Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Huashan Hospital | OTHER |
| Hainan General Hospital | OTHER |
| Linyi People's Hospital | OTHER |
| The Second Affiliated Hospital of Chongqing Medical University |
Not provided
Not provided
Not provided
Not provided
To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in patients with acute gout
Phase Ib: single arm, open lable, single dose, dose escalation,design. There are 3 dose groups with 10 participant s in each group.
Phase II: randomized, double-blind, active control design.There are 2 dose groups of Genakumab for Injection with 30 participant s in each group and 1 group of Compound Betamethasone Injection with 30 praticipants.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genakumab for injection 50mg (Ib) | Experimental | subcutaneous injection, single dose |
|
| Genakumab for injection 100mg (Ib) | Experimental | subcutaneous injection, single dose |
|
| Genakumab for injection 195mg (Ib) | Experimental | subcutaneous injection, single dose |
|
| Genakumab for injection 100mg (II) | Experimental | Genakumab for injection, subcutaneous injection, single dose Placebo for Compound Betamethasone Injection, intramuscular injection, single dose |
|
| Genakumab for injection 195mg (II) | Experimental | Genakumab for injection, subcutaneous injection, single dose Placebo for Compound Betamethasone Injection, intramuscular injection, single dose |
|
| Compound Betamethasone Injection 1ml (II) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genakumab for Injection | Drug | 150 mg/1ml/bottle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Blood samples will be collected at indicated time points for pharmacokinetic analysis. | baseline, 24hours, 48hours, 120hours, Day 7, Day 14, Day 21, Day 28, Day 56, Day 84, Day 112 |
| pain intensity change from baseline to 72 hours post dose as measured on a 0-100 mm Visual Analog Scale (VAS) | 0-100 mm Visual Analog Scale(VAS): 0= no pain and 100= severe pain | 72 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | Adverse events (AEs) were defined as any unfavourable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody | baseline, Day 14, Day 28, Day 56, Day 84, Day 112 |
Inclusion Criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hejian Zou | Huashan Hospital | Principal Investigator |
| Jing Zhang | Huashan Hospital of Fudan Univeisity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Huashan Hospital affiliated to Fudan University | Shanghai | Shanghai Municipality | 310000 | China |
Not provided
| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
| OTHER |
| Changhai Hospital | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Shengjing Hospital | OTHER |
| Affiliated Hospital of Nantong University | OTHER |
Group A : 50mg by single subcutaneous injection; Group B : 100mg by single subcutaneous injection Group C : 195mg by single subcutaneous injection;Group D : 100mg by single subcutaneous injection Group E : 195mg by single subcutaneous injection; Group F: 1ML Compound Betamethasone Injection by single intramuscular injection
Not provided
Not provided
Phase II is double-blind, participants and investigators are blind.
| Active Comparator |
Compound Betamethasone Injection, 1 ml, intramuscular injection, single dose Placebo for Genakumab for injection, 100mg, subcutaneous injection, single dose |
|
| Placebo for Genakumab for Injection | Drug | The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection |
|
| up to 16 weeks |
| High Sensitivity C-reactive Protein (hsCRP) | High sensitivity C-reactive protein (hsCRP) was determined in serum at all visits (except Visit 2 and Visit 4 ) in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. | at 72 hours and 7 days, 4, 8 and 12 weeks post-dose |