Single and Multiple Ascending Dose Study to Assess Safety, Tolerability and PK of NM-101
Research type
Research Study
Full 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
IRAS ID
1006899
Contact name
Emma Bain
Contact email
Sponsor organisation
Neuramedy Co. Ltd
Eudract number
2022-003665-37
Clinicaltrials.gov Identifier
NCT05790382.
Research summary
The Sponsor is developing a new test medicine, NM-101 (tomaralimab), for the treatment of Parkinson’s Disease and inflammatory and autoimmune conditions.
This two-part healthy volunteer study will try to explore the safety and tolerability of the test medicine and how it is taken up by the body.
This study will take place at a single non-NHS site, enrolling up to 56 male and female (not of childbearing potential) volunteers aged between 18 and 65 years old.
In Part 1, up to 24 volunteers will be split into 3 groups and will receive a single intravenous (IV) dose of the test medicine or placebo in the fed state. Volunteers will be discharged on Day 4 and will come back to the clinic for return visits on Days 7, 14, 21, 28, 35 and 42, as well as receive a follow-up phone call 3 to 5 days post final return visit.
In Part 2, up to 32 volunteers will be split into 4 groups and will receive up to a total of 4 IV doses of the test medicine or placebo, given once every 28 days in the fed state across 4 dosing visits. Volunteers will be discharged on Days 4, 30, 58 and 88. Volunteers will return to the clinic for return visits on Days 92, 99, 106, 113, 120 and 127 and receive a follow-up phone call 3 to 5 days post final return visit.
Volunteer’s blood and urine will be taken throughout the study for analysis of the test medicine and for their safety. In Part 2, volunteers who receive the test medicine will have a lumbar puncture (a very small volume of spinal fluid will be taken) on Day 2 or Day 86 to see how much of the test medicine is in the fluid. Volunteers who receive placebo will have a stimulated lumbar puncture so that they will not know if they have received the test medicine or placebo.
Volunteers are expected to be involved in this study for approximately 10.5 weeks from screening to the follow up call in Part 1, and approximately 23 weeks from screening to the follow up call in Part 2.
REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0130
Date of REC Opinion
10 Nov 2023
REC opinion
Further Information Unfavourable Opinion