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Health, SubjectivePhase 1NCT05922813

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

A Phase 1 study testing BMI2004 and 0.9% NaCl in people with Health, Subjective, run by BMI Korea at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Health, Subjective
What is being tested?
BMI2004 and 0.9% NaCl
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
257 participants
Where
1 siteSouth Korea
Study dates
30 Jun 2022to 12 Apr 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • [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)
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  • 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
  • Subjects who are allergic to the Chinese hamster ovary (CHO) proteins, bee venoms, bee venom acupuncture, bovine proteins, or ovine proteins
  • Subjects who are allergic or hypersensitive to the IPs or its ingredient
  • [Others]
  • Women of child-bearing potential or in the period of less than 12 months after menopause who have been confirmed positive in the pregnancy test (Urine hCG or Serum β hCG) at the screening visit (Visit 1)
  • Breast-feeding women or women who plan to breast-feed during the study
  • Subject who plan to participate in another study or subjects who participated in another study and were administered or treated with an investigational product (or investigational device) within six months before the screening visit (Visit 1)
  • Subjects determined to be ineligible for the study by the investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Chung-Ang University Hospital

    Seoul, Heukseok-ro, Dongjak-gu, 06973

Other trials in South Korea

About this study

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

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

Read the 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.

Being tested
BMI2004, 0.9% NaCl
Keywords
hyaluronidase, hyaluronidase, recombinant, BMI Korea, BMI2004

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMI2004Biological

    Also called hyaluronidase, recombinant

    hyaluronidase, recombinant

  • 0.9% NaClOther

    Normal Saline

Study groups in NCT05922813
Study groupRoleWhat they receive
BMI2004 Inj.Experimentalhyaluronidase, recombinant
Receives: Biological: BMI2004
0.9% NaClPlacebo comparatorNormal Saline
Receives: Other: 0.9% NaCl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: within 48 hours after the intradermal injection of the IPs

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

    Measured: at 30 minutes after the intradermal injection

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

    Measured: at 48 hours after the intradermal injection

Secondary outcomes (4)

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

    Immediate drug allergic reaction is defined as drug allergic reaction with a wheal of ≥8 mm with/without a pseudopod, or an erythema or localized itching at the injection site within 30 minutes after the intradermal injection of the IPs

    Measured: within 30 minutes after the intradermal injection in Part I

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

    Delayed drug allergic reaction is defined as drug allergic reaction occurring between 30 minutes and 48 hours after the intradermal injection of the IPs, including, but not limited to, redness, rash, wheals, edema, erythema, or acute generalized exanthematous pustulosis and erythema multiforme, etc., at the injection site

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

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

    At each time points, wheals, erythema, localized itching and others are collected as adverse events after the administration of the IPs

    Measured: at 30 minutes and 48 hours after the intradermal injection

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

    At each time points, the size of a wheal or erythema is measured. To determine the size of the wheal or erythema, the long diameter and the short diameter orthogonally intersection the long diameter at the center or the long diameter are measured and the mean of the two diameters is calculated for the size of the wheal or erythema.

    Measured: at 30 minutes and 48 hours after the intradermal injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2023
  2. Study start30 Jun 2022
  3. Primary completion10 Mar 2023
  4. Study completion12 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
257 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05922813
Sponsor's protocol ID
BMI2004-SIT-01
Status last verified
Jun 2023
First submitted
13 Jun 2023
Last updated
28 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BMI2004 and 0.9% NaCl in people with Health, Subjective, run by BMI Korea at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part I : Incidence of drug allergic reaction within 48 hours after the intradermal injection of the IPs (time frame: within 48 hours after the intradermal injection of the IPs). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05922813.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.

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