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Pharmacokinetics of HR17031 Injection in Healthy Subjects
Pharmacokinetic Study of HR17031 Injection in Healthy Subjects (Single-center, Randomized, Open-label, 4 Cycles, 4 Sequences)
Lead sponsor
Asset
Noiiglutide / HS-20004 / SHR20004
Oral · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
24
actual
Study population
Healthy volunteers
Key I/E criterion
•BMI 18-27
Primary endpoints
•Cmax：Cmax•AUC0-t ：Area under the curve from the time of dosing time to the last•AUC0-inf：Area under the curve from time 0 to infinity；
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. 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；
2. Fasting blood glucose during the screening is < 6.1 mmol/L；
Exclusion criteria
1. 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
2. Severe systemic disease, or a prior history of pancreatitis or other systemic problems within 1 month prior to screening;
3. Participate in any clinical trial of a drug or medical device within 3 months prior to screening (subject to signed informed consent)
Endpoints (10)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Glycemic / diabetes
2 endpointsSerum glucose within 24h after injection
Time frame:Day1 to Day 23
descriptive
C-peptide concentrations within 24h after injection
Time frame:Day1 to Day 23
concentration, descriptive
Safety / tolerability / PK
8 endpointsCmax：Maximum observed concentration
Time frame:Day1 to Day 26
concentration, descriptive
AUC0-t ：Area under the curve from the time of dosing time to the last measurable (positive) concentration；
Time frame:Day1 to Day 26
time to event, event
AUC0-inf：Area under the curve from time 0 to infinity；
Time frame:Day1 to Day 26
descriptive
Tmax ：time of maximum observed concentration
Time frame:Day1 to Day 26
concentration, descriptive
T1/2：Half-life time ；
Time frame:Day1 to Day 26
concentration, descriptive
CL/F
Time frame:Day1 to Day 26
descriptive
Vz/F
Time frame:Day1 to Day 26
descriptive
ADA：anti-drug antibody
Time frame:Day 1、Day 8、Day15、Day 22 or early termination
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.