drugset / Trial / NCT04067492
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Evaluation of RPH-104 Administered at Different Doses to Patients With Acute Gout Attack
Phase 2
Terminated
47 enrolled
R-Pharm
Center of Pharmaceutical Analytics LLC · collabCovance · collabData Matrix Solutions · collabOCT LLC · collabUnimed Laboratories · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary goal of the study was to evaluate the parameters of efficacy, pharmacokinetics, pharmacodynamics, safety and tolerability of a single dose of RPH-104 in adult patients with acute gout attack.
Timeline
- Start
- 2018-03-26
- Primary completion
- 2020-03-16
- Completion
- 2020-05-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Diclofenac | Other / unclassified | 25 mg | Oral |
| Subject | Goflikicept | Monoclonal antibody | 4 mg | Subcutaneous |
| Subject | Goflikicept | Monoclonal antibody | 20 mg | Subcutaneous |
| Subject | Goflikicept | Monoclonal antibody | 40 mg | Subcutaneous |
| Subject | Goflikicept | Monoclonal antibody | 80 mg | Subcutaneous |
| Subject | Goflikicept | Monoclonal antibody | 160 mg | Subcutaneous |