NCT07521748

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of RC017 Ophthalmic Ointment Following Single and Multiple Doses in Healthy Adult Participants

A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of RC017 Ophthalmic Ointment Following Single and Multiple Doses in Healthy Adult Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Nanjing Reju Therapeutics Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of RC017 Ophthalmic Ointment Following Single and Multiple Doses in Healthy Adult Participants.RC017 is a small-molecule drug, being developed as a novel therapeutic treatment for patients with Dry Eye Disease (DED) . This study aims to evaluate the safety, tolerability and pharmacokinetics of RC017 after Single and Multiple Doses.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	RC017 Ophthalmic Ointment	Participants were randomly assigned to the 3 dose groups
DRUG	RC017 Ophthalmic Ointment placebo	Match to RC017 Ophthalmic Ointment dose groups

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-12-01
• Completion: 2027-04-01
• First posted: 2026-04-13
• Last updated: 2026-04-13

Regulatory

• FDA-regulated drug study