Rabies mAb CBB 1 Combination Vaccine in Healthy People With Antibody Neutralization Activity and Safety Phase Clinical Trials
NCT06548139 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2024-08-12
Summary
To evaluate the antibody neutralization activity and safety of rabies mAb CBB 1 combination vaccine used in healthy people
Conditions
- Rabies Virus Infection
Interventions
- DRUG
-
Natural full human monoclonal antibody CBB 1 injection 50.0µg/kg
Active ingredient: natural full human monoclonal antibody CBB 1 containing 0.5 mg / ml per dose (2.5ml) Ingredients: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection
- DRUG
-
Natural full human monoclonal antibody CBB 1 injection 100.0µg/kg
Active ingredient: natural full human monoclonal antibody CBB 1 containing 0.5 mg / ml per dose (2.5ml) Ingredients: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection
- DRUG
-
Rabies Human Immunoglobulin (HRIG)
Active ingredient: Rabid human immunoglobulin
- BIOLOGICAL
-
Lyophilized rabies vaccine for human use (Vero cells)
Active ingredient: inactivated rabies virus fixed poison
Sponsors & Collaborators
-
The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
collaborator UNKNOWN -
Anning City First People's Hospital
collaborator UNKNOWN -
Yunnan Central Hospital
collaborator UNKNOWN -
Beijing Contreke Statistical Technology Co., LTD
collaborator UNKNOWN -
Military Science Zhengyuan (Beijing) Pharmaceutical Research Co., LTD
collaborator UNKNOWN -
Changchun BCHT Biotechnology Co.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-07-31
- Primary Completion
- 2025-05-31
- Completion
- 2025-05-31
Countries
- China
Study Locations
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