Acute Promyelocytic Leukemia (APL)Phase 1NCT06882031
Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution Under Fasting and Fed Conditions, to Compare Intravenous Arsenic Trioxide, in Acute Promyelocytic Leukemia
A Phase 1 study testing Treatment A: Arsenic Trioxide (ATO) Intravenous, Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state and Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state in people with Acute Promyelocytic Leukemia (APL), run by SDK Therapeutics, Inc. at 1 site in Hong Kong.
Trial summary
Randomized, Open-Label Study to evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution (SDK001) under Fasting and Fed Conditions, to Compare to IV Arsenic Trioxide Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Promyelocytic Leukemia (APL)
- What is being tested?
- Treatment A: Arsenic Trioxide (ATO) Intravenous, Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state and Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 Mar 2025to 30 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Diagnosis of APL characterized by the presence of the t(15;17) translocation or promyelocytic leukemia/retinoic acid receptor alpha gene expression
Who cannot join
- Relapsed or refractory APL
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The University of Hong Kong-Clinical Trial Centre Phase 1 Centre
Hong Kong
About this study
Official title: A Randomized, Open Label, Single-Centre, Single-Dose, 4-Period, 4-Treatment Cross-over Study to Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution (SDK001) Under Fasting and Fed Conditions, to Compare to Intravenous Arsenic Trioxide, and to Evaluate Interaction With Calcium Carbonate in Patients With Acute Promyelocytic Leukemia.
Randomized, Open-Label Study to evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution (SDK001) under Fasting and Fed Conditions, to Compare to IV Arsenic Trioxide
- Conditions
- Acute Promyelocytic Leukemia (APL)
- Being tested
- Treatment A: Arsenic Trioxide (ATO) Intravenous, Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state, Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state, Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonate
- Keywords
- APL
- Medical subject headings
- Leukemia, Promyelocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment A: Arsenic Trioxide (ATO) IntravenousDrug
0.15 mg/kg 2-hour IV infusion of ATO administered under fasted state in single dose
Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster stateDrug
0.15 mg/kg SDK001 administered orally under fasted state in single dose
Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed stateDrug
0.15 mg/kg SDK001 administered orally under fed state (high fat breakfast) in single dose
Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonateDrug
0.15 mg/kg SDK001 administered orally with calcium carbonate in tablet form (1g) under fasted state in single dose
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | In this treatment Arm 1, patients will receive one dose of the following interventions one week apart
* A: IV Arsenic Trioxide under fasted state
* B: SDK001 under fasted state
* C: SDK001 under fed state
* D: SDK001 with calcium carbonate under fasted state Receives: Drug: Treatment A: Arsenic Trioxide (ATO) Intravenous; Drug: Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state; Drug: Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state; Drug: Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonate |
| Sequence 2 | Experimental | In this treatment Arm 2, patients will receive one dose of the following interventions one week apart
* B: SDK001 under fasted state
* D: SDK001 with calcium carbonate
* A: IV Arsenic Trioxide under fasted state
* C: SDK001 under fed state Receives: Drug: Treatment A: Arsenic Trioxide (ATO) Intravenous; Drug: Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state; Drug: Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state; Drug: Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonate |
| Sequence 3 | Experimental | In this treatment Arm 3, patients will receive one dose of the following interventions one week apart
* C: SDK001 under fed state
* A: IV Arsenic Trioxide under fasted state
* D: SDK001 with calcium carbonate
* B: SDK001 under fasted state Receives: Drug: Treatment A: Arsenic Trioxide (ATO) Intravenous; Drug: Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state; Drug: Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state; Drug: Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonate |
| Sequence 4 | Experimental | In this treatment Arm 4, patients will receive one dose of the following interventions one week apart
* D: SDK001 with calcium carbonate
* C: SDK001 under fed state
* B: SDK001 under fasted state
* A: IV Arsenic Trioxide under fasted state Receives: Drug: Treatment A: Arsenic Trioxide (ATO) Intravenous; Drug: Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state; Drug: Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state; Drug: Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Randomized, Open Label, Single-Centre, Single-Dose, 4-Period, 4-Treatment Cross-over Study to Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution (SDK001) to Intravenous Arsenic Trioxide
Primary Endpoints
- AUCinf of AsIII (the pharmacologically active species of ATO) for comparison of SDK001 versus IV ATO
Measured: Over 4 weeks in maintenance cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start11 Mar 2025
- Primary completion25 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Promyelocytic Leukemia (APL)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- SDK Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The University of Hong Kong
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882031
- Sponsor's protocol ID
- SDKARS-101
- Other IDs
- 173343
- Status last verified
- Jul 2025
- First submitted
- 23 Jan 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Single-Centre, Single-Dose, 4-Period, 4-Treatment Cross-over Study to Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution (SDK001) Under Fasting and Fed Conditions, to Compare to Intravenous Arsenic Trioxide, and to Evaluate Interaction With Calcium Carbonate in Patients With Acute Promyelocytic Leukemia.
- ClinicalTrials.gov ID
- NCT06882031
- Acronym / sponsor ID
- SDKARS-101
- Conditions
- Acute Promyelocytic Leukemia (APL)
- Keywords
- APL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- SDK Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- The University of Hong Kong
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 18 Mar 2025 (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.
Randomized, Open-Label Study to evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution (SDK001) under Fasting and Fed Conditions, to Compare to IV Arsenic Trioxide
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Treatment A: Arsenic Trioxide (ATO) Intravenous, Drug: Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state, Drug: Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state, Drug: Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonateIn this treatment Arm 1, patients will receive one dose of the following interventions one week apart * A: IV Arsenic Trioxide under fasted state * B: SDK001 under fasted state * C: SDK001 under fed state * D: SDK001 with calcium carbonate under fasted state |
| Sequence 2 | Experimental | Drug: Treatment A: Arsenic Trioxide (ATO) Intravenous, Drug: Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state, Drug: Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state, Drug: Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonateIn this treatment Arm 2, patients will receive one dose of the following interventions one week apart * B: SDK001 under fasted state * D: SDK001 with calcium carbonate * A: IV Arsenic Trioxide under fasted state * C: SDK001 under fed state |
| Sequence 3 | Experimental | Drug: Treatment A: Arsenic Trioxide (ATO) Intravenous, Drug: Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state, Drug: Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state, Drug: Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonateIn this treatment Arm 3, patients will receive one dose of the following interventions one week apart * C: SDK001 under fed state * A: IV Arsenic Trioxide under fasted state * D: SDK001 with calcium carbonate * B: SDK001 under fasted state |
| Sequence 4 | Experimental | Drug: Treatment A: Arsenic Trioxide (ATO) Intravenous, Drug: Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state, Drug: Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state, Drug: Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonateIn this treatment Arm 4, patients will receive one dose of the following interventions one week apart * D: SDK001 with calcium carbonate * C: SDK001 under fed state * B: SDK001 under fasted state * A: IV Arsenic Trioxide under fasted state |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Diagnosis of APL characterized by the presence of the t(15;17) translocation or promyelocytic leukemia/retinoic acid receptor alpha gene expression
Key exclusion criteria (1 listed)
- Relapsed or refractory APL
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 |
|---|---|---|
| Treatment A: Arsenic Trioxide (ATO) Intravenous0.15 mg/kg 2-hour IV infusion of ATO administered under fasted state in single dose | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state0.15 mg/kg SDK001 administered orally under fasted state in single dose | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state0.15 mg/kg SDK001 administered orally under fed state (high fat breakfast) in single dose | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonate0.15 mg/kg SDK001 administered orally with calcium carbonate in tablet form (1g) under fasted state in single dose | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
Primary outcome
A Randomized, Open Label, Single-Centre, Single-Dose, 4-Period, 4-Treatment Cross-over Study to Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution (SDK001) to Intravenous Arsenic Trioxide
Time frame: Over 4 weeks in maintenance cycle
Primary Endpoints • AUCinf of AsIII (the pharmacologically active species of ATO) for comparison of SDK001 versus IV ATO
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Treatment A: Arsenic Trioxide (ATO) Intravenous, Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state and Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state in people with Acute Promyelocytic Leukemia (APL), run by SDK Therapeutics, Inc. at 1 site in Hong Kong.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Nov 2025. 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A Randomized, Open Label, Single-Centre, Single-Dose, 4-Period, 4-Treatment Cross-over Study to Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution (SDK001) to Intravenous Arsenic Trioxide (time frame: Over 4 weeks in maintenance cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2025.