A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout.

Summary

To evaluate the safety and tolerability of peguricase for injection with methotrexate in patients with gout who remain uncontrolled after standardized treatment with conventional uric acid-lowering drugs, to determine the recommended dose for phase II clinical trials, and to provide basis for formulation of administration regimen for phase II clinical trials.

Conditions

• Gout

Interventions

DRUG

SIBP-R002

Injection; strength: 4mg. Each group consists of 12 participants. Firstly, 4 sentinel participants were enrolled in the single dose phase of peruricase for injection and methotrexate. After the sentinel participants completed a 5-day safety observation of the single dose, the remaining 8 participants in this group can be enrolled simultaneously. If there are no special circumstances, the participants in this group will enter the multi-dose stage of peruricase for injection combined with methotrexate within 2-4 weeks after completing a single dose.

DRUG

SIBP-R002

Injection; strength: 8mg. Each group consists of 12 participants. Firstly, 4 sentinel participants were enrolled in the single dose phase of peruricase for injection and methotrexate. After the sentinel participants completed a 5-day safety observation of the single dose, the remaining 8 participants in this group can be enrolled simultaneously. If there are no special circumstances, the participants in this group will enter the multi-dose stage of peruricase for injection combined with methotrexate within 2-4 weeks after completing a single dose.

DRUG

SIBP-R002

Injection; strength: 12mg. Each group consists of 12 participants. Firstly, 4 sentinel participants were enrolled in the single dose phase of peruricase for injection and methotrexate. After the sentinel participants completed a 5-day safety observation of the single dose, the remaining 8 participants in this group can be enrolled simultaneously. If there are no special circumstances, the participants in this group will enter the multi-dose stage of peruricase for injection combined with methotrexate within 2-4 weeks after completing a single dose.

DRUG

Methotrexate

Combination drugs: Methotrexate, dose15 mg, oral.

Sponsors & Collaborators

• The First Affiliated Hospital of Bengbu Medical University

  collaborator OTHER

• The First Affiliated Hospital of Henan University of Science and Technology

  collaborator OTHER

• Shanghai Institute Of Biological Products

  lead INDUSTRY

Principal Investigators

• Huan Zhou, Master · Co., Ltd Shanghai Institute Of Biological Products

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-03

Primary Completion

2026-12-30

Completion

2026-12-30

Countries

• China

Study Locations