NCT05969236

A Study of MDI-1228_mesylate Ophthalmic Solution in Healthy Adults

A Phase 1, First-in-Human, Single-center, Randomized, Double-masked, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of MDI-1228_mesylate Ophthalmic Solution by Local Instillation in Adult Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Shanghai Medinno Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetics (PK) profiles\* of MDI-1228\_mesylate Ophthalmic Solution in healthy adult participants. Participants will receive either of the following treatment: * MDI-1228\_mesylate Ophthalmic Solution, or * Placebo\*\* Researchers will observe any changes in health (if any) in participants receiving the study treatment to evaluate the safety and tolerability\*\*\* of the study drug. Researchers will also collect several blood samples from participants to study PK profiles of the drug. Note: \*PK profiles: how the drug interacts with the body. \*\*placebo: a harmless substance that contains no active agents. \*\*\*tolerability: how well you can tolerate the drug.

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	MDI-1228_mesylate Ophthalmic Solution	MDI-1228\_mesylate Ophthalmic Solution includes 2 strengths: * 0.1% (0.4 mL \[0.4 mg\] free base) * 0.3% (0.4 mL \[1.2 mg\] free base)
DRUG	Placebo	The components employed in the placebo formulation are the same as those used for the active formulation except MDI-1228\_mesylate is absent.

Timeline

• Start date: 2023-10-06
• Primary completion: 2024-04-30
• Completion: 2024-05-30
• First posted: 2023-08-01
• Last updated: 2024-07-09

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study