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Completed

NCT Number: NCT06548997

A Phase I Study of GZR18 Injection in Healthy Subjects

This trial is conducted in China. The aim of the trial is to evaluate the safety and tolerability of GZR18 injection in healthy subjects following single dose and once-weekly dose for 2 consecutive weeks until reaching the target dose.

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Key information

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 1. Subjects sign informed consent voluntarily.
  • 2. Chinese adult subjects, male or female.
  • 3. Age 18-55 at screening (both included).
  • 4. At screening and baseline, 19.0 kg/m2 ≤ BMI ≤ 26.0 kg/m2 (male ≥55.0 kg, female ≥45.0 kg).
  • 5. Female subjects were human chorionic gonadotophin (HCG) negative at screening and baseline.

Exclusion criteria

  • 1. History of dizziness with blood and needles.
  • 2. Known or suspected allergy to study related products; or a history of drug and food allergies; or a history of allergy-related diseases.
  • 3. Participants who participated in other clinical trials and were given the investigational drug or medical device intervention within 90 days prior to screening.
  • 4. Blood donation, surgery, or trauma with significant blood loss (more than or equal to 400 mL, except for menstrual blood loss in women) within 12 weeks prior to screening.
  • 5. Any clinically significant medical history judged by the investigator, including but not limited to: lung, gastrointestinal, liver, nervous system, kidney, genitourinary and endocrine, skin, or blood disorders, especially a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 , and a history of pancreatitis (acute or chronic).
  • 6. At screening or baseline, physical examination showed clinically significant abnormalities judged by the investigator.

Treatment and study plan

GZR18

Drug

5 μg/kg-maximum tolerated dose (MTD), single dose or two doses

Placebo

Other

administered the same volume as GZR18

Primary outcomes

  1. TEAE

    Time frame: after 28/35 days of treatment

    Incidence of treatment-emergent adverse events (TEAE)

Secondary outcomes

  1. Cmax

    Time frame: 28/35 days

    The peak concentration after reaching the target dose

  2. AUClast

    Time frame: 28/35 days

    the area under the concentration-time curve from 0 to the last time that the concentration can be accurately measured

  3. AUC0-inf

    Time frame: 28/35 days

    the area under the concentration-time curve from 0 to infinity

  4. Tmax

    Time frame: 28/35 days

    the peak time

  5. λz

    Time frame: 28/35 days

    the elimination rate constant

  6. t1/2

    Time frame: 28/35 days

    the half-life

  7. tlag

    Time frame: 28/35 days

    retention time

  8. CL/F

    Time frame: 28/35 days

    apparent clearance rate

  9. Vz/F

    Time frame: 28/35 days

    apparent volume of distribution

  10. AUC%extra

    Time frame: 28/35 days

    extrapolation percentage of AUC0-in

  11. MRT

    Time frame: 28/35 days

    average retention time

  12. AUCglucose0-14h

    Time frame: 28/35 days

    area under the concentration-time curve of fasting blood glucose from 0 to 14 hours after each administration

  13. AUCc-peptide0-14h

    Time frame: 28/35 days

    area under the concentration-time curve of fasting C-peptide from 0 to 14 hours after each administration

  14. AUCinsulin0-14h

    Time frame: 28/35 days

    area under the concentration-time curve of fasting insulin from 0 to 14 hours after each administration

  15. body weight

    Time frame: 28/35 days

  16. body mass index (BMI)

    Time frame: 28/35 days

Sponsors and collaborators

Lead sponsor

Gan and Lee Pharmaceuticals, USA

Industry

Registry information

Official study title

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GZR18 Injection in Healthy Subjects Following Single Dose and Once-weekly Dose for 2 Consecutive Weeks Until Reaching the Target Dose

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 12, 2024
Registry last updated
Aug 14, 2024

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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