Sickle Cell Disease, Hemolytic AnemiaPhase 1NCT07566494
Escalating Doses of VAS-101 in Subjects With Stable Sickle Cell Disease
A Phase 1 study testing VAS-101 in people with Sickle Cell Disease, Hemolytic Anemia, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Background: Sickle cell disease (SCD) is an inherited blood disorder. The disease affects the ability of red blood cells to carry oxygen. Research has shown that curcumin, a natural compound found in turmeric, can improve the health of red blood cells in people with SCD. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sickle Cell Disease, Hemolytic Anemia
- What is being tested?
- VAS-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2026to 27 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will enroll onto the study and undergo screening. Subjects who do not meet any of the following criteria during screening will not receive the study intervention but will be counted toward study accrual. Screen failures may be rescreened at a later time. In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Have provided signed written informed consent prior to performing any study procedure, including screening procedures.
- Age between 18-70 years. Adults over 70 years of age will be excluded from this study due to an increased risk of more severe disease and higher prevalence of multiple comobodities.
- Unequivocal diagnosis of SCD (HbSS, HbSC, HbSbeta+ or HbSbeta^0) confirmed by hemoglobin electrophoresis performed on patients at least 60 days after a blood transfusion if previously transfused.
- No transfusion in the 60 days prior to signing consent, or absence of Hb A on hemoglobin analysis (by high-performance liquid chromatography; HPLC)
- Serum aspartate aminotransferase (AST) <= 1.5 x Upper Limit of Normal (ULN) (unless the increased AST is assessed by the Investigator as due to hemolysis) and alanine aminotransferase (ALT) <=1.5 x ULN.
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- Hemoglobin >= 7 g/dL
- Serum creatinine <=1.25 x ULN. If serum creatinine is >1.25 x ULN, then glomerular filtration rate (based on creatinine) must be >=60 mL/min.
- If on hydroxyurea, participant must have been on stable dose of hydroxyurea (defined as a stable dose for at least 90 days and inclusive of dose modifications for hematological toxicity per PI discretion) prior to signing consent.
- If on L-glutamine and/or crizanlizumab, participant must have been on a stable dose for ast least 90 days prior to signing consent.
- Agree to abstain from taking any other products/supplements containing turmeric or curcumin until all study visits have been completed (oral, topical, etc.)
- For women of reproductive potential, have a negative serum pregnancy test during the screening period. Women of reproductive potential are defined as sexually mature women who have not undergone a hysterectomy, bilateral oophorectomy, or tubal occlusion; or who have not been naturally postmenopausal (i.e., who have not menstruated at all for at least the preceding 1 year prior to signing informed consent unrelated to hormonal contraception).
- Women of reproductive potential be abstinent as part of their usual lifestyle, or agree to use 2 effective forms of contraception from the time of giving informed consent, during the study, and for 28 days following the last dose of study treatment. An effective form of contraception is defined as hormonal oral contraceptives, injectables, patches, intrauterine or subdermal contraceptive implants, and barrier methods.
- Be willing to comply with all study procedures for the duration of the study.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Vaso-occlusive crisis requiring parenteral treatment within 14 days of signing consent.
- Three or more vaso-occlusive crises in the 12 months prior to screening that resulted in receiving treatment in an urgent care, outpatient infusion center/day-clinic, emergency department or inpatient setting.
- Have a significant medical condition that confers an unacceptable risk to participating in the study, and/or that could confound the interpretation of the study data. Such significant medical conditions include, but are not limited to the following:
- Poorly controlled hypertension (defined as systolic blood pressure [BP] >150 mmHg or diastolic BP >90 mmHg) refractory to medical management.
- History of recent (within 24 weeks prior to signing consent) decompensated congestive heart failure; myocardial infarction or unstable angina pectoris; hemorrhagic, embolic, or thrombotic stroke; deep venous thrombosis; or pulmonary or arterial embolism.
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- Clinically symptomatic cholelithiasis or cholecystitis. Prior cholecystectomy is not exclusionary. Subjects with symptomatic cholelithiasis or cholecystitis may be rescreened once the disorder has been treated and clinical symptoms have resolved.
- History of drug-induced cholestatic hepatitis.
- Iron overload sufficiently severe to result in a clinical diagnosis by the Investigator of cardiac (e.g., clinically significant impaired left ventricular ejection fraction), hepatic (e.g., fibrosis, cirrhosis), or pancreatic (e.g., diabetes) dysfunction.
- Positive test for hepatitis B surface antigen or hepatitis C virus (HCV) antibody (Ab) with signs of active hepatitis B or C virus infection. If the subject is positive for HCVAb, a reverse transcriptase-polymerase chain reaction test will be conducted. Subjects with hepatitis C may be rescreened after receiving appropriate hepatitis C treatment.
- Active infection requiring any use of systemic antimicrobial agents (parenteral or oral) or Grade >=3 in severity (per National Cancer Institute Common Terminology Criteria for Adverse Events) within 4 weeks prior to signing consent.
- Diabetes mellitus judged to be under poor control by the Investigator or requiring >3 antidiabetic agents, including insulin (all insulins are considered 1 agent); use of insulin per se is not exclusionary.
- History of any primary malignancy, with the exception of: curatively treated nonmelanomatous skin cancer; curatively treated cervical or breast carcinoma in situ; or other primary tumor treated with curative intent, no known active disease present, and no treatment administered during the last 3 years.
- Current or recent history of psychiatric disorder that, in the opinion of the Investigator or Medical Monitor, could compromise the ability of the subject to cooperate with study visits and procedures.
- Have had a prior bone marrow or stem cell transplant.
- Are currently enrolled in another therapeutic clinical trial involving ongoing therapy with any investigational or marketed product or placebo.
- Taking nitroglycerin, or any other nitrate-enhancing drug.
- Have exposure to any investigational drug, device, or invasive procedure within 12 weeks prior to signing consent. All non-investigational invasive procedures within 12 weeks of signing consent may be considered as a potential exclusion criteria per the PI's discretion.
- Currently pregnant or breastfeeding.
- Currently receiving hematopoietic stimulating agents (e.g., erythropoietins, granulocyte colony stimulating factors, thrombopoietins) that have not been stopped for a duration of at least 90 days prior to signing consent.
- Have a history of allergy to turmeric, curcuminoids, or formulations thereof.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: A Phase 1 Study to Evaluate the Safety and Tolerability of Escalating Doses of VAS-101 in Subjects With Stable Sickle Cell Disease
Background:
Sickle cell disease (SCD) is an inherited blood disorder. The disease affects the ability of red blood cells to carry oxygen. Research has shown that curcumin, a natural compound found in turmeric, can improve the health of red blood cells in people with SCD. But the body cannot absorb curcumin well when it is taken by mouth. Researchers want to know if a skin gel (VAS-101) can help the body better absorb curcumin. VAS-101 contains curcumin, which comes from turmeric.
Read more
Objective:
To test VAS-101 in people with stable SCD.
Eligibility:
People aged 18 to 70 years with stable SCD.
Design:
People who want to join the study will be screened with physical exam with blood tests to see if they are eligible. If they qualify, they can enroll in the study.
Participants will have up to 15 clinic visits over about 14 weeks. Some may need to stay overnight in the hospital for up to 2 days to make it easier to collect blood samples after the gel is applied.
For 6 weeks, a special gel called VAS-101 will be put on the forearms in the clinic two times a week. Staff will rub the gel into the skin for at least 30 seconds using a soft toothbrush. The area stays uncovered for at least 10 minutes, then is covered with a bandage or sleeve. After 24 hours, the dressing can be removed and the skin can be washed.
Some visits will include blood tests and other exams. On three visits, a test called near infrared spectroscopy (NIRS) will be done. For this test, probes are placed on the skin to measure blood flow, oxygen levels, and the makeup of skin and muscle. A blood pressure cuff is used to squeeze the arm for up to 5 minutes.
The last clinic visit will happen about 4 weeks after the final gel application....
Read the detailed description
Study Description:
The overall objective of this study is to assess the clinical safety and tolerability of a patented, bioavailability-enhanced, transdermal application of curcuminoids, VAS-101 / Vasceptor(R) (8.5% curcuminoids transdermal gel), in subjects with stable sickle cell disease (SCD). VAS-101 contains Curcugen(R) as the active ingredient, with concentrations of 2mg in VAS-101 0.05 mL, 4mg in VAS-101 0.1 mL, and 12mg in VAS-101 0.3 mL. Subjects enrolled will receive 0.2 mL of VAS-101 topically twice weekly for two weeks, followed by 0.4 mL twice weekly for two weeks, then 0.6mL twice weekly for two weeks. Throughout the course of the study, subjects will be monitored for signs and symptoms of adverse events. The effect of VAS-101 on laboratory biomarkers of inflammatory activity, red cell metabolism and deformability will also be studied at specific timepoints.
Objectives:
Primary Objective:
To assess the clinical safety and tolerability of escalating doses of a patented, bioavailability-enhanced, transdermal application of curcuminoids, VAS-101 / Vasceptor(R) (8.5% curcuminoids transdermal gel), in adult patients with stable SCD.
Secondary Objectives:
To assess the pharmacokinetics of VAS-101 in SCD and correlate drug exposure to anti-inflammatory and anti-sickling effects at different dose levels.
Tertiary/Exploratory Objectives:
To explore effects of VAS-101 on neutrophil and platelet function, red cell and monocyte metabolism, and muscle physiology.
Endpoints:
Primary Endpoints:
- To evaluate the safety and tolerability of VAS-101 as assessed by: --The type, incidence, severity, and relationship to study treatment of AEs and serious adverse events (SAEs) from Baseline to Day 66, including:
- Number of most common treatment related adverse events
- Number of serious adverse events possibly related to treatment
- Number of discontinuations due to AEs from Baseline to Day 66
- Mean change in clinical laboratory test results (e.g., serum chemistry, liver function test, hematology, coagulation) from baseline at each dose level (days 0, 14, 28, 42 and 66).
Secondary Endpoints:
- Percentage of sickled cells, time to 50 percent sickling (t50) and area under sickling curve under hypoxic ex vivo conditions at regular time intervals (days 0, 14, 28, 42 and 66).
- Percentage change in oxygen affinity (p50) at regular time intervals (days 0, 14, 28, 42 and 66).
- Change in intracellular reactive oxidative species (ROS) in RBCs at regular time intervals (days 0, 14, 28, 42 and 66).
- Change in markers of inflammation, adhesion and coagulation activation at regular time intervals (days 0, 14, 28, 42 and 66).
Tertiary/Exploratory Endpoints:
- Proteomic, metabolomic and lipidomic studies to evaluate the effect of VAS-101 on RBCs and monocytes at regular time intervals (days 0, 14, 28, 42 and 66).
- Evaluate effect of VAS-101 on RBC band 3 tyrosine phosphorylation at regular time intervals (days 0, 14, 28, 42 and 66).
- Assessment of muscle physiology, tissue oxygenation and blood flow using near infrared spectroscopy (NIRS) methodologies at regular time intervals (days 0, 42 and 66).
- Evaluate effect of VAS-101 on neutrophil activation and neutrophil extracellular trap (NET) formation at baseline and regular time intervals (days 0, 14, 28, 42 and 66).
- Studies of extracellular vesicles (EVs) at regular time intervals (days 0, 14, 28, 42 and 66).
- Conditions
- Sickle Cell Disease, Hemolytic Anemia
- Being tested
- VAS-101
- Medical subject headings
- Anemia, Sickle Cell, Anemia, Hemolytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAS-101Drug
VAS-101 contains Curcugen (Registered Trademark) as the active ingredient, with concentrations of 2mg in VAS-101 0.05 mL, 4mg in VAS-101 0.1 mL, and 12mg in VAS-101 0.3 mL
| Study group | Role | What they receive |
|---|---|---|
| VAS-101 | Experimental | VAS-101 contains Curcugen (Registered Trademark) as the active ingredient, with concentrations of 2mg in VAS-101 0.05 mL, 4mg in VAS-101 0.1 mL, and 12mg in VAS-101 0.3 mL Receives: Drug: VAS-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the clinical safety and tolerability of escalating doses of a patented, bioavailability-enhanced, transdermal application of curcuminoids, VAS-101 / Vasceptor (8.5% curcuminoids transdermal gel), in adult patients with stable SCD.
-To evaluate the safety and tolerability of VAS-101 as assessed by:-The type, incidence, severity, and relationship to study treatment of AEs and serious adverse events (SAEs) from Baseline to Day 66, including:-Number of most common treatment related adverse events-Number of serious adverse events possibly related to treatment-Number of discontinuations due to AEs from Baseline to Day 66-Mean change in clinical laboratory test results (e.g., serum chemistry, liver function test, hematology, coagulation) from baseline at each dose level (days 0, 14, 28, 42 \& 66).
Measured: Baseline to Day 66
Secondary outcomes (1)
To assess the pharmacokinetics of VAS-101 in SCD and correlate drug exposure to anti-inflammatory and anti-sickling effects at different dose levels.
Percentage of sickled cells, time to 50% sickling (t50) and area under sickling curve under hypoxic ex vivo conditions at regular time intervals (days 0, 14, 28, 42 and 66).Percentage change in oxygen affinity (p50) at regular time intervals (days 0, 14, 28, 42 and 66).Change in intracellular reactive oxidative species (ROS) in RBCs at regular time intervals (days 0, 14, 28, 42 and 66). Change in markers of inflammation, adhesion and coagulation activation at regular time intervals (days 0, 14, 28, 42 and 66).
Measured: days 0, 14, 28, 42 & 66
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start31 Jul 2026
- Primary completion27 Apr 2027 (estimated)
- Study completion27 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell Disease, Hemolytic AnemiaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Swee Lay Thein, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566494
- Sponsor's protocol ID
- 10002508
- Other IDs
- 002508-H
- Status last verified
- 19 Oct 2026
- First submitted
- 2 May 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
GBD 2021 Sickle Cell Disease Collaborators. Global, regional, and national prevalence and mortality burden of sickle cell disease, 2000-2021: a systematic analysis from the Global Burden of Disease Study 2021. Lancet Haematol. 2023 Aug;10(8):e585-e599. doi: 10.1016/S2352-3026(23)00118-7. Epub 2023 Jun 15.
PubMed 37331373Hassell KL. Population estimates of sickle cell disease in the U.S. Am J Prev Med. 2010 Apr;38(4 Suppl):S512-21. doi: 10.1016/j.amepre.2009.12.022.
PubMed 20331952
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety and Tolerability of Escalating Doses of VAS-101 in Subjects With Stable Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT07566494
- Acronym / sponsor ID
- 10002508
- Conditions
- Sickle Cell Disease, Hemolytic Anemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- 27 Apr 2027 (estimated)
- Study completion
- 27 Apr 2027 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Sickle cell disease (SCD) is an inherited blood disorder. The disease affects the ability of red blood cells to carry oxygen. Research has shown that curcumin, a natural compound found in turmeric, can improve the health of red blood cells in people with SCD. But the body cannot absorb curcumin well when it is taken by mouth. Researchers want to know if a skin gel (VAS-101) can help the body better absorb curcumin. VAS-101 contains curcumin, which comes from turmeric.
Objective:
To test VAS-101 in people with stable SCD.
Eligibility:
People aged 18 to 70 years with stable SCD.
Design:
People who want to join the study will be screened with physical exam with blood tests to see if they are eligible. If they qualify, they can enroll in the study.
Participants will have up to 15 clinic visits over about 14 weeks. Some may need to stay overnight in the hospital for up to 2 days to make it easier to collect blood samples after the gel is applied.
For 6 weeks, a special gel called VAS-101 will be put on the forearms in the clinic two times a week. Staff will rub the gel into the skin for at least 30 seconds using a soft toothbrush. The area stays uncovered for at least 10 minutes, then is covered with a bandage or sleeve. After 24 hours, the dressing can be removed and the skin can be washed.
Some visits will include blood tests and other exams. On three visits, a test called near infrared spectroscopy (NIRS) will be done. For this test, probes are placed on the skin to measure blood flow, oxygen levels, and the makeup of skin and muscle. A blood pressure cuff is used to squeeze the arm for up to 5 minutes.
The last clinic visit will happen about 4 weeks after the final gel application....
Detailed description
Study Description:
The overall objective of this study is to assess the clinical safety and tolerability of a patented, bioavailability-enhanced, transdermal application of curcuminoids, VAS-101 / Vasceptor(R) (8.5% curcuminoids transdermal gel), in subjects with stable sickle cell disease (SCD). VAS-101 contains Curcugen(R) as the active ingredient, with concentrations of 2mg in VAS-101 0.05 mL, 4mg in VAS-101 0.1 mL, and 12mg in VAS-101 0.3 mL. Subjects enrolled will receive 0.2 mL of VAS-101 topically twice weekly for two weeks, followed by 0.4 mL twice weekly for two weeks, then 0.6mL twice weekly for two weeks. Throughout the course of the study, subjects will be monitored for signs and symptoms of adverse events. The effect of VAS-101 on laboratory biomarkers of inflammatory activity, red cell metabolism and deformability will also be studied at specific timepoints.
Objectives:
Primary Objective:
To assess the clinical safety and tolerability of escalating doses of a patented, bioavailability-enhanced, transdermal application of curcuminoids, VAS-101 / Vasceptor(R) (8.5% curcuminoids transdermal gel), in adult patients with stable SCD.
Secondary Objectives:
To assess the pharmacokinetics of VAS-101 in SCD and correlate drug exposure to anti-inflammatory and anti-sickling effects at different dose levels.
Tertiary/Exploratory Objectives:
To explore effects of VAS-101 on neutrophil and platelet function, red cell and monocyte metabolism, and muscle physiology.
Endpoints:
Primary Endpoints:
- To evaluate the safety and tolerability of VAS-101 as assessed by: --The type, incidence, severity, and relationship to study treatment of AEs and serious adverse events (SAEs) from Baseline to Day 66, including:
- Number of most common treatment related adverse events
- Number of serious adverse events possibly related to treatment
- Number of discontinuations due to AEs from Baseline to Day 66
- Mean change in clinical laboratory test results (e.g., serum chemistry, liver function test, hematology, coagulation) from baseline at each dose level (days 0, 14, 28, 42 and 66).
Secondary Endpoints:
- Percentage of sickled cells, time to 50 percent sickling (t50) and area under sickling curve under hypoxic ex vivo conditions at regular time intervals (days 0, 14, 28, 42 and 66).
- Percentage change in oxygen affinity (p50) at regular time intervals (days 0, 14, 28, 42 and 66).
- Change in intracellular reactive oxidative species (ROS) in RBCs at regular time intervals (days 0, 14, 28, 42 and 66).
- Change in markers of inflammation, adhesion and coagulation activation at regular time intervals (days 0, 14, 28, 42 and 66).
Tertiary/Exploratory Endpoints:
- Proteomic, metabolomic and lipidomic studies to evaluate the effect of VAS-101 on RBCs and monocytes at regular time intervals (days 0, 14, 28, 42 and 66).
- Evaluate effect of VAS-101 on RBC band 3 tyrosine phosphorylation at regular time intervals (days 0, 14, 28, 42 and 66).
- Assessment of muscle physiology, tissue oxygenation and blood flow using near infrared spectroscopy (NIRS) methodologies at regular time intervals (days 0, 42 and 66).
- Evaluate effect of VAS-101 on neutrophil activation and neutrophil extracellular trap (NET) formation at baseline and regular time intervals (days 0, 14, 28, 42 and 66).
- Studies of extracellular vesicles (EVs) at regular time intervals (days 0, 14, 28, 42 and 66).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VAS-101 | Experimental | Drug: VAS-101VAS-101 contains Curcugen (Registered Trademark) as the active ingredient, with concentrations of 2mg in VAS-101 0.05 mL, 4mg in VAS-101 0.1 mL, and 12mg in VAS-101 0.3 mL |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects will enroll onto the study and undergo screening. Subjects who do not meet any of the following criteria during screening will not receive the study intervention but will be counted toward study accrual. Screen failures may be rescreened at a later time. In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Have provided signed written informed consent prior to performing any study procedure, including screening procedures.
- Age between 18-70 years. Adults over 70 years of age will be excluded from this study due to an increased risk of more severe disease and higher prevalence of multiple comobodities.
- Unequivocal diagnosis of SCD (HbSS, HbSC, HbSbeta+ or HbSbeta^0) confirmed by hemoglobin electrophoresis performed on patients at least 60 days after a blood transfusion if previously transfused.
- No transfusion in the 60 days prior to signing consent, or absence of Hb A on hemoglobin analysis (by high-performance liquid chromatography; HPLC)
Key exclusion criteria (21 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Vaso-occlusive crisis requiring parenteral treatment within 14 days of signing consent.
- Three or more vaso-occlusive crises in the 12 months prior to screening that resulted in receiving treatment in an urgent care, outpatient infusion center/day-clinic, emergency department or inpatient setting.
- Have a significant medical condition that confers an unacceptable risk to participating in the study, and/or that could confound the interpretation of the study data. Such significant medical conditions include, but are not limited to the following:
- Are currently enrolled in another therapeutic clinical trial involving ongoing therapy with any investigational or marketed product or placebo.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VAS-101VAS-101 contains Curcugen (Registered Trademark) as the active ingredient, with concentrations of 2mg in VAS-101 0.05 mL, 4mg in VAS-101 0.1 mL, and 12mg in VAS-101 0.3 mL | Drug | VAS-101 |
Primary outcome
To assess the clinical safety and tolerability of escalating doses of a patented, bioavailability-enhanced, transdermal application of curcuminoids, VAS-101 / Vasceptor (8.5% curcuminoids transdermal gel), in adult patients with stable SCD.
Time frame: Baseline to Day 66
-To evaluate the safety and tolerability of VAS-101 as assessed by:-The type, incidence, severity, and relationship to study treatment of AEs and serious adverse events (SAEs) from Baseline to Day 66, including:-Number of most common treatment related adverse events-Number of serious adverse events possibly related to treatment-Number of discontinuations due to AEs from Baseline to Day 66-Mean change in clinical laboratory test results (e.g., serum chemistry, liver function test, hematology, coagulation) from baseline at each dose level (days 0, 14, 28, 42 \& 66).
1 secondary outcome
To assess the pharmacokinetics of VAS-101 in SCD and correlate drug exposure to anti-inflammatory and anti-sickling effects at different dose levels.
Time frame: days 0, 14, 28, 42 & 66
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 37331373GBD 2021 Sickle Cell Disease Collaborators. Global, regional, and national prevalence and mortality burden of sickle cell disease, 2000-2021: a systematic analysis from the Global Burden of Disease Study 2021. Lancet Haematol. 2023 Aug;10(8):e585-e599. doi: 10.1016/S2352-3026(23)00118-7. Epub 2023 Jun 15.
- Background: PubMed 20331952Hassell KL. Population estimates of sickle cell disease in the U.S. Am J Prev Med. 2010 Apr;38(4 Suppl):S512-21. doi: 10.1016/j.amepre.2009.12.022.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Swee Lay Thein, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VAS-101 in people with Sickle Cell Disease, Hemolytic Anemia, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jordan B Branch ((301) 221-3820, jordan.branch@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the clinical safety and tolerability of escalating doses of a patented, bioavailability-enhanced, transdermal application of curcuminoids, VAS-101 / Vasceptor (8.5% curcuminoids transdermal gel), in adult patients with stable SCD. (time frame: Baseline to Day 66). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07566494, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.