Phase I Study of XTL6001 Injection in Healthy and Obese Subjects
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
Shanghai Xitaili Biomedicine Technology co., Ltd.
80 participants
Jun 13, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
XTL6001 is a triple-target Glucagon-like peptide-1 receptor （GLP-1R） relevant agonist, intending to manage overweight/obesity and other metabolic diseases
This intervention contains no active ingredients
Locations(1)
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NCT07205432