A Study to Evaluate the Safety, PK, and Immunogenicity of Recombinant Human Hyaluronidase in Healthy Subjects

Официальное название

A Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of Recombinant Human Hyaluronidase in Healthy Chinese Adult Male Subjects

Обзор

The study is being conducted to evaluate the safety, pharmacokinetics, and immunogenicity of recombinant human hyaluronidase in healthy Chinese adult male subjects.

Вмешательства

• Препарат recombinant human hyaluronidase
  HLXTE-HAase02 is a proprietary recombinant human hyaluronidase, with a molecular weight of approximately 49 kDa, is expressed in Chinese Hamster Ovary (CHO) cells and is intended for formulation development.

Первичные конечные точки

• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: From enrollment to 21 days after the second dose]
• Incidence of hypersensitivity reactions [Срок оценки: From enrollment to 21 days after the second dose]
• Incidence of injection site reactions (ISRs) [Срок оценки: From enrollment to 21 days after the second dose]

Вторичные конечные точки (10)

• Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-inf) [Срок оценки: From enrollment to 21 days after the second dose]
• Area under the concentration-time curve from time zero to to the last measurable concentration (AUC0-t) [Срок оценки: From enrollment to 21 days after the second dose]
• Maximum serum concentration (Cmax) [Срок оценки: From enrollment to 21 days after the second dose]
• Time to maximum serum concentration (Tmax) [Срок оценки: From enrollment to 21 days after the second dose]
• Terminal elimination half-life (T1/2) [Срок оценки: From enrollment to 21 days after the second dose]
• Terminal elimination rate constant (λz) [Срок оценки: From enrollment to 21 days after the second dose]
• Extrapolation percentage of AUC (%AUCex) [Срок оценки: From enrollment to 21 days after the second dose]
• Positive rates of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) [Срок оценки: From enrollment to 21 days after the second dose]
• Subcutaneous injection rate (mL/min) [Срок оценки: From enrollment to 21 days after the second dose]
• Mean of triplicate abdominal circumference measurements [Срок оценки: From enrollment to 21 days after the second dose]

Критерии участия

Критерии включения

• Healthy male subjects, aged ≥ 18 and ≤ 45 years.
• Body Mass Index (BMI) ≥ 18.0 and ≤ 28.0 kg/m².
• Intact skin at the injection site, with no damage, tattoos, or other markings.
• No significant medical history, or a history of abnormalities that, in the investigator's judgment, will not impact the study.
• Physical examination, vital signs, electrocardiogram (ECG), chest X-ray, and clinical laboratory tests are normal or abnormal without clinical significance (NCS).
• Subjects must agree to use highly effective contraception with their spouse or partner from the time of signing the Informed Consent Form (ICF) until 3 months after the last dose, or the subject is not capable of reproduction. Subjects must also refrain from sperm donation during the study and for 3 months following the last dose of the investigational product.
• Voluntarily signed the Informed Consent Form (ICF) prior to any study procedures, with a full understanding of the study content, procedures, and potential adverse events (AEs); and the ability to comply with the protocol requirements to complete the study.

Критерии исключения

• History of drug abuse or or substance use, or a positive drug screen; history of long-term heavy alcohol consumption (defined as consuming more than 14 units of alcohol per week within 3 months prior to screening \[1 unit = 360 mL of beer, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine\]) or a positive blood alcohol test; history of long-term heavy alcohol use or positive blood alcohol test; history of long-term heavy smoking (defined as an average of more than 5 cigarettes per day within 3 months prior to screening, or inability to abstain from smoking during the ).
• Cardiac disorders, including but not limited to clinically significant ECG abnormalities during the screening period, QTcF > 450ms, or a history of clinically significant ECG abnormalities.
• History of any clinically severe hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or oncological diseases, or allergic diseases.
• History of upper respiratory tract infection or other acute infections within 7 days prior to the first dose, or systemic use of antibiotics within 7 days.
• Known allergy to recombinant human hyaluronidase for injection or its formulation components; history of severe allergic reactions to any medication (e.g., angioedema); special dietary requirements or inability to comply with the standardized diet provided by the clinical site.
• Use of any prescription drugs, over-the-counter (OTC) medications, or herbal medicines within 4 weeks prior to screening (especially salicylates, cortisone, adrenocorticotropic hormone, estrogens, or antihistamines, except for routine vitamin supplements), or within 5 half-lives of the medication (whichever is longer).
• Vaccination within 1 month prior to administration.
• History of blood donation or blood loss ≥ 400 mL within 3 months prior to the use of the investigational product.
• Participation in any other clinical study and use of investigational/control products within 3 months prior to the investigational product administration.
• Positive for HBsAg, anti-HCV, anti-HIV, or the syphilis spirochete test.
• Sensory-motor disorders or autonomic movement disorders.
• Any condition which, in the investigator's judgment, would make the subject unable to comply with the protocol requirements, instructions, or study restrictions, such as an uncooperative attitude, inability to return for follow-up visits, or inability to complete the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of Anhui Medical University — Хэфэй

Идентификаторы

NCT: NCT07484893 · HLXTE-HAase02-FIH001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗