Phase 1 Safety Study of ALK-001 in Healthy Volunteers

April 24, 2025 updated by: Alkeus Pharmaceuticals, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALK-001 capsules
Drug: ALK-001 (No generic name)
Daily, oral administration of ALK-001 capsules.
Other Names:
  • C20-D3-Retinyl Acetate
  • C20 Deuterated vitamin A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of 4-week daily dosing of ALK-001 in healthy adults.
Time Frame: 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).
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alkeus Pharmaceuticals, Inc.

Investigators

  • Study Director: Leonide Saad, PhD, Alkeus Pharmaceuticals, Inc.
  • Study Chair: Ilyas Washington, PhD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

August 27, 2014

First Submitted That Met QC Criteria

September 2, 2014

First Posted (Estimated)

September 3, 2014

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALK001-P1001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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