Skip to main content
OpenTrials
Completed

NCT Number: NCT05887895

To Compare the Pharmacokinetics and Pharmacodynamics of HR20014, INS068 and INS062 After Single Subcutaneous Injection in Healthy Subjects

This is a single-center, randomized, open, six-sequence, three-period crossover phase I clinical trial in healthy subjects to compare the PK/PD and safety profiles of single dose of HR20014, INS068, and INS062. In this study, 12 subjects were randomly assigned to 6 administration sequences in a ratio of 1:1:1:1:1:1, and HR20014, INS068 or INS062 injection were given subcutaneously three times before and after each sequence.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The second affiliated hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Able and willing to provide a written informed consent;
  • Male or female aged 18-45 at screening (both inclusive);
  • Subjects who are considered to be generally healthy, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator;
  • Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, body mass index (BMI) in 18.0~26.0 kg/m2 (both inclusive);
  • During the screening phase oral glucose tolerance test (OGTT), intravenous fasting plasma glucose ≥3.9 mmol/L and < 6.1 mmol/L; Glucose 2 hours after negative charge static pulse blood sugar <7.8mmol/L; and normal or abnormal insulin levels have no clinical significance.

Exclusion criteria

  • A history of recurrent or severe drug food allergy, or known or suspected allergy to any component of the study drug;
  • Have a history of hypertension;
  • Severe systemic infectious diseases within 1 month before screening;
  • Patients with a history of lower extremity deep vein thrombosis or high risk of lower extremity deep vein thrombosis;
  • Patients with serious diseases of the psychiatric, cardiovascular, respiratory, digestive, endocrine, blood, urogenital and other systems in the past, or existing diseases of the above systems, were judged by the researchers to be unfit to participate in this study;
  • Use of prescription drugs (topical eye/nasal drops and creams and occasional antipyretic and analgesic drugs such as acetaminophen within recommended doses are permitted) and over-the-counter drugs, and Chinese herbal medicine (regular vitamins are allowed) within 2 weeks before screening;
  • Presence of any abnormal and clinically significant laboratory tests.
  • ECG (12-lead electrocardiogram) showed abnormal and clinically significant.
  • Those who have participated in any drug clinical trials within 3 months or 5 half-life periods before screening (the elder shall prevail), who participated in clinical trials are defined as random, prior to screening.
  • Blood donation within 1 month before screening; Or patients with trauma or major surgical procedures who donated blood or lost blood ≥400 mL in the 3 months prior to screening.
  • Women who are pregnant, breastfeeding or planning to conceive, or women of childbearing potential (WOCBP) are reluctant to use appropriate contraception during the trial.
  • The investigators determined that other conditions were inappropriate for participation in this clinical trial.

Treatment and study plan

INS062 injection、INS068 injection、HR20014 injection

Drug

INS062 injection:A single dose of 0.4 DU/kg is administered to healthy subjects.

INS068 injection:A single dose of 0.4 U/kg is administered to healthy subjects.

HR20014 injection:A single dose of 0.4 U/kg is administered to healthy subjects.

Primary outcomes

  1. Area under the Glucose Infusion Rate (GIR) - time curve (Only for HR20014 and INS068)

    Time frame: 0 hour to 6 hours after dosing

  2. Area under the Glucose Infusion Rate (GIR) - time curve (Only for HR20014 and INS062)

    Time frame: 6 hours to 24 hours after dosing

Secondary outcomes

  1. Area under the Glucose Infusion Rate (GIR) - time curve

    Time frame: 0 hour to 96 hours after dosing

    Based on the absolute dose and concentration of INS068

  2. Maximum concentration of INS068

    Time frame: 0 hour to 96 hours after dosing

    Based on the absolute dose and concentration of INS068

  3. Area under the Glucose Infusion Rate (GIR) - time curve

    Time frame: 0 hour to 10 hours after dosing

    Based on the absolute dose and concentration of INS062

  4. Maximum concentration of INS062

    Time frame: 0 hour to 10 hours after dosing

    Based on the absolute dose and concentration of INS062

  5. Incidence and severity of adverse events (AEs)

    Time frame: from screening to 7-21 days after the last dosing

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Trial Comparing the Pharmacodynamics and Pharmacokinetics of HR20014, INS068 and INS062 in Healthy Subjects

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 5, 2023
Registry last updated
Jul 20, 2023

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.

Published trials that share one or more normalized conditions with this study.