NCT07363954

To Evaluate the Safety and Tolerability of STR-P004 for the Treatment of Immune-mediated Kidney Diseases

A Clinical Study on the Safety, Efficacy, and Pharmacokinetics of STR-P004 for the Treatment of Immune-Mediated Kidney Diseases

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Starna Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, non-randomized, open-label, single-arm exploratory clinical study, using Bayesian Optimal Interval (BOIN) design. Three dose groups are planned: DL1 XX mg/kg, DL2 XXmg/kg, DL3 XXmg/kg. Starting dose is XX mg/kg. Each treatment cycle is 28 days, with 4 infusions on D1, D4, D7, D10; 1-2 cycles. The investigator may escalate to higher doses to further explore safety and efficacy of STR-P004 based on preliminary safety data, efficacy information, and PK/PD parameters obtained.

Detailed description

This is a single-center, non-randomized, open-label, single-arm exploratory clinical study, using Bayesian Optimal Interval (BOIN) design. Three dose groups are planned: DL1 XXmg/kg, DL2 XXmg/kg, DL3 XX mg/kg. Starting dose is XX mg/kg. Each treatment cycle is 28 days, with 4 infusions on D1, D4, D7, D10; 1-2 cycles. The investigator may escalate to higher doses to further explore safety and efficacy of STR-P004 based on preliminary safety data, efficacy information, and PK/PD parameters obtained. After dose escalation is completed, the investigator and collaborator may select 1 or 2 dose groups for an expansion cohort study (or during dose escalation). Each dose group will enroll an additional 3-6 subjects to evaluate efficacy and determine the RP2D. This study aims to determine the safety, tolerability, and RP2D of STR-P004 in subjects with immune-mediated kidney diseases. The study will also evaluate the PK characteristics of STR-P004 and provide preliminary efficacy observations

Conditions

• Autoimmune Diseases

Interventions

Type	Name	Description
DRUG	STR-P004 dose group	Three dose groups are planned: DL1 XXmg/kg, DL2 XXmg/kg, DL3 XX mg/kg. Starting dose is XX mg/kg.

Timeline

• Start date: 2026-02-02
• Primary completion: 2027-02-01
• Completion: 2028-02-01
• First posted: 2026-01-23
• Last updated: 2026-01-23