Acute Myeloid LeukemiaPhase 1NCT01054937
Single Dose Study With 4SC-203 in Healthy Volunteers
A Phase 1 study testing 4SC-203 in people with Acute Myeloid Leukemia, run by 4SC AG at 1 site in Germany.
Trial summary
The purpose of the study is to evaluate safety and tolerability of 4SC-203 after a single dose administration in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- 4SC-203
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Nov 2010
- 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 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged 18 to 45 years (included), and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening
- Subjects must be able to communicate well with the investigator, to understand and comply with the requirements of the study, and to understand and sign the written informed consent
Who cannot join
- Evidence of current or previous clinically significant disease, medical condition or finding of the medical examination (including vital signs and ECG), that in the opinion of the investigator would compromise the safety of the subject or the quality of the data
- Current or recent history of significant renal, hepatic, haematological, immunological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the subject's participation in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First-in-Man, Randomised, Double-Blind, Placebo-Controlled, Single Dose Escalation Study of the Novel Compound 4SC-203 in Young Healthy Volunteers
The purpose of the study is to evaluate safety and tolerability of 4SC-203 after a single dose administration in healthy volunteers.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- 4SC-203, Placebo
- Keywords
- 4SC-203, Phase I, single dose, healthy volunteers
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4SC-203Drug
i.v. administration
PlaceboDrug
i.v. administration
| Study group | Role | What they receive |
|---|---|---|
| 4SC-203 | Experimental | Not described Receives: Drug: 4SC-203 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation of safety and tolerability of escalating single doses of 4SC-203.
Measured: 14 days
Secondary outcomes (2)
To investigate the pharmacokinetics of single doses of 4SC-203.
Measured: 14 days
To assess the pharmacodynamic effect by means of appropriate biomarkers.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- 4SC AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Frank Wagner, PD Dr. med., Principal investigator, Charité Research Organisation GmbH, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054937
- Sponsor's protocol ID
- 4SC-203-2-2009
- Status last verified
- Jan 2011
- First submitted
- 21 Jan 2010
- Last updated
- 13 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Man, Randomised, Double-Blind, Placebo-Controlled, Single Dose Escalation Study of the Novel Compound 4SC-203 in Young Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01054937
- Acronym / sponsor ID
- 4SC-203-2-2009
- Conditions
- Acute Myeloid Leukemia
- Keywords
- 4SC-203, Phase I, single dose, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- 4SC AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 22 Jan 2010 (estimated)
- 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.
The purpose of the study is to evaluate safety and tolerability of 4SC-203 after a single dose administration in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4SC-203 | Experimental | Drug: 4SC-203 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male subjects aged 18 to 45 years (included), and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening
- Subjects must be able to communicate well with the investigator, to understand and comply with the requirements of the study, and to understand and sign the written informed consent
Key exclusion criteria (2 listed)
- Evidence of current or previous clinically significant disease, medical condition or finding of the medical examination (including vital signs and ECG), that in the opinion of the investigator would compromise the safety of the subject or the quality of the data
- Current or recent history of significant renal, hepatic, haematological, immunological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the subject's participation in the trial
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 |
|---|---|---|
| 4SC-203i.v. administration | Drug | 4SC-203 |
| Placeboi.v. administration | Drug | Placebo |
Primary outcome
Investigation of safety and tolerability of escalating single doses of 4SC-203.
Time frame: 14 days
2 secondary outcomes
To investigate the pharmacokinetics of single doses of 4SC-203.
Time frame: 14 days
To assess the pharmacodynamic effect by means of appropriate biomarkers.
Time frame: 14 days
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 13 Jan 2011.
Related trials for Acute Myeloid Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Frank Wagner, PD Dr. med. principal investigator
Charité Research Organisation GmbH, Berlin, Germany
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 4SC-203 in people with Acute Myeloid Leukemia, run by 4SC AG at 1 site in Germany.
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 2 inclusion and 2 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 13 Jan 2011. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
Investigation of safety and tolerability of escalating single doses of 4SC-203. (time frame: 14 days). 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 13 Jan 2011.