Safety and Tolerability of Retinoid QLT091001 in Healthy Volunteers

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

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Key information

Conditions

Healthy Human Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Toronto, Ontario, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

QLT091001

Drug

7-day repeated dose

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

Sponsors and collaborators

Lead sponsor

QLT Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Oct 3, 2008
Registry last updated: Mar 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed