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

No results posted yet for this study

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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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 NCT06548139 on ClinicalTrials.gov