Tolerability, Safety and Efficacy of SAD448 in Subjects With Ocular Hypertension

A Multicenter, Randomized, Placebo-Controlled, Double-Masked, 4-Arm Parallel Group Study to Assess the Tolerability, Safety and Efficacy of Two Doses of SAD448 in Subjects With Ocular Hypertension

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00503360

Enrollment

Registered

2007-07-18

Start date

2007-04-30

Completion date

Unknown

Last updated

2008-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Hypertension

Keywords

Ocular Hypertension, SAD448

Brief summary

This study will evaluate the tolerability and safety of SAD448 and explore the compound's effect on intraocular pressure in subjects with ocular hypertension.

Interventions

DRUGSAD448

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Inclusion criteria

Key inclusion criteria: * Males and females, 18 - 65 years of age, with ocular hypertension * Females must be post-menopausal or surgically sterile Key

Exclusion criteria

* Diagnosis of glaucoma in either eye * A history of or current eye conditions or medical problems that would prohibit the use of an investigational drug

Design outcomes

Primary

Measure	Time frame
Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, ECGs and vital signs from baseline up to 24 hours post-dosing.	—

Secondary

Measure	Time frame
Change in ocular hypertension from baseline up to 24 hours post-dosing. Systemic exposure to SAD448 following the administration of two doses.	—

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026