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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XTL6001 | Experimental | Interventional: The SAD study involves single administration of XLT6001, while the MAD study involves administration of XLT6001 for no more than 4 weeks. |
|
| Placebo | Placebo Comparator | Placebo: The SAD study involves single administration of Placebo, while the MAD study involves administration of Placebo for no more than 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XTL6001 | Drug | XTL6001 is a triple-target Glucagon-like peptide-1 receptor (GLP-1R) relevant agonist, intending to manage overweight/obesity and other metabolic diseases |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events) | SAD: up to Day 8 MAD: up to Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| The maximum plasma concentration (Cmax) of XTL6001 | Cmax - Maximum plasma concentration | 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 |
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Inclusion Criteria:
Inclusion Criteria for Subjects in SAD part:
Inclusion Criteria for Subjects in MAD part:
Exclusion Criteria:
Exclusion Criteria for Subjects in SAD part:
Exclusion Criteria for Subjects in MAD part:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao Hua Hao, Ph.D. in Medicine | Contact | 010-63926883 | xiaohualuck@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Shijitan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100038 | China |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Placebo | Drug | This intervention contains no active ingredients |
|
The time to maximum concentration (Tmax) of XTL6001 |
| 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 | 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 | 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 | 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. |
| Body weight | Body weight | MAD: up to Day57 |
| Body mass index (BMI) | Body mass index | MAD: up to Day57 |
| Waist circumference | waist circumference | MAD: up to Day57 |
| Waist-to-hip ratio | waist-to-hip ratio | MAD: up to Day57 |
| Blood lipids | Total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, apolipoprotein A1 and apolipoprotein B | MAD: up to Day57 |
| Blood glucose | Blood glucose | MAD: up to Day57 |
| Insulin | Insulin | MAD: up to Day57 |
| Uric acid | Uric acid | MAD: up to Day57 |
| Anti-drug antibodies (ADA) | Incidence of anti-drug antibodies (ADA) | MAD: up to Day57 |
| ADA | Time to ADA positivity | MAD: up to D57 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |