NCT06774664

A Clinical Study of SCTC21C in Participants With Plasma Cell-driven Autoimmune Diseases

A Randomized, Double-blind, Placebo-controlled Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SCTC21C in Subjects With Plasma Cell-driven Autoimmune Diseases

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Sinocelltech Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SCTC21C in subjects with plasma cell-driven autoimmune diseases

Detailed description

This is a randomized, double-blind, placebo-controlled Phase I/II study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of multiple doses of SCTC21C in subjects with plasma cell-driven autoimmune diseases. In phase 1 study, participants will be assigned to receive sequentially higher doses of SCTC21C to determine the recommended dose of SCTC21C for the randomized dose optimization- stage. In phase 2 study, 2 dose levels will be used. A total of 72 participants will be randomized in a 1:1:1 ration to dose 1, dose 2 or placebo groups to better understand the exposure/efficacy/toxicity relationship.

Conditions

• IgA Nephropathy

Interventions

Type	Name	Description
BIOLOGICAL	SCTC21C	Drug: SCTC21C Administered SC

Timeline

• Start date: 2025-01-01
• Primary completion: 2027-09-01
• Completion: 2029-03-01
• First posted: 2025-01-14
• Last updated: 2025-01-14

Locations

20 sites across 1 country: China