Pharmacokinetics of HR17031 Injection in Healthy Subjects

Pharmacokinetic Study of HR17031 Injection in Healthy Subjects (Single-center, Randomized, Open-label, 4 Cycles, 4 Sequences)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05031871

Enrollment

Registered

2021-09-02

Start date

2021-09-02

Completion date

2021-11-19

Last updated

2022-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief summary

To compare the pharmacokinetics and safety of HR17031 injection, SHR20004 injection and/or INS068 injection in healthy subjects

Interventions

DRUGHR17031 injection ；INS068 injection；SHR20004 injection

HR17031 injection dose+INS068 injection dose+SHR20004 injection dose+(INS068+SHR20004) injection dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
CL/F	Day1 to Day 26
Vz/F	Day1 to Day 26
ADA：anti-drug antibody	Day 1、Day 8、Day15、Day 22 or early termination
C-peptide concentrations within 24h after injection	Day1 to Day 23
Serum glucose within 24h after injection	Day1 to Day 23
Tmax ：time of maximum observed concentration	Day1 to Day 26
T1/2：Half-life time ；	Day1 to Day 26

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026