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
A Phase 1, Placebo-Controlled, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating, Single Oral Doses of Aes-103 in Subjects With Stable Sickle Cell Disease
Sponsor: Baxalta now part of Shire
This PHASE1 trial investigates Sickle Cell Disease and is currently completed. Baxalta now part of Shire leads this study, which shows 10 recorded versions since 2012 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
10 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE1
-
Sep 2024 — Present [monthly]
Completed PHASE1
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
-
Jun 2021 — Jul 2024 [monthly]
Completed PHASE1
-
Jan 2021 — Jun 2021 [monthly]
Completed PHASE1
▶ Show 5 earlier versions
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE1
-
Jan 2018 — Jun 2018 [monthly]
Completed PHASE1
-
Nov 2017 — Jan 2018 [monthly]
Completed PHASE1
-
Feb 2017 — Nov 2017 [monthly]
Completed PHASE1
-
Jan 2017 — Feb 2017 [monthly]
Completed PHASE1
First recorded
May 2012
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Baxalta now part of Shire
- Cato Research
- ClinPharm Consulting, LLC
- Infrared Imaging and Thermometry Unit, Biomedical Engineering and Physical Science Shared Resource (NIBIB)
- National Chung Cheng University
- National Heart, Lung, and Blood Institute (NHLBI)
- QS Pharma
- Ricerca Biosciences LLC
- SAIC-Frederick, Inc.
- Therapeutics for Rare and Neglected Diseases (TRND)
For direct contact, visit the study record on ClinicalTrials.gov .