Single and Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of NM-101

NCT05790382 | Unknown Phase 1

• 1 other identifier: NM-101-01-2022
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Parkinson Disease

Keywords

NM-101; Anti-TLR2 antibody; Blood-brain barrier; Ascending dose

Outcome Measures

Primary Outcomes (9)

• 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

  up to 4 months

• PK Parameter

  maximum concentration (Cmax)

  up to 4 months

• PK Parameter

  time of the maximum measured concentration (Tmax)

  up to 4 months

• PK Parameter

  area under the concentration-time curve from time (AUC)

  up to 4 months

• PK Parameter

  First order rate constant associated with the terminal portion of the curve (Lambda-z)

  up to 4 months

• PK Parameter

  terminal elimination half life (t1/2)

  up to 4 months

• PK Parameter

  clearance (CL)

  up to 4 months

• PK Parameter

  Volume of distribution based on the terminal phase (Vz)

  up to 4 months

• PK Parameter

  Volume of distribution at steady state (Vss)

  up to 4 months

Secondary Outcomes (2)

• Cerebrospinal Fluid (CSF) Concentrations of NM-101

  Day 2 or Day 86

• Immunogenicity of NM-101

  up to 4 months

Study Arms (2)

NM-101

EXPERIMENTAL

Ascending doses of NM-101. IV infusion over 2 hours

Drug: NM-101

Placebo

PLACEBO COMPARATOR

IV infusion over 2 hours

Drug: Placebo

Interventions

NM-101 DRUG

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).

Also known as: Tomarilimab, OPN-305 (formerly)

NM-101

Placebo DRUG

Placebo solution for infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Neuramedy Co. Ltd.: lead
• Quotient Sciences: collaborator

Study Sites (1)

Quotient Sciences

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

tomaralimab; rhoA GTP-Binding Protein

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

rho GTP-Binding Proteins; Monomeric GTP-Binding Proteins; GTP-Binding Proteins; GTP Phosphohydrolases; Acid Anhydride Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Intracellular Signaling Peptides and Proteins

Study Officials

• Stuart Mair, MBChB, etc.

  Quotient Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study. Prior to dosing visit 4 for Cohort 2, a small team will be unblinded to treatment assignment in order to conduct lumbar punctures on subjects assigned to active IMP only
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 56

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 30, 2023
• Study Start: May 10, 2023
• Primary Completion: May 30, 2024
• Study Completion: June 14, 2024
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)