NCT00765427CompletedPhase 1
A Phase 1a, Repeat-Dose Escalation Study to Investigate the Safety and Tolerability of a 7-Day Repeated Dose of Retinoid QLT091001 in Healthy Volunteers
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- QLT Inc.
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Clinical laboratory tests, ECG, vital signs, color vision, and visual acuity
Study Overview
Brief Summary
Healthy volunteer subjects will receive retinoid QLT091001 once-daily for 7 days for safety observation.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Clinical laboratory tests, ECG, vital signs, color vision, and visual acuity
Time Frame: 30 days
Secondary Outcomes
- Adverse events(30 days)
Investigators
Study Sites (1)
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