Healthy Human Volunteers Clinical Trial
Official title:
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
Verified date | March 2009 |
Source | QLT Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
Healthy volunteer subjects will receive retinoid QLT091001 once-daily for 7 days for safety observation.
Status | Completed |
Enrollment | 18 |
Est. completion date | March 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
QLT Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical laboratory tests, ECG, vital signs, color vision, and visual acuity | 30 days | Yes | |
Secondary | Adverse events | 30 days | Yes |
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