A Single Dose Study of the Safety, Blood Levels and Biological Effects of Aes-103 Compared to Placebo in Subjects With Stable Sickle Cell Disease

PHASE1CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

May 12, 2012

Primary Completion Date

June 7, 2013

Study Completion Date

June 7, 2013

Conditions
Sickle Cell Disease
Interventions
DRUG

Aes-103

300 mg Aes-103 powder reconstituted in orange juice to a volume of 100 mL per single dose for oral administration.

DRUG

Aes-103

1000 mg Aes-103 powder reconstituted in orange juice to a volume of 100 mL per single dose for oral administration.

DRUG

Aes-103

2000 mg Aes-103 powder reconstituted in orange juice to a volume of 100 mL per single dose for oral administration.

DRUG

Aes-103

4000 mg Aes-103 powder reconstituted in orange juice to a volume of 100 mL per single dose for oral administration.

DRUG

Placebo

Orange juice vehicle, a solution that is highly similar in appearance to the Aes-103 orange juice solution.

Trial Locations (1)

20892

US National Institutes of Health - National Heart, Lung, and Blood Institute, Bethesda

All Listed Sponsors
collaborator

SAIC-Frederick, Inc.

INDUSTRY

collaborator

Therapeutics for Rare and Neglected Diseases (TRND)

NIH

collaborator

QS Pharma

UNKNOWN

collaborator

National Chung Cheng University

OTHER

collaborator

Infrared Imaging and Thermometry Unit, Biomedical Engineering and Physical Science Shared Resource (NIBIB)

UNKNOWN

collaborator

ClinPharm Consulting, LLC

UNKNOWN

collaborator

Ricerca Biosciences LLC

UNKNOWN

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

Cato Research

INDUSTRY

lead

Baxalta now part of Shire

INDUSTRY