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| Name | Class |
|---|---|
| Peking Union Medical College Hospital | OTHER |
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To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in Chinese healthy adult volunteers
There are 5 dose groups with 8 participants in each group, including 6 participants in the experimental group and 2 participants in the placebo control group.
Since the strength of experimental drug is 150mg/1ml/ bottle, participants with a single dose of more than 150mg need to be given subcutaneously at different sites in two or more times
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genakumab injection:5 groups | Experimental | 150 mg/1ml/bottle, single subcutaneous injection. Group A : 0.3mg/kg, Group B : 1mg/kg, Group C : 2mg/kg, Group D:4mg/kg, Group E : 6mg/kg, |
|
| Placebo for this trial : 5 groups | Placebo Comparator | The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection, 150 mg/1ml/bottle, single subcutaneous injection. Group A : 0.3mg/kg, Group B : 1mg/kg, Group C : 2mg/kg, Group D:4mg/kg, Group E : 6mg/kg, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genakumab | Drug | 150 mg/1ml/bottle, single subcutaneous injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum Genakumab concentration | Baseline, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113 after administration | |
| Area under the serum Genakumab concentration-time curve | Baseline, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113 after administration | |
| Measurement of the serum IL-1β for pharmacodynamics study | Baseline, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113 after administration |
| Measure | Description | Time Frame |
|---|---|---|
| The frequency of adverse events (AE) | From screening to follow-up period (up to day 22) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luocheng Xu | Contact | 800-820-0469 | xuluocheng@gensci-china.com |
| Name | Affiliation | Role |
|---|---|---|
| Rui Chen | Clinical Pharmacology Research Center of Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Research Center of Peking Union Medical College Hospital | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40711661 | Derived | Liu H, Yuan Y, Tian W, Luo T, Xu Q, Zhu X, Chen R. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Firsekibart, an Anti-interleukin-1beta Monoclonal Antibody, in Healthy Chinese Participants: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study. Adv Ther. 2025 Sep;42(9):4611-4625. doi: 10.1007/s12325-025-03279-4. Epub 2025 Jul 25. |
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| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Double-blind (participant, investigator), excluding one non-blind investigator doctor.
| Placebo for this trial |
| Drug |
The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection, 150 mg/1ml/bottle, single subcutaneous injection. |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |