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"Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Drug B10-FC After Single Administration to Adult Patients".

NCT07156864 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-09-05

No results posted yet for this study

Summary

A two-stage open-label, prospective, safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity study with participation of healthy volunteers in three dose-escalation groups and patients with a confirmed diagnosis of COVID-19.

Conditions

Interventions

DRUG

1/10 therapeutic dose

5 volunteers + 1 replacement volunteer will recieve 1/10 therapeutic dose of the study drug (parenteral administration).

DRUG

1/2 therapeutic dose

5 volunteers + 1 replacement volunteer will recieve 1/2 therapeutic dose of the study drug (parenteral administration).

DRUG

full therapeutic dose

15 volunteers + 3 replacement volunteers will recieve full therapeutic dose of the study drug (parenteral administration).

DRUG

Patients with a verified diagnosis of COVID-19

10 volunteers with a verified diagnosis of COVID-19 will recieve full therapeutic dose of the study drug (parenteral administration).

Sponsors & Collaborators

  • Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2025-12-31
Completion
2025-12-31

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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 NCT07156864 on ClinicalTrials.gov