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The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-4729 injection in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group 1 | Experimental |
| |
| Treatment group 2 | Placebo Comparator |
| |
| Treatment group 3 | Experimental |
| |
| Treatment group 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-4729 injection | Drug | HRS-4729 injection |
| |
| HRS-4729 injection placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Screening period up to day 43. |
| Measure | Description | Time Frame |
|---|---|---|
| The maximum plasma concentration (Cmax) | Post-dose at day 1 to day 43. | |
| Time to maximum plasma concentration (Tmax) | Post-dose at day 1 to day 43. | |
| Terminal half-life (t1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinan Central Hospital | Jinan | Shandong | 250013 | China |
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| Drug |
HRS-4729 injection placebo |
|
| HRS9531 injection | Drug | HRS9531 injection |
|
| HRS9531 injection placebo | Drug | HRS9531 injection placebo |
|
| Acetaminophen | Drug | Acetaminophen |
|
| Post-dose at day 1 to day 43. |
| Apparent clearance (CL/F) | Post-dose at day 1 to day 43. |
| Apparent volume of distribution (Vz/F) | Post-dose at day 1 to day 43. |
| Anti-HRS-4729 antibodies | Post-dose at day 1 to day 43. |
| Changes from baseline in Fasting Body Weight | Run-in Period up to Day 113. |
| Changes from baseline in Fasting Plasma Glucose | Run-in Period up to Day 113. |
| Changes from baseline in Fasting Insulin | Run-in Period up to Day 113. |
| Changes from baseline in Fasting C-Peptide | Run-in Period up to Day 113. |
| Total fat mass | Run-in Period up to Day 113. |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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