Peking University People's Hospital
Beijing, China
NCT Number: NCT05954611
To evaluate the pharmacokinetic (PK) characteristics and pharmacological effect of GR2002 injection in Chinese healthy volunteers
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Beijing, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
one single dose of GR2002 injection
one single dose of placebo
Time frame: 85 days
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing
Time frame: 85 days
Time to reach peak concentration (Tmax)
Time frame: 85 days
Peak Plasma concentration (Cmax)
Time frame: 85 days
Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after GR2002 administration
Time frame: 85 days
Detection of anti-drug antibody (ADA) and neutralizing antibody (Nab)
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Industry
A Phase I, Randomized, Blinding, Single-dose, Placebo Control Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics Effect of GR2002 in Chinese Health Volunteers
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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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