NCT03388515

A Study to Assess the Safety and Tolerability of SSS11 in Healthy Subjects.

A Randomized, Double-blinded, Placebo-controlled, Single-dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SSS11 Administered Intravenously in Healthy Volunteers.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

SSS11 is pegsiticase consisting of a recombinant uricase conjugated to multiple 20kDa PEG molecules. The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single dose SSS11 administered intravenously in healthy volunteers.

Detailed description

Objectives: Primary: • To assess the safety, tolerability of single dose SSS11 in healthy subjects Secondary: • To assess the pharmacokinetics, pharmacodynamics and immunogenicity of SSS-11 in healthy subjects Enrollment and Number of Arms (planned): 40 subjects will be assigned into 5 dosing cohorts (1.5, 3, 6, 12 and 24mg) with 5-10 subjects each. Original primary outcome Measures: Safety: Physical exam，ECG，Clinical laboratory tests，AE，SAE Tolerance assessment：MDT，DLT Original secondary outcome Measures: pharmacokinetics: Cmax, Tmax, AUC, CL, Vd, t1/2 pharmacodynamics: level of serum uric acid Immunogenicity ：anti-SSS11, anti-uricase and anti-PEG antibodies

Conditions

• Gout

Interventions

Type	Name	Description
BIOLOGICAL	SSS11	IV infusion for 60 min.
OTHER	placebo	IV infusion for 60 min.

Timeline

• Start date: 2017-10-09
• Primary completion: 2019-07-30
• Completion: 2020-01-31
• First posted: 2018-01-03
• Last updated: 2018-09-14

Locations

1 site across 1 country: China