NCT05790382

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Neuramedy Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

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

Interventions

Type	Name	Description
DRUG	NM-101	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	Placebo	Placebo solution for infusion

Timeline

• Start date: 2023-05-10
• Primary completion: 2024-05-30
• Completion: 2024-06-14
• First posted: 2023-03-30
• Last updated: 2023-03-30

Locations

1 site across 1 country: United Kingdom