NCT07403487

Phase II Trial of RC1416 Injection in Asthma

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of RC1416 Injection in Adult Patients With Moderate to Severe Asthma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 195 (estimated)
• Sponsor: Nanjing RegeneCore Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase II study of RC1416 in subjects with severe uncontrolled asthma. The purpose of the study is to evaluate efficacy and safety of RC1416 in subjects with severe uncontrolled asthma.

Detailed description

RC1416 is a bispecific homodimer nanobody .It is being developed by Nanjing RegeneCore Biotech Co., Ltd. as a potential therapy for asthma. A total 195 severe uncontrolled asthma subjects will be enrolled in three groups to access the efficacy and safety of RC1416.

Conditions

• Moderate to Severe Asthma

Interventions

Type	Name	Description
DRUG	RC1416	There are two doses in this part. Each subjects will receive the drug by subcutaneous injection.
DRUG	RC1416 Placebo	Each subjects will receive the placebo by subcutaneous injection

Timeline

• Start date: 2026-03-10
• Primary completion: 2027-10-25
• Completion: 2028-02-28
• First posted: 2026-02-11
• Last updated: 2026-02-11

Locations

45 sites across 1 country: China

Regulatory

• FDA-regulated drug study