Pharmacokinetics of HR17031 Injection in Healthy Subjects
Pharmacokinetic Study of HR17031 Injection in Healthy Subjects (Single-center, Randomized, Open-label, 4 Cycles, 4 Sequences)
1 other identifier
interventional
24
1 country
1
Brief Summary
To compare the pharmacokinetics and safety of HR17031 injection, SHR20004 injection and/or INS068 injection in healthy subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 type-2-diabetes-mellitus
Started Sep 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2021
CompletedFirst Posted
Study publicly available on registry
September 2, 2021
CompletedStudy Start
First participant enrolled
September 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 19, 2021
CompletedOctober 13, 2022
October 1, 2022
3 months
August 16, 2021
October 12, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Cmax：Maximum observed concentration
Day1 to Day 26
AUC0-t ：Area under the curve from the time of dosing time to the last measurable (positive) concentration；
Day1 to Day 26
AUC0-inf：Area under the curve from time 0 to infinity；
Day1 to Day 26
Secondary Outcomes (7)
Tmax ：time of maximum observed concentration
Day1 to Day 26
T1/2：Half-life time ；
Day1 to Day 26
CL/F
Day1 to Day 26
Vz/F
Day1 to Day 26
Serum glucose within 24h after injection
Day1 to Day 23
- +2 more secondary outcomes
Study Arms (4)
Treatment group A
EXPERIMENTALHR17031 injection dose+INS068 injection dose+SHR20004 injection dose+(INS068+SHR20004) injection dose
Treatment group B
EXPERIMENTALINS068 injection dose+(INS068+SHR20004)injection dose+ HR17031 injection dose +SHR20004 injection dose
Treatment group C
EXPERIMENTALSHR20004 injection dose+ HR17031 injection dose +(INS 068+SHR20004) injection dose+ INS068 injection dose
Treatment group D
EXPERIMENTAL(INS 068+SHR20004) injection dose+ SHR20004 injection dose+ INS068 injection dose+ HR17031 injection dose
Interventions
HR17031 injection dose+INS068 injection dose+SHR20004 injection dose+(INS068+SHR20004) injection dose
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) ranges from 18 to 27 kg/m2 (both ends included), and the body weight is ≥50 kg for men and ≥45 kg for women；
- Fasting blood glucose during the screening is \< 6.1 mmol/L；
You may not qualify if:
- It has clinical significance for abnormalities Laboratory examination, if there is a clear reasonable reason, can be retested within a week, with the retest results Whether the subject meets the requirements
- Severe systemic disease, or a prior history of pancreatitis or other systemic problems within 1 month prior to screening;
- Participate in any clinical trial of a drug or medical device within 3 months prior to screening (subject to signed informed consent)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2021
First Posted
September 2, 2021
Study Start
September 2, 2021
Primary Completion
November 19, 2021
Study Completion
November 19, 2021
Last Updated
October 13, 2022
Record last verified: 2022-10