A Study to Determine the Safety, Tolerability, PK and Preliminary PD of SSS11 in Chinese Healthy Adult Volunteers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04047394|
Recruitment Status : Not yet recruiting
First Posted : August 6, 2019
Last Update Posted : August 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gout||Drug: PEGylated recombinant candida urate oxidase||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Single-dose, Dose-increasing Study to Assess the Safety, Tolerability, PK and Preliminary PD of PEGylated Recombinant Candida Urate Oxidase (SSS11) for Injection in Chinese Healthy Adult Volunteers|
|Estimated Study Start Date :||August 30, 2019|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
Experimental: PEGylated recombinant candida urate oxidase
There are two parts (part A and part B), part A has five dose increasing groups, part B has three dose extension groups.
Part A: Group1：2mg, Group2：3mg, Group3：6mg, Group4：9mg, Group5: 12mg. Part B: Group1：3mg, Group2：6mg, Group3：9mg.
Drug: PEGylated recombinant candida urate oxidase
PEGylated recombinant candida urate oxidase is a combination of 20kDa linear polyethylene glycol (PEG) linked to Candida utilis recombinant uricase by succinimide succinate
Other Name: SSS11
- Adverse events (AEs) [ Time Frame: From the day signing in informed consent form to the day 56 post-dose ]Number of subjects with Adverse events (AEs)
- DLT [ Time Frame: From day 1 to day 56 ]Dose-LimitingToxicity of SSS11
- Cmax [ Time Frame: From beginning of drug administration to day 56 ]Maximum plasma concentration (Cmax) of single dose SSS11
- Tmax [ Time Frame: From beginning of drug administration to day 56 ]Peak plasma time [tmax] of single dose SSS11
- AUC [ Time Frame: From beginning of drug administration to day 56 ]Area under the plasma concentration versus time curve (AUC) of single dose SSS11
- Anti-urate oxidase antibody [ Time Frame: From pre-dose on week 2 up to week 1, 2, 4 and 7 post-dose. ]The immunogenicity of SSS11 was assessed in subjects by detecting the anti-urate oxidase antibody.
- Uric acid levels in blood [ Time Frame: From beginning of drug administration to day 56 ]This parameter was used to evaluate the PD of SSS11 in healthy humans.
- Uric acid levels in urine [ Time Frame: From beginning of drug administration to day 6 ]This parameter was used to evaluate the PD of SSS11 in healthy humans.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04047394
|Contact: Xianbo Li, MDemail@example.com|
|The Fifth Affiliated Hospital of Guangzhou Medical University|
|Guangzhou, Guangdong, China, 510799|
|Contact: Li Xianbo, MD|
|Principal Investigator: Xianbo LI, MD|