Age-related Macular Degeneration, Other Retinal Dystrophies, Stargardt Disease
Conditions
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.
Interventions
DRUGALK-001 (No generic name)
Daily, oral administration of ALK-001 capsules.
Sponsors
Alkeus Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of 4-week daily dosing of ALK-001 in healthy adults. | 4 weeks | Safety evaluations combine: adverse events (AE), laboratory testing (hematology and biochemistry panels), 12-lead electrocardiograms (ECGs), vital signs, physical examination, and visual function (visual acuity and a self-reported questionnaire). |
Outcome results
None listed