Safety and Tolerability of Retinoid QLT091001 in Healthy Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00765427

Enrollment

Registered

2008-10-03

Start date

2008-09-30

Completion date

2009-03-31

Last updated

2009-03-30

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

Conditions

Healthy Human Volunteers

Brief summary

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

Interventions

DRUGQLT091001

7-day repeated dose

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame
Clinical laboratory tests, ECG, vital signs, color vision, and visual acuity	30 days

Secondary

Measure	Time frame
Adverse events	30 days

Countries

Canada

Outcome results

None listed

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