Phase 1 Safety Study of ALK-001 in Healthy Volunteers

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This protocol is a phase 1 clinical study to assess the safety and pharmacokinetics of ALK-001 in healthy volunteers. Please contact[email protected]for any questions.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alkeus Pharmaceuticals, Inc.
• Treatments: Retinol acetate; Vitamin A

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.