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

Sponsor
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Study ID
NCT07156864
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • 1/10 therapeutic dose — DRUG
    5 volunteers + 1 replacement volunteer will recieve 1/10 therapeutic dose of the study drug (parenteral administration).
  • 1/2 therapeutic dose — DRUG
    5 volunteers + 1 replacement volunteer will recieve 1/2 therapeutic dose of the study drug (parenteral administration).
  • full therapeutic dose — DRUG
    15 volunteers + 3 replacement volunteers will recieve full therapeutic dose of the study drug (parenteral administration).
  • Patients with a verified diagnosis of COVID-19 — DRUG
    10 volunteers with a verified diagnosis of COVID-19 will recieve full therapeutic dose of the study drug (parenteral administration).

Study Details

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.

Key Dates

First listed
Sep 5, 2025
Start date
Sep 30, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
35 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 1/10 therapeutic dose
    5 healthy volunteers + 1 healthy replacement volunteer will recieve 1/10 therapeutic dose of the study drug.
  • Experimental: 1/2 therapeutic dose
    5 healthy volunteers + 1 healthy replacement volunteer will recieve 1/2 therapeutic dose of the study drug.
  • Experimental: full therapeutic dose
    15 healthy volunteers + 3 healthy replacement volunteers will recieve full therapeutic dose of the study drug.
  • Experimental: 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.

Primary Outcome Measure

Occurrence of adverse events (AE) [ Time Frame: within 28 days after administration of the study drug ]

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