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A Study of the Tolerance, Safety, and Pharmacokinetics of GNR-055 in Healthy Volunteers

NCT06475404 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-07-03

No results posted yet for this study

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

Interventions

BIOLOGICAL

verenafusp alfa 6 mg/kg

Single intravenous administration of 6 mg/kg of verenafusp alfa

BIOLOGICAL

verenafusp alfa 9 mg/kg

Single intravenous administration of 9 mg/kg of verenafusp alfa

BIOLOGICAL

verenafusp alfa 12 mg/kg

Single intravenous administration of 12 mg/kg of verenafusp alfa

Sponsors & Collaborators

  • AO GENERIUM

    lead INDUSTRY

Principal Investigators

  • Oksana A. Markova, MD · JSC GENERIUM

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-06
Primary Completion
2023-09-20
Completion
2023-09-20

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 NCT06475404 on ClinicalTrials.gov