Phase 1 Safety Study of ALK-001 in Healthy Volunteers

Phase 1

Completed

• Conditions: Stargardt Disease; Age-related Macular Degeneration; Other Retinal Dystrophies
• Interventions: Drug: ALK-001 (No generic name)

• Registration Number: NCT02230228
• Lead Sponsor: Alkeus Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-08-27
• Primary Completion: 2014-09
• Study First Submitted QC: 2014-09-02
• Study First Posted: 2014-09-03
• Study Completion: 2015-02
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALK-001 capsules	ALK-001 (No generic name)	-

Primary Outcome Measures

Name	Time	Method
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).