Clinical trials: Gout
Primary Gout, Hyperuricemia
Study on the Bioavailability of Three Different Prescription Processes of SHR4640 Tablets in Healthy Volunteers
The primary objective of the study is to evaluate the relative bioavailability of three different prescription processes of SHR4640 tablets in healthy volunteers.
- Trial name
- NCT04586803
- Testing
- SHR4640
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Acute Gout Flare
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic of IBI3011
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of recombinant Anti-IL-RAP humanised monoclonal antibody injection in healthy Chinese subjects (Part A) and subjects with acute gout flare…
- Trial name
- NCT07295496
- Testing
- IBI3011
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Hyperuricemia With or Without Gout
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral F-02-2-Na Tablets in Adult Subjects
The primary objective of this study is to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of ascending single orally administered doses of F-02-2-Na in adult subjects (to include the Mass Balance) \& multiple…
- Trial name
- NCT07324434
- Testing
- F-02-2-Na Tablet (0.5 mg), F-02-2-Na Tablet (5 mg), F-02-2-Na Tablet (10 mg)
- Where
- China
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd.
Gout; Hyperuricemia
Single Dose Study of SHR4640 in Healthy Subjects
The objective of the study is to assess the safety, tolerance, food effect, pharmacokinetic and pharmacodynamic properties of single dose adminstration of SHR4640 in healthy volunteers.
- Trial name
- NCT02815839
- Testing
- SHR4640
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Gout
RDEA3170 PK/PD Study
The purpose of this study is to examine the pharmacokinetic and pharmacodynamic effect of RDEA3170 when given as single or multiple doses
- Trial name
- NCT02608710
- Testing
- RDEA3170 4.5 mg, RDEA3170 6 mg, RDEA3170 12 mg
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ardea Biosciences, Inc.
Pharmacokinetics
Pharmacokinetic and Exploratory Electrocardiogram (ECG) Study
This study will characterize the pharmacokinetics of colchicine after an oral dosing regimen of 4.8 mg over 6 hours. In addition it will compare the electrocardiogram (ECG) changes, if any, from this dosing regimen to that of a…
- Trial name
- NCT01018420
- Testing
- Colchicine, Moxifloxacin
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Hyperuricemia, Gout
Study 102: Multiple Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)
The purpose of this Phase I study is to evaluate the safety and tolerability of ALLN-346 in in normal healthy volunteers, in an ascending dose design.
- Trial name
- MAD (NCT04829435)
- Testing
- ALLN-346
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Allena Pharmaceuticals
Gouty Arthritis (GA)
A Bioequivalence Study of Two Different Dosage Form of Genakumab
The purpose of this study is to investigate whether Genakumab Injection is bioequivalent to Genakumab for Injection.
- Trial name
- NCT06451848
- Testing
- Genakumab Injection (T, Solution for injection), Genakumab for Injection (R, Powder for solution for injection)
- Where
- China
- Volunteers
- 178 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Hyperuricemia With or Without Gout
Safety and Food Effect on Single-Dose Bioavailability of F-02-2-Na in Healthy Adult Subjects
The study is to evaluate the impact of food on the pharmacokinetics of F-02-2-Na in healthy adult subjects by observing the changes in the drug's pharmacokinetic profile-particularly in its absorption process-before and after…
- Trial name
- NCT07346027
- Testing
- Fasting administration of F-02-2-Na (50mg) - Fed administration of F-02-2-Na (50mg), Fed administration of F-02-2-Na (50mg) - Fasting administration of F-02-2-Na (50mg)
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd.
Gout
MPC-004 for the Treatment of an Acute Gout Flare
This study is a multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-comparison to determine the efficacy and safety of a standard-dose of colchicine (4.8 mg) versus low-dose colchicine (1.8 mg) or…
- Trial name
- AGREE (NCT00506883)
- Testing
- High Dose Colchicine (4.8 mg total dose), Low Dose Colchicine (1.8mg total dose)
- Where
- 83 sites in United States
- Volunteers
- 185 people, healthy volunteers welcome
- Sponsor
- Takeda
Gout
Clinical Study to Evaluate the Pharmacokinetic Characteristics Between TMX-67 and Feburic® in Healthy Volunteers
This study was designed to compare and evaluate the pharmacokinetic characteristics of febuxostat after single oral administration of TMX-67 (test drug) and Feburic® tablet in healthy adults; and to evaluate safety and tolerance…
- Trial name
- NCT01563432
- Testing
- Feburic®, TMX-67
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- SK Chemicals Co., Ltd.
Gout, Hyperuricemia
Safety and Efficacy Study of Intramuscular Uricase-PEG 20
The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of single and multiple intramuscular doses of Uricase-PEG 20
- Trial name
- NCT01038947
- Testing
- Uricase-PEG 20
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- EnzymeRx
Gout, Hyperuricemia
Relative Bioavailability Study to Assess an LC350189 Tablet Compared to an LC350189 Capsule in Healthy Adults
This is an open-label, randomized, crossover, single dose study. Two single doses of LC350189(tablet or capsule formulations) will be administered with a washout period of at least 4-day between the doses to investigate the…
- Trial name
- NCT04886050
- Testing
- LC350189 Tablet, LC350189 Capsule
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- LG Chem
Gout, Hyperuricemia
Renal PK Study of LC350189
This is a Phase 1, open-label, parallel-group, multiple-dose study designed to assess the effect of renal impairment on the PK and PD of LC350189.
- Trial name
- NCT04066712
- Testing
- LC350189 200 mg
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- LG Chem
Pharmacokinetics
Pharmacokinetic Study of an Acute Gout Regimen
This study aims to characterize the pharmacokinetic profile of colchicine after a regimen of 1.8 mg over two hours. A secondary goal is to evaluate the safety and tolerability of this regimen in healthy volunteers.
- Trial name
- NCT01017042
- Testing
- colchicine tablets
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Gout, Hyperuricemia
PK and Safety Evaluation Study of SAP-001 in Adult Subjects With Normal and Impaired Renal Function
This is a multicenter, open-label, non-randomized, parallel-group, single-dose, 2-part, adaptive study in which up to approximately 32 adult subjects will be enrolled in one of 4 groups (8 subjects per group) with varying degrees…
- Trial name
- NCT06729853
- Testing
- SAP-001
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Shanton Pharma Pte. Ltd.
Gout
Food Effect Study of Febuxostat XR in Healthy Participants
The purpose of this study is to assess the effect of food on the bioavailability of febuxostat after a single oral dose of 80 mg febuxostat XR and to evaluate the pharmacokinetics (PK) of febuxostat after single oral doses of 40…
- Trial name
- NCT02374164
- Testing
- Febuxostat XR
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Takeda
Gout, Hyperuricemia
Safety and Efficacy Study of Intravenous Uricase-PEG 20
The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of single intravenous doses of Uricase-PEG 20.
- Trial name
- NCT01021241
- Testing
- Uricase-PEG 20
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- EnzymeRx
Hyperuricemia or Gout
D-0120 Safety and PK/PD Study in China
It is a randomized, double-blind, placebo-controlled, multiple-administration, multiple-dose, dose-escalating, phase Ib/IIa clinical study to evaluate the safety, tolerability, PK and PD of D-0120 in healthy subjects and…
- Trial name
- NCT03923868
- Testing
- D-0120
- Where
- 6 sites in China
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- InventisBio Co., Ltd
Gout
A Single Dose Study of SHR4640 in Healthy Male Volunteers
This is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose Phase I trial.
- Trial name
- NCT03015948
- Testing
- SHR4640
- Where
- Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Atridia Pty Ltd.