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A Phase 1 Study to Assess the Safety of NLY01 in Healthy Subjects

NCT03672604 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2019-09-30

No results posted yet for this study

Summary

This is a Phase 1, first-in-human study designed to assess the safety, tolerability, and pharmacokinetics of NLY01, a PEGylated form of exenatide, in healthy volunteers. NLY01 is being developed as a potential treatment for neurodegenerative disorders including Parkinson's disease. This study is intended to identify the appropriate dose-range for evaluation in Parkinson's disease patients.

Conditions

  • Safety and Tolerability in Healthy Volunteers

Interventions

DRUG

NLY01

NLY01, a PEGylated form of the anti-diabetic peptide exenatide

Sponsors & Collaborators

  • Neuraly, Inc.

    lead INDUSTRY

Principal Investigators

  • Emanuel DeNoia, MD · ICON Early Phase Services/CRU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2018-09-19
Primary Completion
2019-07-30
Completion
2019-07-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03672604 on ClinicalTrials.gov