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Completed

NCT Number: NCT05031871

Pharmacokinetics of HR17031 Injection in Healthy Subjects

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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；

Exclusion criteria

  • 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)

Treatment and study plan

HR17031 injection ；INS068 injection；SHR20004 injection

Drug

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

Primary outcomes

  1. Cmax：Maximum observed concentration

    Time frame: Day1 to Day 26

  2. AUC0-t ：Area under the curve from the time of dosing time to the last measurable (positive) concentration；

    Time frame: Day1 to Day 26

  3. AUC0-inf：Area under the curve from time 0 to infinity；

    Time frame: Day1 to Day 26

Secondary outcomes

  1. Tmax ：time of maximum observed concentration

    Time frame: Day1 to Day 26

  2. T1/2：Half-life time ；

    Time frame: Day1 to Day 26

  3. CL/F

    Time frame: Day1 to Day 26

  4. Vz/F

    Time frame: Day1 to Day 26

  5. Serum glucose within 24h after injection

    Time frame: Day1 to Day 23

  6. C-peptide concentrations within 24h after injection

    Time frame: Day1 to Day 23

  7. ADA：anti-drug antibody

    Time frame: Day 1、Day 8、Day15、Day 22 or early termination

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 2, 2021
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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