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Safety, Pharmacokinetics, and Pharmacodynamic Testing of Rabies mAb CBB 1

NCT05832073 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2023-04-27

No results posted yet for this study

Summary

rabies mab CBB 1 is mainly used for passive immunization of patients bitten or scratched by rabies or other animals carrying rabies virus, this study mainly studies the safety, tolerability, pharmacokinetics, neutralizing antibody activity and immunogenic characteristics of rabies mAb CBB 1 in healthy adults

Conditions

  • Rabies Virus Infection

Interventions

DRUG

Natural full human monoclonal antibody CBB 1 injection

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

DRUG

Natural full human monoclonal antibody CBB 1 injection placebo

Composition: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection

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

  • 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
2023-04-30
Primary Completion
2023-12-30
Completion
2024-04-30

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 NCT05832073 on ClinicalTrials.gov