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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGIncidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)
Time frame: SAD: up to Day 8 MAD: up to Day 57
The maximum plasma concentration (Cmax) of XTL6001
Cmax - Maximum plasma concentration
Time frame: Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.
Tmax of XTL6001
The time to maximum concentration (Tmax) of XTL6001
Time frame: Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.
Elimination half-life (T1/2) of XTL6001
t1/2 - Elimination half-life
Time frame: Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.
Area under the plasma concentration-time curve during one dosing interval (AUC) 0-tau of XTL6001
AUC0-tau - Area under the plasma concentration-time curve during one dosing interval
Time frame: Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.
AUC0-t of XTL6001
AUC0-t - Area under the plasma concentration-time curve from time zero to the last measurable concentration
Time frame: Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.
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Body weight
Body weight
Time frame: MAD: up to Day57
Body mass index (BMI)
Body mass index
Time frame: MAD: up to Day57
Waist circumference
waist circumference
Time frame: MAD: up to Day57
Waist-to-hip ratio
waist-to-hip ratio
Time frame: MAD: up to Day57
Blood lipids
Total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, apolipoprotein A1 and apolipoprotein B
Time frame: MAD: up to Day57
Blood glucose
Blood glucose
Time frame: MAD: up to Day57
Insulin
Insulin
Time frame: MAD: up to Day57
Uric acid
Uric acid
Time frame: MAD: up to Day57
Anti-drug antibodies (ADA)
Incidence of anti-drug antibodies (ADA)
Time frame: MAD: up to Day57
ADA
Time to ADA positivity
Time frame: MAD: up to D57