A Multi-cohort Study of the Tolerance, Safety, and Pharmacokinetics of GNR-055 in Healthy Volunteers
NCT04539340 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2020-10-14
Summary
It is a phase I open-label single-dose, dose-escalation cohort study to evaluate of the tolerance, safety, and pharmacokinetics of GNR-055 in healthy volunteers
Conditions
- Mucopolysaccharidosis Type II
- Metabolic Diseases
Interventions
- BIOLOGICAL
-
GNR-055
Single intravenous administration
Sponsors & Collaborators
-
AO GENERIUM
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-02-28
- Primary Completion
- 2020-09-08
- Completion
- 2020-09-08
Countries
- Russia
Study Locations
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