NCT06911866

A Phase Ib Study of RC1416 Injection

A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Efficacy of RC1416 Injection in Patients With Moderate to Severe Asthma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Nanjing RegeneCore Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RC1416 injection in patients with moderate to severe asthma.

Detailed description

This study is a randomized, double-blind, placebo-controlled, ascending dose Phase Ib clinical study. RC1416 is a bispecific antibodies .It is being developed by Nanjing RegeneCore Biotech Co., Ltd. as a potential therapy for asthma. A total 40 patients with moderate to severe asthma will be enrolled in 4 groups to access the safety, tolerability, PK, PD, immunogenicity and preliminary efficacy of RC1416 injection.

Conditions

• Moderate to Severe Asthma

Interventions

Type	Name	Description
DRUG	RC1416	there are four doses(200mg-400mg) in this part. Each subjects will receive the drug once by subcutaneous injection.
DRUG	RC1416 Placebo	Each subjects will receive the placebo once by subcutaneous injection.

Timeline

• Start date: 2024-10-25
• Primary completion: 2025-09-25
• Completion: 2025-09-25
• First posted: 2025-04-04
• Last updated: 2026-01-30

Locations

16 sites across 1 country: China

Regulatory

• FDA-regulated drug study