NCT05922813

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

A Phase I Clinical Trial to Evaluate the Safety and Tolerability of a Single-dose Administration of BMI2004 Inj. (Hyaluronidase, Recombinant) in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 257 (actual)
• Sponsor: BMI Korea · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Health, Subjective

Interventions

Type	Name	Description
BIOLOGICAL	BMI2004	hyaluronidase, recombinant
OTHER	0.9% NaCl	Normal Saline

Timeline

• Start date: 2022-06-30
• Primary completion: 2023-03-10
• Completion: 2023-04-12
• First posted: 2023-06-28
• Last updated: 2023-06-28

Locations

1 site across 1 country: South Korea