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To evaluate the pharmacokinetic (PK) characteristics and pharmacological effect of GR2002 injection in Chinese healthy volunteers
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GR2002 injection | Experimental | GR2002 subcutaneous injection |
|
| placebo | Placebo Comparator | placebo subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GR2002 injection | Biological | one single dose of GR2002 injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AE) | Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing | 85 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax) | Time to reach peak concentration (Tmax) | 85 days |
| Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax) | Peak Plasma concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yi Fang, MD | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Placebo |
| Biological |
one single dose of placebo |
|
| 85 days |
| Pharmacodynamics (PD): Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after GR2002 administration | Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after GR2002 administration | 85 days |
| Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab) | Detection of anti-drug antibody (ADA) and neutralizing antibody (Nab) | 85 days |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |