Phase 1 Safety Study of ALK-001 in Healthy Volunteers

A Phase 1, Open Label, Repeat Dose Study to Investigate the Safety and Pharmacokinetics of 4-week Daily Dosing of ALK-001 in Healthy Volunteers

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.

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.