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Evaluate the Safety and Tolerability of a Single-dose Administration of BMI2004 Inj.

NCT05922813 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2023-06-28

No results posted yet for this study

Summary

A phase I clinical trial to evaluate the safety and tolerability of a single-dose administration of BMI2004 Inj. (hyaluronidase, recombinant) in healthy adults

Conditions

  • Health, Subjective

Interventions

BIOLOGICAL

BMI2004

hyaluronidase, recombinant

OTHER

0.9% NaCl

Normal Saline

Sponsors & Collaborators

  • BMI Korea

    lead INDUSTRY

Principal Investigators

  • Beom Joon Kim, MD, Ph.D. · Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2023-03-10
Completion
2023-04-12

Countries

  • South Korea

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 NCT05922813 on ClinicalTrials.gov