVI-04 in Healthy Volunteers and Patients With Pain Attributed to Osteoarthritis of the Knee
This is a first-in-human, phase 1, single centre, placebo-controlled, double-blind, single ascending dose study of LEVI-04 in heathy volunteers and osteoarthritis patients (with pain attributed to osteoarthritis of the knee)
Read the detailed description
There will be 8 cohorts of 7 subjects each. Cohorts 1-3 and 8 will be composed of healthy volunteers. Cohorts 4-7 will be composed of osteoarthritis patients. Cohort 4 will be a bridging cohort; osteoarthritis patients in Cohort 4 will receive the same dose as the healthy volunteers in Cohort 3, if deemed safe.
Each subject will be assigned to receive a single dose of LEVI-04 or matching placebo. Each dose will be administered as an intravenous infusion over 30 minutes. Planned doses will start at 0.003 mg/kg in Cohort 1, and may be increased to 3.0 mg/kg in Cohort 8. The planned doses may be changed, depending on the safety, tolerability and pharmacokinetic results after previous doses. The dose selected for each cohort will be determined by the Safety Review Team, following review of all available pharmacokinetic and safety data. For each escalating dose, there will be at least 2 weeks between the start of each cohort (at least 14 days between Day 0 for the last subject in the previous cohort and Day 0 for the first subject in the subsequent cohort), to allow for review of safety, tolerability and pharmacokinetic data. In each cohort, 5 subjects will receive LEVI-04 and 2 subjects will receive matching placebo.
- Conditions
- Healthy Volunteers, Osteoarthritis
- Being tested
- LEVI-04, Placebo
- Keywords
- osteoarthritis, knee, healthy, volunteer, LEVI-04
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEVI-04Drug
LEVI-04 intravenous infusion
PlaceboDrug
Placebo intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Healthy Volunteers Active | Experimental | LEVI-04 0.003 mg/kg single intravenous dose Healthy Volunteers Receives: Drug: LEVI-04 |
| Cohort 2 Healthy Volunteers Active | Experimental | LEVI-04 Dose Level 2 (planned 0.01 mg/kg) single intravenous dose Healthy Volunteers Receives: Drug: LEVI-04 |
| Cohort 3 Healthy Volunteers Active | Experimental | LEVI-04 Dose Level 3 (planned 0.03 mg/kg) single intravenous dose Healthy Volunteers Receives: Drug: LEVI-04 |
| Cohort 4 Osteoarthritis Patients Active | Experimental | LEVI-04 Dose Level 3 (planned 0.03 mg/kg) single intravenous dose Osteoarthritis Patients Receives: Drug: LEVI-04 |
| Cohort 5 Osteoarthritis Patients Active | Experimental | LEVI-04 Dose Level 4 (planned 0.1 mg/kg) single intravenous dose Osteoarthritis Patients Receives: Drug: LEVI-04 |
| Cohort 6 Osteoarthritis Patients Active | Experimental | LEVI-04 Dose Level 5 (planned 0.3 mg/kg) single intravenous dose Osteoarthritis Patients Receives: Drug: LEVI-04 |
| Cohort 7 Osteoarthritis Patients Active | Experimental | LEVI-04 Dose Level 6 (planned 1.0 mg/kg) single intravenous dose Osteoarthritis Patients Receives: Drug: LEVI-04 |
| Cohort 8 Healthy Volunteers Active | Experimental | LEVI-04 Dose Level 7 (planned 3.0 mg/kg) single intravenous dose Healthy Volunteers Receives: Drug: LEVI-04 |
| Cohort 1 Healthy Volunteers Placebo | Placebo comparator | Placebo to match LEVI-04 single intravenous dose Healthy Volunteers Receives: Drug: Placebo |
| Cohort 2 Healthy Volunteers Placebo | Placebo comparator | Placebo to match LEVI-04 single intravenous dose Healthy Volunteers Receives: Drug: Placebo |
| Cohort 3 Healthy Volunteers Placebo | Placebo comparator | Placebo to match LEVI-04 single intravenous dose Healthy Volunteers Receives: Drug: Placebo |
| Cohort 4 Osteoarthritis Patients Placebo | Placebo comparator | Placebo to match LEVI-04 single intravenous dose Osteoarthritis Patients Receives: Drug: Placebo |
| Cohort 5 Osteoarthritis Patients Placebo | Placebo comparator | Placebo to match LEVI-04 single intravenous dose Osteoarthritis Patients Receives: Drug: Placebo |
| Cohort 6 Osteoarthritis Patients Placebo | Placebo comparator | Placebo to match LEVI-04 single intravenous dose Osteoarthritis Patients Receives: Drug: Placebo |
| Cohort 7 Osteoarthritis Patients Placebo | Placebo comparator | Placebo to match LEVI-04 single intravenous dose Osteoarthritis Patients Receives: Drug: Placebo |
| Cohort 8 Healthy Volunteers Placebo | Placebo comparator | Placebo to match LEVI-04 single intravenous dose Healthy Volunteers Receives: Drug: 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]
adverse events; laboratory tests; electrocardiograms and injection site reaction assessments
Measured: Change from Baseline at Day 56 post-dose for healthy volunteers and change from Baseline at Day 105 post-dose for osteoarthritis patients
Change from Baseline in neurological assessments [Safety and tolerability] - SAS
Neurological assessment (Survey of Autonomic Symptoms (SAS) Questionnaire)
Measured: Change from Baseline at Day 56 post-dose for healthy volunteers and change from Baseline at Day 105 post-dose for osteoarthritis patients
Change from Baseline in neurological assessments [Safety and tolerability] - BCTQ
Neurological assessment (Boston Carpal Tunnel Questionnaire (BCTQ)
Measured: Change from Baseline at Day 56 post-dose for healthy volunteers and change from Baseline at Day 105 post-dose for osteoarthritis patients
Change from Baseline in neurological assessments [Safety and tolerability] - 4th finger test
Neurological assessment (the carpal tunnel syndrome (CTS) 4th finger neurological test or Total Neuropathy Score nurse)
Measured: Change from Baseline at Day 56 post-dose for healthy volunteers and change from Baseline at Day 105 post-dose for osteoarthritis patients
Secondary outcomes (8)
Pharmacokinetics of single ascending intravenous doses of LEVI-04 in healthy volunteers and osteoarthritis patients - maximum concentration
Maximum serum concentration
Measured: Up to Day 56 post-dose for healthy volunteers and up to Day 105 post-dose for osteoarthritis patients
Pharmacokinetics of single ascending intravenous doses of LEVI-04 in healthy volunteers and osteoarthritis patients - time to maximum concentration
Time to reach maximum serum concentration
Measured: Up to Day 56 post-dose for healthy volunteers and up to Day 105 post-dose for osteoarthritis patients
Pharmacokinetics of single ascending intravenous doses of LEVI-04 in healthy volunteers and osteoarthritis patients - Area Under the Curve
Area under the serum concentration-time curve from time zero to time of last measurable concentration
Measured: Up to Day 56 post-dose for healthy volunteers and up to Day 105 post-dose for osteoarthritis patients
Pharmacokinetics of single ascending intravenous doses of LEVI-04 in healthy volunteers and osteoarthritis patients - half-life
Terminal elimination half-life
Measured: Up to Day 56 post-dose for healthy volunteers and up to Day 105 post-dose for osteoarthritis patients
Pharmacokinetics of single ascending intravenous doses of LEVI-04 in healthy volunteers and osteoarthritis patients - clearance
Apparent total body clearance after intravenous administration
Measured: Up to Day 56 post-dose for healthy volunteers and up to Day 105 post-dose for osteoarthritis patients
Pharmacokinetics of single ascending intravenous doses of LEVI-04 in healthy volunteers and osteoarthritis patients - elimination rate
Terminal elimination rate constant
Measured: Up to Day 56 post-dose for healthy volunteers and up to Day 105 post-dose for osteoarthritis patients
Pharmacokinetics of single ascending intravenous doses of LEVI-04 in healthy volunteers and osteoarthritis patients - volume of distribution
Apparent volume of distribution during the terminal elimination phase
Measured: Up to Day 56 post-dose for healthy volunteers and up to Day 105 post-dose for osteoarthritis patients
To assess the formation of anti-drug antibodies (ADA) to LEVI-04 in healthy volunteers and osteoarthritis patients
Presence / concentration of any anti-drug antibodies to LEVI-04
Measured: Up to Day 56 post-dose for healthy volunteers and up to Day 105 post-dose for osteoarthritis patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start28 Jul 2017
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- First-in-human, phase 1, placebo-controlled, double-blind, single ascending dose study in heathy volunteers and osteoarthritis patients
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Levicept
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hammersmith Medicines Research, MAC Clinical Research
- Responsible party
- Sponsor
- Investigators
- Denisa Wilkes, MUDr, Principal investigator, Hammersmith Medicines Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227796
- Sponsor's protocol ID
- LEVI-04_17_01
- Status last verified
- Apr 2021
- First submitted
- 31 May 2017
- Last updated
- 8 Apr 2021
- Results posted
- No
- 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 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Single Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LEVI-04 in Healthy Volunteers and Patients With Pain Attributed to Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT03227796
- Acronym / sponsor ID
- LEVI-04_17_01
- Conditions
- Healthy Volunteers, Osteoarthritis
- Keywords
- osteoarthritis, knee, healthy, volunteer, LEVI-04
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- LeviceptIndustry (pharma, biotech, devices)
- Collaborators
- Hammersmith Medicines Research, MAC Clinical Research
- Study start
- 28 Jul 2017 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 24 Jul 2017 (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.
This is a first-in-human, phase 1, single centre, placebo-controlled, double-blind, single ascending dose study of LEVI-04 in heathy volunteers and osteoarthritis patients (with pain attributed to osteoarthritis of the knee)
Detailed description
There will be 8 cohorts of 7 subjects each. Cohorts 1-3 and 8 will be composed of healthy volunteers. Cohorts 4-7 will be composed of osteoarthritis patients. Cohort 4 will be a bridging cohort; osteoarthritis patients in Cohort 4 will receive the same dose as the healthy volunteers in Cohort 3, if deemed safe.
Each subject will be assigned to receive a single dose of LEVI-04 or matching placebo. Each dose will be administered as an intravenous infusion over 30 minutes. Planned doses will start at 0.003 mg/kg in Cohort 1, and may be increased to 3.0 mg/kg in Cohort 8. The planned doses may be changed, depending on the safety, tolerability and pharmacokinetic results after previous doses. The dose selected for each cohort will be determined by the Safety Review Team, following review of all available pharmacokinetic and safety data. For each escalating dose, there will be at least 2 weeks between the start of each cohort (at least 14 days between Day 0 for the last subject in the previous cohort and Day 0 for the first subject in the subsequent cohort), to allow for review of safety, tolerability and pharmacokinetic data. In each cohort, 5 subjects will receive LEVI-04 and 2 subjects will receive matching placebo.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 16
- Model description
- First-in-human, phase 1, placebo-controlled, double-blind, single ascending dose study in heathy volunteers and osteoarthritis patients
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Healthy Volunteers Active | Experimental | Drug: LEVI-04LEVI-04 0.003 mg/kg single intravenous dose Healthy Volunteers |
| Cohort 2 Healthy Volunteers Active | Experimental | Drug: LEVI-04LEVI-04 Dose Level 2 (planned 0.01 mg/kg) single intravenous dose Healthy Volunteers |
| Cohort 3 Healthy Volunteers Active | Experimental | Drug: LEVI-04LEVI-04 Dose Level 3 (planned 0.03 mg/kg) single intravenous dose Healthy Volunteers |
| Cohort 4 Osteoarthritis Patients Active | Experimental | Drug: LEVI-04LEVI-04 Dose Level 3 (planned 0.03 mg/kg) single intravenous dose Osteoarthritis Patients |
| Cohort 5 Osteoarthritis Patients Active | Experimental | Drug: LEVI-04LEVI-04 Dose Level 4 (planned 0.1 mg/kg) single intravenous dose Osteoarthritis Patients |
| Cohort 6 Osteoarthritis Patients Active | Experimental | Drug: LEVI-04LEVI-04 Dose Level 5 (planned 0.3 mg/kg) single intravenous dose Osteoarthritis Patients |
| Cohort 7 Osteoarthritis Patients Active | Experimental | Drug: LEVI-04LEVI-04 Dose Level 6 (planned 1.0 mg/kg) single intravenous dose Osteoarthritis Patients |
| Cohort 8 Healthy Volunteers Active | Experimental | Drug: LEVI-04LEVI-04 Dose Level 7 (planned 3.0 mg/kg) single intravenous dose Healthy Volunteers |
| Cohort 1 Healthy Volunteers Placebo | Placebo comparator | Drug: PlaceboPlacebo to match LEVI-04 single intravenous dose Healthy Volunteers |
| Cohort 2 Healthy Volunteers Placebo | Placebo comparator | Drug: PlaceboPlacebo to match LEVI-04 single intravenous dose Healthy Volunteers |
| Cohort 3 Healthy Volunteers Placebo | Placebo comparator | Drug: PlaceboPlacebo to match LEVI-04 single intravenous dose Healthy Volunteers |
| Cohort 4 Osteoarthritis Patients Placebo | Placebo comparator | Drug: PlaceboPlacebo to match LEVI-04 single intravenous dose Osteoarthritis Patients |
| Cohort 5 Osteoarthritis Patients Placebo | Placebo comparator | Drug: PlaceboPlacebo to match LEVI-04 single intravenous dose Osteoarthritis Patients |
| Cohort 6 Osteoarthritis Patients Placebo | Placebo comparator | Drug: PlaceboPlacebo to match LEVI-04 single intravenous dose Osteoarthritis Patients |
| Cohort 7 Osteoarthritis Patients Placebo | Placebo comparator | Drug: PlaceboPlacebo to match LEVI-04 single intravenous dose Osteoarthritis Patients |
| Cohort 8 Healthy Volunteers Placebo | Placebo comparator | Drug: PlaceboPlacebo to match LEVI-04 single intravenous dose Healthy Volunteers |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Body mass index 18.0-<32.0 kg/m2 (healthy volunteers) and 18.0-<40.0 kg/m2 (osteoarthritis patients)
- Willing and able to give written fully informed consent
- Men with female partners of childbearing potential must agree to follow the requirements for effective contraception throughout the study and for 112 days post-dose
- Women of non childbearing potential
- Healthy volunteers (aged 18 to 65 years) willing to give written consent to have data entered into the Over-volunteering Prevention System
Key exclusion criteria (48 listed)
- Women of childbearing potential, or who are pregnant or lactating
- Clinically relevant abnormal history, physical findings, electrocardiograph, or laboratory values at screening that could interfere with the objectives of the trial or the safety of the subject
- Presence of acute or chronic illness or history of chronic illness (other than osteoarthritis, controlled diabetes, asthma or hypertension for osteoarthritis patients), sufficient to invalidate participation in the trial or make it unnecessarily hazardous
- Impaired endocrine, thyroid, hepatic, respiratory (other than asthma that has been controlled by the use of acceptable medication for at least 3 months prior to screening) or renal function; or history of any psychotic mental illness or clinically significant psychiatric disorder
- History of carpal tunnel syndrome with signs or symptoms within one year before screening or a Boston Carpal Tunnel Questionnaire score >3
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 |
|---|---|---|
| LEVI-04LEVI-04 intravenous infusion | Drug | Cohort 1 Healthy Volunteers Active, Cohort 2 Healthy Volunteers Active, Cohort 3 Healthy Volunteers Active, Cohort 4 Osteoarthritis Patients Active, Cohort 5 Osteoarthritis Patients Active, Cohort 6 Osteoarthritis Patients Active, Cohort 7 Osteoarthritis Patients Active, Cohort 8 Healthy Volunteers Active |
| PlaceboPlacebo intravenous infusion | Drug | Cohort 1 Healthy Volunteers Placebo, Cohort 2 Healthy Volunteers Placebo, Cohort 3 Healthy Volunteers Placebo, Cohort 4 Osteoarthritis Patients Placebo, Cohort 5 Osteoarthritis Patients Placebo, Cohort 6 Osteoarthritis Patients Placebo, Cohort 7 Osteoarthritis Patients Placebo, Cohort 8 Healthy Volunteers Placebo |
Primary outcome
Incidence of treatment emergent adverse events [Safety and tolerability]
Time frame: Change from Baseline at Day 56 post-dose for healthy volunteers and change from Baseline at Day 105 post-dose for osteoarthritis patients
adverse events; laboratory tests; electrocardiograms and injection site reaction assessments
Change from Baseline in neurological assessments [Safety and tolerability] - SAS
Time frame: Change from Baseline at Day 56 post-dose for healthy volunteers and change from Baseline at Day 105 post-dose for osteoarthritis patients
Neurological assessment (Survey of Autonomic Symptoms (SAS) Questionnaire)
Change from Baseline in neurological assessments [Safety and tolerability] - BCTQ
Time frame: Change from Baseline at Day 56 post-dose for healthy volunteers and change from Baseline at Day 105 post-dose for osteoarthritis patients
Neurological assessment (Boston Carpal Tunnel Questionnaire (BCTQ)
Change from Baseline in neurological assessments [Safety and tolerability] - 4th finger test
Time frame: Change from Baseline at Day 56 post-dose for healthy volunteers and change from Baseline at Day 105 post-dose for osteoarthritis patients
Neurological assessment (the carpal tunnel syndrome (CTS) 4th finger neurological test or Total Neuropathy Score nurse)
8 secondary outcomes
Pharmacokinetics of single ascending intravenous doses of LEVI-04 in healthy volunteers and osteoarthritis patients - maximum concentration
Time frame: Up to Day 56 post-dose for healthy volunteers and up to Day 105 post-dose for osteoarthritis patients
Pharmacokinetics of single ascending intravenous doses of LEVI-04 in healthy volunteers and osteoarthritis patients - time to maximum concentration
Time frame: Up to Day 56 post-dose for healthy volunteers and up to Day 105 post-dose for osteoarthritis patients
Pharmacokinetics of single ascending intravenous doses of LEVI-04 in healthy volunteers and osteoarthritis patients - Area Under the Curve
Time frame: Up to Day 56 post-dose for healthy volunteers and up to Day 105 post-dose for osteoarthritis patients
Pharmacokinetics of single ascending intravenous doses of LEVI-04 in healthy volunteers and osteoarthritis patients - half-life
Time frame: Up to Day 56 post-dose for healthy volunteers and up to Day 105 post-dose for osteoarthritis patients
Pharmacokinetics of single ascending intravenous doses of LEVI-04 in healthy volunteers and osteoarthritis patients - clearance
Time frame: Up to Day 56 post-dose for healthy volunteers and up to Day 105 post-dose for osteoarthritis patients
Pharmacokinetics of single ascending intravenous doses of LEVI-04 in healthy volunteers and osteoarthritis patients - elimination rate
Time frame: Up to Day 56 post-dose for healthy volunteers and up to Day 105 post-dose for osteoarthritis patients
Pharmacokinetics of single ascending intravenous doses of LEVI-04 in healthy volunteers and osteoarthritis patients - volume of distribution
Time frame: Up to Day 56 post-dose for healthy volunteers and up to Day 105 post-dose for osteoarthritis patients
To assess the formation of anti-drug antibodies (ADA) to LEVI-04 in healthy volunteers and osteoarthritis patients
Time frame: Up to Day 56 post-dose for healthy volunteers and up to Day 105 post-dose for osteoarthritis patients
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 8 Apr 2021.
- 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.
Denisa Wilkes, MUDr principal investigator
Hammersmith Medicines Research
2 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 LEVI-04 in people with Healthy Volunteers and Osteoarthritis, run by Levicept at 2 sites 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 8 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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] (time frame: Change from Baseline at Day 56 post-dose for healthy volunteers and change from Baseline at Day 105 post-dose for osteoarthritis patients). The study lists 4 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 8 Apr 2021.