Evaluate the Safety & Tolerability of a Single-dose Administration of

Status Completed

Clinical Trial 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

Clinical Trial Description

This study is a phase I clinical trial to evaluate the drug allergic reaction occurring after the single-dose intradermal injection of BMI2004 Inj. and the safety and tolerability after the single-dose subcutaneous injection of BMI2004 in healthy adults. The study consists of Part I and Part II that Part I is the drug allergic reaction evaluation and Part II is the safety evaluation. Part I (Drug allergic reaction evaluation) : Subjects who provide a written consent to participation in the study will receive the screening test. The subjects determined to be eligible for the study based on the screening test results and inclusion/exclusion criteria are intradermally administered the single-dose test drug (BMI2004 inj.) on the forearm and the single-dose placebo (Dai Han Isotonic Sodium Chloride Inj.) on one the other forearm, respectively, at the baseline visit(Visit 2). Then subjects are investigated for immediate drug allergic reaction occurring within 30 minutes after the administration of the Investigational Products(IPs) and delayed drug allergic reaction occurring between 30 minutes and 48 hours after the administration Part II (safety evaluation) : Subjects confirmed negative in the drug allergic reaction test at Visit 4 on Part I are randomized either to the single-dose test group (BMI2004 Inj.) or the single-dose placebo group (Dai han Isotonic Sodium Chloride Inj.) at a ratio or 2:1 and subcutaneously administered on the right or left arm. After the administration of the IPs, the injection site will be monitored. Subjects with no adverse events within 30 minutes after administration may leave while those with adverse events will receive appropriate treatment before leaving. At the follow-up visit(Visit 6 to 8) and the end-of study(EOS) visit (Visit 9), investigation of changes of concomitant medications, safety evaluation, and scheduled assessments are performed. ;

Study Design

Related Conditions & MeSH terms

Health, Subjective

Clinical Trial Details

NCT number	NCT05922813
Study type	Interventional
Source	BMI Korea
Contact
Status	Completed
Phase	Phase 1
Start date	June 30, 2022
Completion date	April 12, 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms