The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Injectable SPN01 in Phase I.

Korábbi kezelés

• Allergy to SPN01: Known allergy to any component of the investigational drug SPN01, or a history of severe allergies.
• Active Infection: Any active infection requiring systemic treatment or uncontrolled infection within 14 days prior to the start of the study drug.
• Medication Use: Subjects who have taken any prescription drugs, over-the-counter medications, or herbal products within 2 weeks prior to the first dose, especially those who have used antacids (e.g., proton pump inhibitors, H2 receptor antagonists), P-glycoprotein (P-gp) inhibitors, or drugs associated with a risk of torsades de pointes, or those who have used any medications within 30 days prior to the first dose that inhibit or induce liver drug metabolism.
• Other Clinical Trials: Participation in another clinical trial and use of other investigational drugs within 30 days prior to screening.
• Vaccination: Receipt of any vaccination within 3 months prior to screening or plans to receive a vaccine during the study.

Más betegség

• History of Severe Systemic Diseases: A history of serious systemic diseases (including cardiovascular, digestive, urinary, respiratory, endocrine, immune, hematological, lymphatic, musculoskeletal, neurological diseases), liver or kidney dysfunction, or psychiatric disorders.
• Alcohol or Drug Abuse: A history of alcohol or drug abuse/dependence.
• Severe or Uncontrolled Psychiatric Disorder: Subjects with severe or uncontrolled psychiatric diseases.
• Infectious Disease Positive: Subjects who test positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or syphilis; subjects who test positive for hepatitis B virus (HBV) surface antigen.
• Needle Phobia: Subjects with a history of vasovagal response to blood draws or injections and those who cannot tolerate intravenous cannulation.
• Other Conditions: Any other condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the clinical trial.

Egyéb

• Pregnancy or Lactation: Female subjects who are pregnant (positive pregnancy test at screening) or breastfeeding.
• Pregnancy or Donation Plans: Subjects planning to become pregnant or donate sperm/eggs during the study or within 3 months after administration.
• Blood Donation or Blood Loss: Subjects who have donated blood or experienced total blood loss of ≥400 mL within the last 3 months.

• Body Mass Index (BMI): BMI between 19.0 kg/m² and 26.0 kg/m² (inclusive). For male subjects, body weight must be ≥50.0 kg; for female subjects, body weight must be ≥45.0 kg.
• Contraceptive Use: Males or females of childbearing potential must use effective contraception during the study and for 30 days after administration. Effective contraception includes sterilization, intrauterine hormonal devices, condoms, contraceptive pills/devices, abstinence, or vasectomy.
• Informed Consent: The subject must fully understand the purpose, nature, methods, and potential adverse effects of the study, voluntarily agree to participate, sign a written informed consent form, and comply with the study protocol.
• For healthy subjects-Age between 18 and 45 years (inclusive), either male or female.
• For healthy subjects-eGFR ≥ 90 ml/min/1.73 m².
• For healthy subjects-Screening phase laboratory results (blood count, blood biochemistry, urine routine, coagulation function) must be normal or clinically insignificant.
• For healthy subjects-Good general health with no major diseases, as determined by the investigator through history, vital signs, physical examination, clinical ECG, and laboratory test results.
• For colorectal cancer subjects-Age between 18 and 75 years (inclusive), either male or female.
• For colorectal cancer subjects-Pathologically confirmed diagnosis of colorectal cancer and scheduled for surgery (laparoscopic or open surgery).
• For colorectal cancer subjects-No prior targeted treatment for colorectal cancer (including radiotherapy, chemotherapy, targeted therapy, etc.).
• For colorectal cancer subjects-At least one evaluable lesion.