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NCT Number: NCT06548906

A Study of GZR4 Injection at Different Injection Sites

This trial is conducted in China. This study is a randomized, single-center, open, three-period crossover trial in healthy subjects to compare the PK, PD, and safety of a single administration of GZR4 at different injection sites (abdomen, deltoid region of upper arm, and thigh).

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Key information

Conditions

Healthy Subjects

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Study Site

Beijing, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 1. Signing the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol.
  • 2. A Male adult subjects aged 18-55 years old.
  • 3. Body mass index (BMI) between 19.0-24.0 kg/m2

Exclusion criteria

  • 1. Known or suspected hypersensitivity to investigational medical product(s) or related products.
  • 2. Participation in a clinical study of another study drug within 3 months prior to randomization.
  • 3. Physical examination, vital signs, laboratory examination, imaging examination, 12-lead electrocardiogram and other auxiliary examination results that the researchers considered abnormal clinical significance during screening.
  • 4. Donation of blood or blood products (more than 100mL) or significant blood loss (more than 200 mL) within 6 months prior to screening
  • 5. More than 14 units of alcohol per week within 3 months prior to randomization
  • 6. Smoking more than 5 cigarettes per day within 3 months prior to randomization

Treatment and study plan

GZR4 Injection

Drug

GZR4 Injection administered sc, once weekly.

Primary outcomes

  1. AUC0-672h

    Time frame: From Predose to 672 hours after a single dose

    Area Under the Concentration Versus Time Curve of GZR4 Injection From Time Zero to 672 hours

Secondary outcomes

  1. AUC0-∞

    Time frame: From Predose to 672 hours after a single dose

    Area Under the Concentration Versus Time Curve of GZR4 Injection From Time Zero to Infinity

  2. Cmax

    Time frame: From Predose to 672 hours after a single dose

    Maximum Concentration of GZR4 Injection

Study contacts

Contact information is provided by the study sponsor or research team.

wei zhao, PhD

CONTACT

[email protected]

01056456746

Sponsors and collaborators

Lead sponsor

Gan and Lee Pharmaceuticals, USA

Industry

Registry information

Official study title

A Trial Investigating the Pharmacokinetics, Pharmacodynamics and Safety of GZR4 Injection at Different Injection Regions in Healthy Subjects

Important dates

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