Status:
COMPLETED
Phase 1 Safety Study of ALK-001 in Healthy Volunteers
Lead Sponsor:
Alkeus Pharmaceuticals, Inc.
Conditions:
Stargardt Disease
Age-related Macular Degeneration
Eligibility:
All Genders
21-70 years
Phase:
PHASE1
Brief Summary
This protocol is a phase 1 clinical study to assess the safety and pharmacokinetics of ALK-001 in healthy volunteers. Please contact trials@alkeus.com for any questions.
Eligibility Criteria
Inclusion
- Main Inclusion Criteria
- Adult between 21 and 70 years old (inclusive)
- Healthy subject, as judged by investigator
- Subject is able and willing to comply with study requirements (study medication compliance, schedule of follow-up visits)
- Subject has provided informed consent to participate
- If female, subject uses a medically accepted birth control method and agrees to use such a method for entire clinical trial period
- Main Exclusion Criteria:
- Subject has taken disallowed items during the past 30 days
- Female with a positive urine pregnancy test at screening
- Lactating woman
- Subject has participated in any clinical study involving an investigational drug, biologic or device, during the past 30 days
- History or current evidence of gastrointestinal malabsorption
- Subject has any other medical condition, which in the opinion of the investigator, is likely to prevent compliance with protocol and/or interfere with successful collection of study
- Subject has, in the opinion of investigator, clinically significant laboratory result(s), positive drug or alcohol screening, or ECG, which makes subject unsuitable for participation.
Exclusion
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02230228
Start Date
April 1 2014
End Date
February 1 2015
Last Update
April 27 2025
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