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

NCT05969236 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-07-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Shanghai Medinno Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Sepehr Shakib, PhD · CMAX Clinical Research

  • Liang Lu, PhD · Shanghai Medinno Pharmaceutical Technology Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-06
Primary Completion
2024-04-30
Completion
2024-05-30
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05969236 on ClinicalTrials.gov