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Completed

NCT Number: NCT05954611

The Study of Single Dose Administration of GR2002 Injection in Chinese Health Volunteers

To evaluate the pharmacokinetic (PK) characteristics and pharmacological effect of GR2002 injection in Chinese healthy volunteers

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University People's Hospital

Beijing, China

About this study

This is a randomized, double-blind, placebo-controlled phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity characteristics of single subcutaneous administration of GR2002 injection in healthy adult Chinese subjects.

The initial dose group is 35mg, and the subsequent doses will gradually increase. Only after all subjects in the current dose group have completed at least 2 weeks of safety and tolerance observation and confirmed safe tolerance, can they enter the next dose group for medication observation until the "dose increase termination standard" is reached.

Follow up will be conducted for at least 12 weeks ± 3 days after completion of medication administration.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 1. Age of 18 to 55 years, inclusive, male or female 2. BMI between 19 kg/m2 and 26 kg/m2 (inclusive) 3. Healthy volunteers

Exclusion criteria

  • 1. History of chronic disease or serious disease 2. Subject with severe psychological or mental illness 3. Not enough washing-out period for previous therapy 4. Other.

Treatment and study plan

GR2002 injection

Biological

one single dose of GR2002 injection

Placebo

Biological

one single dose of placebo

Primary outcomes

  1. Incidence of Adverse Events (AE)

    Time frame: 85 days

    Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing

Secondary outcomes

  1. Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax)

    Time frame: 85 days

    Time to reach peak concentration (Tmax)

  2. Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)

    Time frame: 85 days

    Peak Plasma concentration (Cmax)

  3. Pharmacodynamics (PD): Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after GR2002 administration

    Time frame: 85 days

    Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after GR2002 administration

  4. Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)

    Time frame: 85 days

    Detection of anti-drug antibody (ADA) and neutralizing antibody (Nab)

Sponsors and collaborators

Lead sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase I, Randomized, Blinding, Single-dose, Placebo Control Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics Effect of GR2002 in Chinese Health Volunteers

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 20, 2023
Registry last updated
Aug 22, 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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