Logo 1 Logo 2

Clinical Trial Details

Trial ID: L2583
Source ID: NCT06086912
Associated Drug: Hr17031
Title: A Clinical Study to Compare the Bioavailability of HR17031 in Healthy Subjects at Different Sites
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: HR17031|DRUG: HR17031|DRUG: HR17031
Outcome Measures: Primary: 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 | Secondary: 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), 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
Sponsor/Collaborators: Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-11-07
Completion Date: 2023-12-12
Results First Posted:
Last Update Posted: 2024-02-01
Locations: Xuanwu Hospital Capital Medical University, Beijing, Beijing, 100032, China
URL: https://clinicaltrials.gov/show/NCT06086912