Parkinson DiseasePhase 1NCT05790382
Single and Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of NM-101
A Phase 1 study testing NM-101 in people with Parkinson Disease, run by Neuramedy Co. Ltd. at 1 site in United Kingdom.
Trial summary
This is a Phase I, double-blind, randomised, two-part, single-ascending dose (Part 1) and multiple-ascending dose (Part 2) study of NM-101 in healthy males and healthy females of non-childbearing potential Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- NM-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 May 2023to 14 Jun 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed Consent and Compliance
- Must provide written informed consent
- Must be willing and able to communicate and participate in the whole study
- Demographics and Contraception
- Aged 18 to 65 years inclusive at the time of signing informed consent
- Must agree to adhere to the contraception requirements
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- Baseline Characteristics
- Healthy males or WONCBP
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
- Other
- Must have received at least 2 doses of a COVID-19 vaccine
Who cannot join
- Medical/Surgical History and Mental Health
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- History of allergic or anaphylactic reactions to humanised or other therapeutic monoclonal antibodies or to any of the excipients of NM-101
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
- Undergone a lumbar puncture within 6 weeks before Day 1 (Part 2 only)
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- Medical history or evidence of mass occupying lesion in brain or spinal cord or history of spinal cord injury, which could preclude the procedure of lumbar puncture and CSF collection (Part 2 only)
- Evidence or history of clinically significant back pain, back pathology and/or back injury (e.g. degenerative disease, spinal deformity or spinal surgery) that may predispose to complications or technical difficulties in the conduct of a lumbar puncture (Part 2 only)
- Physical Examination
- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
- Diagnostic Assessments
- Evidence of current SARS-CoV-2 infection
- History of an infection requiring treatment within 14 days of first dose of the IMP
- A history of any ongoing, chronic or recurrent infectious disease, herpes, or evidence of tuberculosis infection as defined by a positive QuantiFERON® TB Gold test at screening
- Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results
- Females of childbearing potential including those who are pregnant or lactating (all female subjects must have a negative highly sensitive serum pregnancy test)
- Prior Study Participation
- Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer
- Subjects who have previously been administered IMP in this study. Subjects who have taken part in Part 1 are not permitted to take part in Part 2 and vice versa
- Subjects who report to have previously received NM-101 (formerly known as OPN-305)
- Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
- Prior and Concomitant Medication
- Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day or HRT) in the 14 days before first IMP administration. Exceptions may apply, as determined by the investigator
- Subjects who have had a vaccine (including COVID-19 vaccine) within 28 days before first dose
- Have taken non-steroidal anti-inflammatory drugs or other drugs that affect coagulation or platelet function within 14 days prior to scheduled lumbar puncture (Part 2 only)
- Lifestyle Characteristics
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males >21 units per week and in females >14 units per week
- A confirmed positive alcohol breath test at screening or admission
- Current smokers and those who have smoked within the last 12 months
- A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- Confirmed positive drugs of abuse test result
- Other
- Male subjects with pregnant or lactating partners
- Travelled to an area where there is risk of malaria within the past year unless adequate precautions were taken
- Subjects who are, or are immediate family members of, a study site or sponsor employee
- Failure to satisfy the investigator of fitness to participate for any other reason
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Sciences
Nottingham
Stuart Mair, MBChB, DRCOG, +44 (o)115 974 9000, Stuart.Mair@quotientsciences.com
About this study
Official title: A Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of NM-101 in Healthy Male and Female Subjects
This is a Phase I, double-blind, randomised, two-part, single-ascending dose (Part 1) and multiple-ascending dose (Part 2) study of NM-101 in healthy males and healthy females of non-childbearing potential
Read the detailed description
NM-101 is an anti-TLR2 antibody which may have clinical efficacy in Parkinson's disease patients. This Phase I study aims to assess the safety, tolerability and pharmacokinetics (PK) of single and multiple ascending doses of NM-101 in healthy males and healthy females of non-childbearing potential. A total of 56 subjects (8 per cohort) are planned to be enrolled.
Subjects will be randomly assigned to recieve NM-101 or placebo in a 3:1 ratio. The study will be in 2 parts: Part 1 will consist of 3 single-dose cohorts; Part 2 will consist of 4 multiple-dose cohorts.
In Part 1, sentinel dosing will be applied. In each cohort, 1 subject will be randomised to receive NM-101 and 1 subject will be randomised to receive placebo ahead of dosing in the remaining 6 subjects. The dose for Cohort 1 is 20 mg/kg NN-101. The predicted doses for Cohorts 2 and 3 are 40 mg/kg and 60 mg/kg NM-101, respectively (dependent on a blinded interim review of the safety, tolerability and PK data). Blood samples will be collected at regular intervals for PK analysis and safety from Day 1 until Day 42.
In Part 2, sentinel dosing will not be applied. Each subject will receive 4 doses of NM-101 or placebo over the course of 3 months. Dosing may occur in parallel to the conduct of Part 1. The doses administered will be selected based on emerging safety, tolerability and PK data from preceding groups in Part 1. The predicted NM-101 doses are: 10 mg/kg for Cohort 4; 20 mg/kg for Cohort 5; 40 mg/kg for Cohort 6; 60 mg/kg for Cohort 7. In Cohorts 5 to 7, subjects will undergo a lumbar puncture to assess NM-101 concentrations in the cerebrospinal fluid. Blood samples will be collected at regular intervals for PK analysis and safety from Day 1 until Day 127.
- Conditions
- Parkinson Disease
- Being tested
- NM-101, Placebo
- Keywords
- NM-101, Anti-TLR2 antibody, Blood-brain barrier, Ascending dose
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NM-101Drug
Also called Tomarilimab, OPN-305 (formerly)
In Part 1, each cohort will receive a single dose at one of three dose levels (3 cohorts).
In Part 2, each cohort will receive multiple doses at one of four dose levels (4 cohorts).
PlaceboDrug
Placebo solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| NM-101 | Experimental | Ascending doses of NM-101. IV infusion over 2 hours Receives: Drug: NM-101 |
| Placebo | Placebo comparator | IV infusion over 2 hours Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of NM-101: Incidence of Treatment-Related Adverse Events by Severity
A treatment related adverse event is defined as a clinical event with plausible time relationship to NM-101 administration and that cannot be explained by concurrent disease or other drugs or chemicals
Measured: up to 4 months
PK Parameter
maximum concentration (Cmax)
Measured: up to 4 months
PK Parameter
time of the maximum measured concentration (Tmax)
Measured: up to 4 months
PK Parameter
area under the concentration-time curve from time (AUC)
Measured: up to 4 months
PK Parameter
First order rate constant associated with the terminal portion of the curve (Lambda-z)
Measured: up to 4 months
PK Parameter
terminal elimination half life (t1/2)
Measured: up to 4 months
PK Parameter
clearance (CL)
Measured: up to 4 months
PK Parameter
Volume of distribution based on the terminal phase (Vz)
Measured: up to 4 months
PK Parameter
Volume of distribution at steady state (Vss)
Measured: up to 4 months
Secondary outcomes (2)
Cerebrospinal Fluid (CSF) Concentrations of NM-101
Quantification of NM-101 24 h after the dose only in Cohorts 5 to 7
Measured: Day 2 or Day 86
Immunogenicity of NM-101
Quantification of NM-101 anti-drug antibodies pre-dose and after each dose of NM 101
Quantification of NM-101 anti-drug antibodies pre-dose and after each dose of NM 101 Quantification of NM-101 anti-drug antibodies pre-dose and after each dose of NM 101
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start10 May 2023 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion14 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Model description
- 56
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuramedy Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
- Investigators
- Stuart Mair, MBChB, etc., Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790382
- Sponsor's protocol ID
- NM-101-01-2022
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2023
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of NM-101 in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT05790382
- Acronym / sponsor ID
- NM-101-01-2022
- Conditions
- Parkinson Disease
- Keywords
- NM-101, Anti-TLR2 antibody, Blood-brain barrier, Ascending dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Neuramedy Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 10 May 2023 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 14 Jun 2024 (estimated)
- First posted
- 30 Mar 2023 (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 Phase I, double-blind, randomised, two-part, single-ascending dose (Part 1) and multiple-ascending dose (Part 2) study of NM-101 in healthy males and healthy females of non-childbearing potential
Detailed description
NM-101 is an anti-TLR2 antibody which may have clinical efficacy in Parkinson's disease patients. This Phase I study aims to assess the safety, tolerability and pharmacokinetics (PK) of single and multiple ascending doses of NM-101 in healthy males and healthy females of non-childbearing potential. A total of 56 subjects (8 per cohort) are planned to be enrolled.
Subjects will be randomly assigned to recieve NM-101 or placebo in a 3:1 ratio. The study will be in 2 parts: Part 1 will consist of 3 single-dose cohorts; Part 2 will consist of 4 multiple-dose cohorts.
In Part 1, sentinel dosing will be applied. In each cohort, 1 subject will be randomised to receive NM-101 and 1 subject will be randomised to receive placebo ahead of dosing in the remaining 6 subjects. The dose for Cohort 1 is 20 mg/kg NN-101. The predicted doses for Cohorts 2 and 3 are 40 mg/kg and 60 mg/kg NM-101, respectively (dependent on a blinded interim review of the safety, tolerability and PK data). Blood samples will be collected at regular intervals for PK analysis and safety from Day 1 until Day 42.
In Part 2, sentinel dosing will not be applied. Each subject will receive 4 doses of NM-101 or placebo over the course of 3 months. Dosing may occur in parallel to the conduct of Part 1. The doses administered will be selected based on emerging safety, tolerability and PK data from preceding groups in Part 1. The predicted NM-101 doses are: 10 mg/kg for Cohort 4; 20 mg/kg for Cohort 5; 40 mg/kg for Cohort 6; 60 mg/kg for Cohort 7. In Cohorts 5 to 7, subjects will undergo a lumbar puncture to assess NM-101 concentrations in the cerebrospinal fluid. Blood samples will be collected at regular intervals for PK analysis and safety from Day 1 until Day 127.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 56
| Arm | Type | Receives |
|---|---|---|
| NM-101 | Experimental | Drug: NM-101Ascending doses of NM-101. IV infusion over 2 hours |
| Placebo | Placebo comparator | Drug: PlaceboIV infusion over 2 hours |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Informed Consent and Compliance
- Must provide written informed consent
- Must be willing and able to communicate and participate in the whole study
- Demographics and Contraception
- Aged 18 to 65 years inclusive at the time of signing informed consent
Key exclusion criteria (39 listed)
- Medical/Surgical History and Mental Health
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- History of allergic or anaphylactic reactions to humanised or other therapeutic monoclonal antibodies or to any of the excipients of NM-101
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
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 |
|---|---|---|
| NM-101Also: Tomarilimab, OPN-305 (formerly)In Part 1, each cohort will receive a single dose at one of three dose levels (3 cohorts). In Part 2, each cohort will receive multiple doses at one of four dose levels (4 cohorts). | Drug | NM-101 |
| PlaceboPlacebo solution for infusion | Drug | Placebo |
Primary outcome
Safety of NM-101: Incidence of Treatment-Related Adverse Events by Severity
Time frame: up to 4 months
A treatment related adverse event is defined as a clinical event with plausible time relationship to NM-101 administration and that cannot be explained by concurrent disease or other drugs or chemicals
PK Parameter
Time frame: up to 4 months
maximum concentration (Cmax)
PK Parameter
Time frame: up to 4 months
time of the maximum measured concentration (Tmax)
PK Parameter
Time frame: up to 4 months
area under the concentration-time curve from time (AUC)
PK Parameter
Time frame: up to 4 months
First order rate constant associated with the terminal portion of the curve (Lambda-z)
PK Parameter
Time frame: up to 4 months
terminal elimination half life (t1/2)
PK Parameter
Time frame: up to 4 months
clearance (CL)
PK Parameter
Time frame: up to 4 months
Volume of distribution based on the terminal phase (Vz)
PK Parameter
Time frame: up to 4 months
Volume of distribution at steady state (Vss)
2 secondary outcomes
Cerebrospinal Fluid (CSF) Concentrations of NM-101
Time frame: Day 2 or Day 86
Immunogenicity of NM-101
Time frame: up to 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- 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.
Stuart Mair, MBChB, etc. principal investigator
Quotient Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NM-101 in people with Parkinson Disease, run by Neuramedy Co. Ltd. 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 11 inclusion and 39 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: status not confirmed, as of the sponsor's last update on 30 Mar 2023. 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?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of NM-101: Incidence of Treatment-Related Adverse Events by Severity (time frame: up to 4 months). 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 30 Mar 2023.