NCT06067490

A Phase I Study of RC1416 Injection

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, andImmunogenicity of RC1416 Injection Via Subcutaneous Administration in Healthy Adult Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Nanjing RegeneCore Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a phase I study to evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of RC1416 injection via Subcutaneous Administration in Healthy Adult Volunteers.

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 48 healthy adult subjects will be enrolled in six groups to access the safety and tolerability of single subcutaneous injection of RC1416 in healthy adult subjects.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	RC1416(SAD)	RC1416(SAD),there are six doses(25mg-600mg) in this part. Each subjects will receive the drug once by subcutaneous injection.
DRUG	Placebo(SAD)	Placebo(SAD), Each subjects will receive the placebo once by subcutaneous injection.

Timeline

• Start date: 2023-06-29
• Primary completion: 2024-05-14
• Completion: 2024-05-14
• First posted: 2023-10-05
• Last updated: 2024-12-02

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study