Assessment of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of GenSci120 in Healthy Adult Participants in China.

Korábbi kezelés

• Recent trauma, surgery, or GI issues affecting absorption.
• Live vaccines within a month prior to screening.
• Recent use of immunosuppressive or targeted therapies.
• Medication use within 14 days prior to randomization.
• Positive drug screen for specific substances.
• Recent soft/hard drug use within specified periods.

Más betegség

• Allergy to GenSci120 or severe allergies.
• Significant medical conditions impacting study outcome.
• History of malignant tumors, including listed cancers.
• Seizure history, head injury causing unconsciousness.
• Psychiatric disorders impairing daily activities or cognitive issues.
• Severe immunodeficiency (e.g., HIV).
• Recent severe infections or antimicrobial treatments.
• Positive for hepatitis B/C, HIV, syphilis during screening.
• Other conditions deemed unsuitable by investigators.

Egyéb

• Injection site issues affecting evaluation.
• Abnormal vital signs/ECG: BP extremes, QTcF \>450ms.
• Positive TB test via IGRA.
• Participation in other clinical trials recently/currently.
• Excessive alcohol consumption (over six months).
• Heavy smoking, unwillingness to quit, positive nicotine tests.
• Blood donation/product receipt recently or poor venous access.
• Study staff involved in the trial.

• Ages 18-55; ≥3 per gender for each cohort.
• BMI: 18-30; Weight: ≥50 kg (male), ≥45 kg (female).
• No clinically significant abnormalities in medical history, physical exam, vital signs, or lab/ECG/pulmonary imaging.
• Men/WOCBP must use effective contraception throughout study; no plans to conceive; WOCBP must have negative pregnancy test and not breastfeeding. Women of non-childbearing potential: post-hysterectomy/salpingectomy or postmenopausal (FSH \>40 IU/L).
• Able to provide informed consent; willing to comply with all study requirements