Phase 1 Safety Study of ALK-001 in Healthy Volunteers

Alkeus Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Other Retinal Dystrophies

Stargardt Disease

Age-related Macular Degeneration

Treatments

Drug: ALK-001 (No generic name)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02230228

ALK001-P1001

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

21 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.