Safety and Tolerability of Retinoid QLT091001 in Healthy Volunteers

Phase 1CompletedNCT00765427

QLT Inc.18 enrolled

Overview

Healthy volunteer subjects will receive retinoid QLT091001 once-daily for 7 days for safety observation.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Healthy Human Volunteers

Interventions

QLT091001DRUG

7-day repeated dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy subjects with ECG within normal limits and normal blood pressure and resting heart rate Exclusion Criteria: * Subjects with any clinically important abnormal physical finding at screening. * Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 60 days of baseline. * Female subjects who are either pregnant or lactating.

Locations (1)

Unnamed facility

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Clinical laboratory tests, ECG, vital signs, color vision, and visual acuity

Time frame: 30 days

Secondary Outcomes

Adverse events

Time frame: 30 days

Data from ClinicalTrials.gov

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