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NOT YET RECRUITING
NCT07363954
NA

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

Sponsor: Starna Therapeutics

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2026-02-02

Completion Date

2028-02-01

Last Updated

2026-01-23

Healthy Volunteers

No

Interventions

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.