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

NCT05922813 | Completed Phase 1 DMC

• 1 other identifier: BMI2004-SIT-01
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hyaluronidase; hyaluronidase, recombinant; BMI Korea; BMI2004

Outcome Measures

Primary Outcomes (3)

• Part I : Incidence of drug allergic reaction within 48 hours after the intradermal injection of the IPs

  Drug allergic reactions include both immediate allergic reaction (within 30 minutes after IPs administration) and delayed drug allergic reaction (between 30 minutes and 48 hours after IPs administration).

  within 48 hours after the intradermal injection of the IPs

• Part II : Incidence of adverse events after the subcutaneous injection of the IPs

  at 30 minutes after the intradermal injection

• Part II : Incidence of adverse events after the subcutaneous injection of the IPs

  at 48 hours after the intradermal injection

Secondary Outcomes (4)

• Incidence of immediate drug allergic reaction within 30 minutes after the intradermal injection of the IPs

  within 30 minutes after the intradermal injection in Part I

• Incidence of delayed drug allergic reaction at 30 minutes and 48 hours after the intradermal injection of the IPs

  between 30 minutes and 48 hours after the intradermal injection in Part I

• Incidence of injection site reaction at 30 minutes and 48 hours after the administration of the IPs

  at 30 minutes and 48 hours after the intradermal injection

• Size of the wheal or erythema at 30 minutes and 48 hours after the administration of the IPs

  at 30 minutes and 48 hours after the intradermal injection

Study Arms (2)

BMI2004 Inj.

EXPERIMENTAL

hyaluronidase, recombinant

Biological: BMI2004

0.9% NaCl

PLACEBO COMPARATOR

Normal Saline

Other: 0.9% NaCl

Interventions

BMI2004 BIOLOGICAL

hyaluronidase, recombinant

Also known as: hyaluronidase, recombinant

BMI2004 Inj.

0.9% NaCl OTHER

Normal Saline

0.9% NaCl

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female aged 19 years or above at the screening visit(Visit 1)
• Female subject who are non-childbearing potential due to menopause or surgery or who have agreed to use methods of contraception during the study, or male subjects with female partners who meet the aforementioned conditions, including º Female subjects who are post-menopausal (Diagnosed with nontherapy-induced amenorrhea or menopause for 12 months or longer) or male subjects with female partners who meet the said conditions º Female subjects who are of non-childbearing potential due to surgery (oophorectomy and/or hysterectomy) or male subjects with female partners who meet the said conditions º Subjects who have agreed to observe absolute sexual abstinence during the study \[except for the case of partial sexual abstinence of female subjects (e.g., coitus interruptus in the ovulation or post-ovulation period or the basal body temperature)\] º Subjects who have agreed to use the following methods of contraception, if female subjects or female partners of male subjects are women of child-bearing potential (WOCBP) and did not undergo infertility surgery
• \- Hormonal contraceptives (implantable form, patch or oral administration)
• Intrauterine devices(IUD)
• Double-barrier methods\*(Simultaneous use of two of the following methods: Male condoms, female condoms, cervical caps, contraceptive diaphragms, contraceptive sponge, and spermicides) \*Simultaneous use of male condoms and female condoms is not considered to be a double barrier method.
• Subjects with no tattoos, acne, dermatitis, pigmentation, scars, lesions, or damaged skin on the injection site for the investigational products (IPs) to be administered and for the allergen test to be conducted
• Subjects who have decided to voluntarily participate in the study and provided a written consent regarding observance of precautions after having been informed of and having fully understood the objectives, methods, and effects of the study in detail
• Subject with a Body Mass Index (BMI)\* between 18.5 and 30.0 kg/㎡
• BMI = Weight(kg) / Height (m)²

You may not qualify if:

• \[Medication History\]
• Subjects who were administered or treated with the following medications during the periods mentioned below from the screening visit (Visit 1) or are scheduled for administration during the study º Within one month prior to the screening visit: Hyaluronidase, Chemotherapeutic agent, Immunosuppressive agent º Within 14 days prior to the screening visit: Glucocorticoid (e.g., Dexamethasone, Prednisone, etc.), Antihistamine (e.g., Chlopheniramine, Hydroxyzine, Ketotifen, etc.) Non-steroidal anti-inflammatory drugs(NSAIDs)(e.g., Aspirin, Aceclofenac, etc.), Penicillin (e.g., Amoxicillin, Ampicillin, etc.), Cephalosporins(e.g., Cefaclor, Cefadroxil, Cefixime, etc.), Sulfa antibiotics (e.g., Sulfadiazine, Sulfamethoxazole, etc.) and Quinolones (e.g., Ciprofloxacin, Levofloxacin, etc.)
• \[Medical History and Concurrent Disease\]
• Subjects with a history of anaphylaxis
• Subjects who had an acute fever with a temperature over 37.5℃ within seven days before the expected date of administration of the IPs or had a symptom from which an acute disease is inferred within 14 days before the expected date of administration
• Subjects with a history of drug abuse or alcoholism or subjects who are suspected of drug abuse or alcoholism before the screening visit(Visit 1)
• Subjects with a systolic blood pressure(SBP) \> 140 mmHg or \< 80 mmhg or a diastolic blood pressure (DBP) \> 90 mmHg or \< 50 mmHg by the vital sign tests at the screening visit (Visit 1)
• Subjects with clinically significant abnormal results by the laboratory tests, physical examinations, vital sign tests, or electrocardiography at the screening visit (Visit 1)
• Subjects with a total protein of 5.5 g/dL or less by the blood chemistry tests at the screening visit (Visit 1)
• Subjects determined by the investigator to be ineligible for the study due to the following serious medical or psychiatric disorders
• ① Cardiac disease : Myocardial infarction, coronary artery bypass, arrhythmia or other serious cardiac diseases, venous stasis, etc.
• ② History of malignant tumors within five years before the screening visit (Visit 1)
• ③ Immunological disorders that may affect the immunological system \[e.g., Rheumatoid arthritis, Human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C Virus (HCV), etc.\]
• ④ Mental illness such as alcoholism
• ⑤ Disorders in the respiratory, hepato-biliary, nervous, endocrine, genitourinary, and musculoskeletal systems determined to be clinically significant by the investigator

Sponsors & Collaborators

• BMI Korea: lead

Study Sites (1)

Chung-Ang University Hospital

Seoul, Heukseok-ro, Dongjak-gu, 06973, South Korea

Location

MeSH Terms

Interventions

Hyaluronoglucosaminidase; Saline Solution

Intervention Hierarchy (Ancestors)

Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Beom Joon Kim, MD, Ph.D.

  Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 28, 2023
• Study Start: June 30, 2022
• Primary Completion: March 10, 2023
• Study Completion: April 12, 2023
• Last Updated: June 28, 2023

Record last verified: 2023-06

Locations

KR (1)