A Study to Evaluate the Safety, Tolerability, and PK Profile of Single and Multiple Doses TJ202 in Patient With Systemic Lupus Erythematosus

Phase 1

Terminated

• Conditions: Systemic Lupus Erythematosus (SLE)
• Interventions: Drug: Placebo; Biological: TJ202 injection

• Registration Number: NCT05140824
• Lead Sponsor: TJ Biopharma Co., Ltd.

Brief Summary

A Multicenter, Randomized, Double-blind, Placebo-Controlled, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Single and Multiple Doses of TJ202 in Patients with Systemic Lupus Erythematosus

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-04
• Study First Submitted QC: 2021-11-21
• Study First Posted: 2021-12-01
• Study Start: 2021-12-30
• Primary Completion: 2022-12-14
• Study Completion: 2022-12-14
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	0.9% sodium chloride solution
TJ202	TJ202 injection	TJ202 injection

Primary Outcome Measures

Name	Time	Method
Rate of Adverse Events	113 days post last dose for multi- dose	Evaluate the rate of adverse events
Pharmacokinetic(PK) Parameters: Cmax	113 days post last dose for multi- dose	Cmax
Pharmacokinetic(PK) Parameters: Tmax	113 days post last dose for multi- dose	Tmax
Pharmacokinetic(PK) Parameters: AUC	113 days post last dose for multi- dose	AUC0-tlast

Trial Locations

Locations (2)

The Second Affiliated Hosptial Zhejiang University School of Medicine; 🇨🇳 Zhejiang, Hangzhou, China

Huashan Hospital affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China