AB1 in Adult Patients with Sickle Cell Disease (SCD)
NCT05261711 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2024-12-04
Summary
This will be an open-label, dose escalating study with a starting dose of 2mg. Up to 6 additional cohorts will be enrolled at subsequently higher doses of 4mg, 8mg, 10mg, 12mg, 16mg, and 32mg. In each dose escalation cohort, each dose will be taken orally, once daily, for 8 weeks.
Conditions
Interventions
- DRUG
-
AB1
This will be an open-label, dose escalating study with a starting dose of 2mg. Up to 6 additional cohorts will be enrolled at subsequently higher doses of 4mg, 8mg, 10 mg, 12 mg, 16mg, and 32mg. Each dose will be taken orally, once daily, for 8 weeks
Sponsors & Collaborators
-
Nirmish Shah
lead OTHER
Principal Investigators
-
Nirmish Shah, MD · Duke University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-05
- Primary Completion
- 2024-10-01
- Completion
- 2024-10-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
NCT04610866 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Study of ALXN1820 in Adult Participants With Sickle Cell Disease
NCT05565092 ·Status: TERMINATED ·Phase: PHASE2
-
A Phase 1b, Open-Label Study of DISC-3405 in Participants With Sickle Cell Disease (SCD)
NCT07187973 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of the Effect of IW-1701 (Olinciguat), a Stimulator of Soluble Guanylate Cyclase (sGC), on Patients With Sickle Cell Disease (SCD)
NCT03285178 ·Status: COMPLETED ·Phase: PHASE2
-
Dose Escalation Study of PF-07209326 in Healthy Participants and Participants With Sickle Cell Disease
NCT04255875 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Pharmacokinetic, and Pharmacodynamic Study of NKTT120 in Adult Patients With Stable Sickle Cell Disease (SCD)
NCT01783691 ·Status: COMPLETED ·Phase: PHASE1
-
Decitabine for High-Risk Sickle Cell Disease
NCT01375608 ·Status: COMPLETED ·Phase: PHASE2
-
Study of SANGUINATE™ In the Treatment of Sickle Cell Disease Patients With Vaso-Occlusive Crisis
NCT02411708 ·Status: COMPLETED ·Phase: PHASE2
-
Red Cell Half Life Determination in Patients With and Without Sickle Cell Disease
NCT04476277 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Oral GSK4172239D Compared With Placebo in Sickle Cell Disease Participants Aged 18 to 50 Years
NCT05660265 ·Status: TERMINATED ·Phase: PHASE1
-
US Phase I Study of ECT-001-CB in Patients With Sickle-Cell Disease
NCT04594031 ·Status: WITHDRAWN ·Phase: PHASE1
-
Assessment of Algorithm-Based Hydroxyurea Dosing on Fetal Hemoglobin Response, Acute Complications, and Organ Function in People With Sickle Cell Disease
NCT02225132 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Prospective, Observational Study in Sickle Cell Disease Patients on Crizanlizumab Treatment in Middle East Countries and India
NCT05020873 ·Status: TERMINATED
-
A Phase I/II Trial of Recombinant-Methionyl Human Stem Cell Factor (SCF) in Adult Patients With Sickling Disorders
NCT00005783 ·Status: COMPLETED ·Phase: PHASE1
-
Defibrotide in Sickle Cell Disease-Related Acute Chest Syndrome
NCT03805581 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
NCT06546670 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Adenosine 2A Agonist Lexiscan in Children and Adults With Sickle Cell Disease
NCT01085201 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-946 in Healthy Volunteers and in Participants With Sickle Cell Disease
NCT04536792 ·Status: COMPLETED ·Phase: PHASE1
-
Multicenter Study of Hydroxyurea in Patients With Sickle Cell Anemia (MSH)
NCT00000586 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
NCT05904093 ·Status: RECRUITING ·Phase: PHASE1
-
Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HQK-1001 Administered Daily in Patients With Sickle Cell Disease
NCT00842088 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease
NCT01054768 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Panobinostat (LBH589) in Patients With Sickle Cell Disease
NCT01245179 ·Status: RECRUITING ·Phase: PHASE1
-
Non-myeloablative Haploidentical HCT Study for Patients With Sickle Cell Disease, Including Compromised Organ Function
NCT06145282 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Evaluation of Different Dose Regimens of Aes-103 Given for 28 Days to Subjects With Stable Sickle Cell Disease
NCT01987908 ·Status: TERMINATED ·Phase: PHASE2