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Safety and Pharmacokinetics of GNR-038 in Healthy Volunteers

NCT04557319 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-09-30

No results posted yet for this study

Summary

It is an open-label dose-escalating study in sequential cohorts to assess safety and pharmacokinetics of GNR-038.

Conditions

Interventions

BIOLOGICAL

GNR-038, 25 МЕ/kg

25 МЕ/kg once per study

BIOLOGICAL

GNR-038, 50 МЕ/kg

50 МЕ/kg once per study

BIOLOGICAL

GNR-038, 100 МЕ/kg

100 МЕ/kg once per study

Sponsors & Collaborators

  • AO GENERIUM

    lead INDUSTRY

Principal Investigators

  • Oksana A. Markova, MD · AO GENERIUM

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Months
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-10
Primary Completion
2020-08-27
Completion
2020-08-27

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

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 NCT04557319 on ClinicalTrials.gov