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Intranasal Human FGF-1 for Subjects With Parkinson's Disease

NCT05493462 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2022-08-09

No results posted yet for this study

Summary

This is an open-label, pilot study to evaluate the safety, tolerability and efficacy of two dose levels of human FGF-1 administered intranasally to subjects with Parkinson's disease. A low dose of 450 µg FGF-1 (6 µg/kg for a 75 kg subject) and a high dose of 900 µg FGF-1 (12 µg/kg for a 75 kg subject) will be studied sequentially.

Conditions

  • Parkinson Disease

Interventions

DRUG

Human FGF-1

Intranasal administration of human FGF-1

Sponsors & Collaborators

  • Zhittya Genesis Medicine, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • The Bahamas

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 NCT05493462 on ClinicalTrials.gov