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

NCT07363954 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-01-23

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Starna Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-02-02
Primary Completion
2027-02-01
Completion
2028-02-01

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Entities

Diseases

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 NCT07363954 on ClinicalTrials.gov