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A Study Exploring Efficacy of Pegloticase in Subjects With Asymptomatic Hyperuricemia

NCT05302388 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-12-27

No results posted yet for this study

Summary

The main purpose To evaluate the safety and tolerability of pegloticase in subjects with asymptomatic hyperuricemia by single intravenous infusion at different doses, and to provide a basis for multiple doses of Pegloticase in subjects with asymptomatic hyperuricemia.

A secondary purpose To evaluate the pharmacokinetics, pharmacodynamics and immunogenicity of Pegloticase with single-pass intravenous drip in subjects with asymptomatic hyperuricemia.

Exploratory purpose Plasma uricase activity (pUox) analysis of pegloticase with single-pass intravenous drip in subjects with asymptomatic hyperuricemia.

Conditions

  • Asymptomatic Hyperuricemia

Interventions

DRUG

SIBP-R002

SIBP-R002: injection; strength: 1, 2, 4, 8 or 12 mg; dose escalation and the first group is 1mg (intravenous infusion, 5 groups, the first group consisted of four people, and the other groups consisted of eight).

DRUG

Dexamethasone or Methyl prednisolone

Intravenous infusion, 5mg or 1\~2mg/kg. These were administered within 30 minutes prior to infusion of the experimental drug.

DRUG

Diphenhydramine

10mg, intramuscular injection.These were administered within 30 minutes prior to infusion of the experimental drug.

DRUG

Placebo

The same volume of placebo as SIBP-R002: injection; strength: the same volume of placebo as SIBP-R002 of 1, 2, 4, 8 or 12 mg (intravenous infusion, 5 groups, the first group consisted of one people, and the other groups consisted of two). The rule and dose of placebo were the same as SIBP-R002.

Sponsors & Collaborators

  • The First Affiliated Hospital of Bengbu Medical University

    collaborator OTHER

  • Shanghai Institute Of Biological Products

    lead INDUSTRY

Principal Investigators

  • The First Affiliated Hospital of Bengbu Medical College The First Affiliated Hospital of Bengbu Medical College, Master · Shanghai Institute Of Biological Products

  • Huan Zhou · The First Affiliated Hospital of Bengbu Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-11
Primary Completion
2023-01-09
Completion
2023-01-09

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05302388 on ClinicalTrials.gov