A Randomized, Double-blind, Placebo-controlled Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Administration of XTL6001 Injection in Healthy and Obese Subjects
This is a multicenter, randomized, double-blind, placebo-controlled Phase I study to evaluate safety, PK and PD of single ascending dose (SAD) and multiple ascending dose (MAD) of XTL6001 injection in healthy and obese adult subjects. SAD study: Includes 5 dose cohorts, with 40 subjects planned for enrollment. MAD study Includes 2 dose cohorts, with 30 subjects planned for enrollment.
• Age ≥ 18 and \< 65 years at screening.
• Body mass index (BMI) ≥ 18.5 kg/m² and \< 28.0 kg/m² at screening.
• Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening.
• Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions.
• Age ≥ 18 and \< 65 years at screening.
• BMI ≥ 18.5 kg/m2且 \< 40.0kg/m².
• Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening.
• Stable body weight (fluctuation \< 5%) for at least 3 months prior to screening.
• Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions.