"Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Drug B10-FC After Single Administration to Adult Patients".
Not Applicable
Not yet recruiting
- Conditions
- COVID-19
- Interventions
- Drug: 1/10 therapeutic doseDrug: 1/2 therapeutic doseDrug: Patients with a verified diagnosis of COVID-19Drug: full therapeutic dose
- Registration Number
- NCT07156864
- Lead Sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description 1/10 therapeutic dose 1/10 therapeutic dose 5 healthy volunteers + 1 healthy replacement volunteer will recieve 1/10 therapeutic dose of the study drug. 1/2 therapeutic dose 1/2 therapeutic dose 5 healthy volunteers + 1 healthy replacement volunteer will recieve 1/2 therapeutic dose of the study drug. full therapeutic dose Patients with a verified diagnosis of COVID-19 15 healthy volunteers + 3 healthy replacement volunteers will recieve full therapeutic dose of the study drug. Patients with a verified diagnosis of COVID-19 full therapeutic dose 10 volunteers with a verified diagnosis of COVID-19 will recieve full therapeutic dose of the study drug.
- Primary Outcome Measures
Name Time Method Occurrence of adverse events (AE) within 28 days after administration of the study drug
- Secondary Outcome Measures
Name Time Method