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

NCT05790382 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-03-30

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Quotient Sciences

    collaborator INDUSTRY

  • Neuramedy Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Stuart Mair, MBChB, etc. · Quotient Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-10
Primary Completion
2024-05-30
Completion
2024-06-14

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05790382 on ClinicalTrials.gov