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The purpose of this study is to evaluate the bioavailability and safety of HR17031 injection in healthy subjects at different sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sequence 1 | Experimental |
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| sequence 2 | Experimental |
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| sequence 3 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR17031 | Drug | Receive a single dose of HR17031 at every period (First period:abdomen. Second period. upper arm. Third period: thigh). |
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| Measure | Description | Time Frame |
|---|---|---|
| After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Area Under the Concentration versus time curve (AUC0-t) | Start of treatment up to Day 26 | |
| After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Area Under the Concentration versus time curve (AUC0-∞) | Start of treatment up to Day 26 | |
| After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Maximum Concentration (Cmax) | Start of treatment up to Day 26 |
| Measure | Description | Time Frame |
|---|---|---|
| After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Time to maximum concentration (Tmax) | Start of treatment up to Day 26 | |
| After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Apparent terminal half-life (t1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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1. The following laboratory or auxiliary examination abnormalities are present during the screening period:
2. The following diseases or medical history are present:
3. Medications (prescription or over-the-counter), food supplements, vitamins, and Chinese herbal medicines used within 2 weeks before the start of treatment are prohibited. Local application of eye/nose drops and ointments are allowed.
4. The following conditions are prohibited:
5. Any other condition judged by the investigator to interfere with the evaluation of the trial results or to be inappropriate for participation in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital Capital Medical University | Beijing | Beijing Municipality | 100032 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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This study is a single-center, randomized, open-label, three-period, and three-sequence crossover design trial, consisting of three sequences (sequence 1, sequence 2 and sequence 3) and three periods (first period, second period and third period). Each sequence receives a same dose of HR17031 at every period.
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| HR17031 | Drug | Receive a single dose of HR17031 at every period (First period:upper arm. Second period: thigh. Third period: abdomen). |
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| HR17031 | Drug | Receive a single dose of HR17031 at every period (First period:thigh. Second period: abdomen. Third period: upper arm). |
|
| Start of treatment up to Day 26 |
| After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Clearance (CL/F) | Start of treatment up to Day 26 |
| After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Apparent volume of distribution (Vz/F) | Start of treatment up to Day 26 |
| Safety indicators: Adverse events (AE, including Injection site reactions, Hypoglycemia events, etc.), serious adverse events (SAE). | Screening period up to Day 26 |
| Immunogenicity indicators: anti-Noiiglutide antibodies | Start of treatment up to Day 26 |
| Immunogenicity indicators: anti-INS068 antibodies | Start of treatment up to Day 26 |
| D004700 | Endocrine System Diseases |