Cerebrovascular StrokePhase 1NCT04103034

A SAD/MAD Study of Safety, Tolerability and Pharmacologic Activity of BT200 in Normal Volunteers

A Phase 1 study testing BT200 and Desmopressin in people with Cerebrovascular Stroke and Large-Artery Atherosclerosis (Embolus/Thrombosis), run by Band Therapeutics at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Cerebrovascular Stroke, Large-Artery Atherosclerosis (Embolus/Thrombosis), Intracranial Arteriosclerosis
What is being tested?: BT200 and Desmopressin
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 112 participants
Where: 1 siteAustria
Study dates: 7 Oct 2019to 14 Sep 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy male or female volunteers, age ≥ 18 years old at screening
If female, must be post-menopausal or status post hysterectomy
Able to comprehend and to give informed consent
Able to cooperate with the Investigator, to comply with the requirements of the study, and to complete the full sequence of protocol-related procedures

Who cannot join

Clinically significant medical history (including von Willebrand Disease, thrombocytopathy, or any type of bleeding diathesis) or ongoing chronic illness that would jeopardize the safety of the subject or compromise the quality of the data derived from his/her participation in this study
Clinically relevant abnormal findings on physical examination or clinically relevant laboratory abnormalities
History of infusion hypersensitivity reactions, significant drug allergy, or anaphylactic reactions
Substance abuse, mental illness, or any reason that makes it unlikely in the judgment of the Investigator for the subject to be able to comply fully with study procedures
Use of medication during 2 weeks before the start of the study, which in the judgment of the Investigator may adversely affect the subject's welfare or the integrity of the study's results
Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days or 5 elimination half-lives (whichever is longer) prior to treatment start

Trial locations and contacts

1 site in 1 country.

Austria1 site

Medical University of Vienna
Vienna, 1090

Other trials in Austria

About this study

Official title: A Single/Multiple Ascending Dose Phase 1 Study of the Safety, Tolerability and Pharmacologic Activity of BT200 in Normal Human Volunteers

Study BT200-01 is a first in human (FIH) study in male and female normal human volunteers (NHVs) that uses an Integrated Protocol Design. This Phase 1 study will comprise 4 sub-parts: Part A, a single ascending dose (SAD) study; Part B, a multiple ascending dose (MAD) study; Part C, a desmopressin challenge study to explore (i) whether desmopressin could be used as an antidote, and/or (ii) whether desmopressin stimulated vonWillebrand Factor (VWF) release is overcome with increasing BT200 doses; and Part D, a relative bioavailability (BA) study.

The primary objective of this study is to assess the safety and tolerability profile of BT200 in NHVs.

Conditions: Cerebrovascular Stroke, Large-Artery Atherosclerosis (Embolus/Thrombosis), Intracranial Arteriosclerosis
Being tested: BT200, Desmopressin, Placebo
Keywords: Secondary Stroke Prevention
Medical subject headings: Stroke, Embolism, Thrombosis, Intracranial Arteriosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BT200Drug
BT200 is a PEGylated synthetic RNA oligonucleotide
DesmopressinDrug
Also called MINIRIN® Injection
Sterile solution for injection
PlaceboDrug
Sterile saline for injection

Study groups in NCT04103034
Study group	Role	What they receive
BT200 0.18mg	Experimental	Subjects will receive a single subcutaneous dose of BT200 0.18mg Receives: Drug: BT200
BT200 0.6mg	Experimental	Subjects will receive a single subcutaneous dose of BT200 0.6mg Receives: Drug: BT200
BT200 1.8mg	Experimental	Subjects will receive a single subcutaneous dose of BT200 1.8mg Receives: Drug: BT200
BT200 6.0mg	Experimental	Subjects will receive a single subcutaneous dose of BT200 6.0mg Receives: Drug: BT200
BT200 12.0mg	Experimental	Subjects will receive a single subcutaneous dose of BT200 12.0mg Receives: Drug: BT200
BT200 24.0mg	Experimental	Subjects will receive a single subcutaneous dose of BT200 24.0mg Receives: Drug: BT200
BT200 24.0mg rep	Experimental	Subjects will receive a single subcutaneous (SC) dose of BT200 24.0mg by gradual SC infusion Receives: Drug: BT200
Placebo SAD	Placebo comparator	Subjects will receive a single subcutaneous dose of placebo Receives: Drug: Placebo
BT200 loading dose 12.0mg, maintenance doses of 12.0 mg	Experimental	Subjects will receive an initial subcutaneous loading doses of BT200 12.0mg followed by 4 weekly (every 7 days) maintenance doses of BT200 12.0mg Receives: Drug: BT200
BT200 loading doses 24.0mg, maintenance doses of 24.0 mg	Experimental	Subjects will receive an initial subcutaneous loading dose of BT200 24mg followed by 4 weekly (every 7 days) maintenance doses of BT200 24mg Receives: Drug: BT200
Placebo MAD	Placebo comparator	Subjects will receive an initial subcutaneous loading dose of Placebo followed by 4 weekly (every 7 days) maintenance doses of placebo Receives: Drug: Placebo
BT200 48.0mg + desmopressin challenge	Experimental	Subjects will receive a single subcutaneous dose of BT200 48.0mg followed by IV infusion (over 30 min) of 0.3µg/kg desmopressin administered 24 hours after single dose of BT200 Receives: Drug: BT200; Drug: Desmopressin
Placebo + desmopressin challenge dose	Placebo comparator	Subjects will receive a single subcutaneous dose of placebo followed by IV infusion (over 30 min of 0.3µg/kg desmopressin administered 24 hours after single dose of placebo Receives: Drug: BT200; Drug: Desmopressin
Placebo infusion	Placebo comparator	Subjects will receive a single IV dose of placebo administered over 24 hours Receives: Drug: Placebo
BT200 36.0mg	Experimental	Subjects will receive a single subcutaneous (SC) dose of BT200 36.0mg by gradual SC infusion Receives: Drug: BT200
BT200 48.0 mg	Experimental	Subjects will receive a single subcutaneous dose (SC) of BT200 48.0mg by gradual SC infusion Receives: Drug: BT200
BT200 18.0 mg	Experimental	Subjects will receive a single subcutaneous (SC) dose of BT200 18.0mg by gradual SC infusion Receives: Drug: BT200
BT200 24mg IV infusion	Experimental	Subjects will receive a single IV dose of BT200 24mg administered over 24 hours Receives: Drug: BT200

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Any AE or bleeding event related to study treatment
Measured: Baseline through 8 weeks after dosing up to 56 days

Secondary outcomes (3)

Measured Area Under the Curve (AUC)
Measured Area Under the Curve at timepoints pre-dose, 0.5h, 1h, 4h, 8h,14h, 24h, 48h, 72h, 96h, 168h, 14d, 21d, 28d, 42d, 56d post dose
Measured: Baseline through 8 weeks after dosing up to 56 days
Maximum Plasma Concentration (Cmax)
Maximum plasma Concentration measured at pre-dose, 0.5h, 1h, 4h, 8h,14h, 24h, 48h, 72h, 96h, 168h, 14d, 21d, 28d, 42d, 56d
Measured: Baseline through 8 weeks after dosing up to 56 days
Time to Maximum Plasma Concentration (Tmax)
Time to maximum plasma concentration measured at pre-dose, 0.5h, 1h, 4h, 8h,14h, 24h, 48h, 72h, 96h, 168h, 14d, 21d, 28d, 42d, 56d
Measured: Baseline through 8 weeks after dosing up to 56 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Oct 201914 Sep 2020

First posted25 Sep 2019
Study start7 Oct 2019
Primary completion14 Sep 2020
Study completion14 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Cerebrovascular StrokeStudies 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04103034
Sponsor's protocol ID: BT200-01
Status last verified: Sep 2023
First submitted: 19 Sep 2019
Last updated: 18 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Buchtele N, Schwameis M, Gilbert JC, Schorgenhofer C, Jilma B. Targeting von Willebrand Factor in Ischaemic Stroke: Focus on Clinical Evidence. Thromb Haemost. 2018 Jun;118(6):959-978. doi: 10.1055/s-0038-1648251. Epub 2018 May 30.
PubMed 29847840
Kovacevic KD, Grafeneder J, Schorgenhofer C, Gelbenegger G, Gager G, Firbas C, Quehenberger P, Jilma-Stohlawetz P, Bileck A, Zhu S, Gilbert JC, Beliveau M, Jilma B, Derhaschnig U. The von Willebrand factor A-1 domain binding aptamer BT200 elevates plasma levels of von Willebrand factor and factor VIII: a first-in-human trial. Haematologica. 2022 Sep 1;107(9):2121-2132. doi: 10.3324/haematol.2021.279948.
PubMed 34818873
Denis CV, Lenting PJ. How to keep the factor VIII/von Willebrand factor complex in the circulation. Haematologica. 2022 Sep 1;107(9):2011-2013. doi: 10.3324/haematol.2021.280222. No abstract available.
PubMed 34818875

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cerebrovascular Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single/Multiple Ascending Dose Phase 1 Study of the Safety, Tolerability and Pharmacologic Activity of BT200 in Normal Human Volunteers
ClinicalTrials.gov ID: NCT04103034
Acronym / sponsor ID: BT200-01
Conditions: Cerebrovascular Stroke, Large-Artery Atherosclerosis (Embolus/Thrombosis), Intracranial Arteriosclerosis
Keywords: Secondary Stroke Prevention
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: Band TherapeuticsIndustry (pharma, biotech, devices)
Study start: 7 Oct 2019 (actual)
Primary completion: 14 Sep 2020 (actual)
Study completion: 14 Sep 2020 (actual)
First posted: 25 Sep 2019 (actual)
Results: Posted 18 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objective of this study is to assess the safety and tolerability profile of BT200 in NHVs.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 18

Arm	Type	Receives
BT200 0.18mg	Experimental	Drug: BT200Subjects will receive a single subcutaneous dose of BT200 0.18mg
BT200 0.6mg	Experimental	Drug: BT200Subjects will receive a single subcutaneous dose of BT200 0.6mg
BT200 1.8mg	Experimental	Drug: BT200Subjects will receive a single subcutaneous dose of BT200 1.8mg
BT200 6.0mg	Experimental	Drug: BT200Subjects will receive a single subcutaneous dose of BT200 6.0mg
BT200 12.0mg	Experimental	Drug: BT200Subjects will receive a single subcutaneous dose of BT200 12.0mg
BT200 24.0mg	Experimental	Drug: BT200Subjects will receive a single subcutaneous dose of BT200 24.0mg
BT200 24.0mg rep	Experimental	Drug: BT200Subjects will receive a single subcutaneous (SC) dose of BT200 24.0mg by gradual SC infusion
Placebo SAD	Placebo comparator	Drug: PlaceboSubjects will receive a single subcutaneous dose of placebo
BT200 loading dose 12.0mg, maintenance doses of 12.0 mg	Experimental	Drug: BT200Subjects will receive an initial subcutaneous loading doses of BT200 12.0mg followed by 4 weekly (every 7 days) maintenance doses of BT200 12.0mg
BT200 loading doses 24.0mg, maintenance doses of 24.0 mg	Experimental	Drug: BT200Subjects will receive an initial subcutaneous loading dose of BT200 24mg followed by 4 weekly (every 7 days) maintenance doses of BT200 24mg
Placebo MAD	Placebo comparator	Drug: PlaceboSubjects will receive an initial subcutaneous loading dose of Placebo followed by 4 weekly (every 7 days) maintenance doses of placebo
BT200 48.0mg + desmopressin challenge	Experimental	Drug: BT200, Drug: DesmopressinSubjects will receive a single subcutaneous dose of BT200 48.0mg followed by IV infusion (over 30 min) of 0.3µg/kg desmopressin administered 24 hours after single dose of BT200
Placebo + desmopressin challenge dose	Placebo comparator	Drug: BT200, Drug: DesmopressinSubjects will receive a single subcutaneous dose of placebo followed by IV infusion (over 30 min of 0.3µg/kg desmopressin administered 24 hours after single dose of placebo
Placebo infusion	Placebo comparator	Drug: PlaceboSubjects will receive a single IV dose of placebo administered over 24 hours
BT200 36.0mg	Experimental	Drug: BT200Subjects will receive a single subcutaneous (SC) dose of BT200 36.0mg by gradual SC infusion
BT200 48.0 mg	Experimental	Drug: BT200Subjects will receive a single subcutaneous dose (SC) of BT200 48.0mg by gradual SC infusion
BT200 18.0 mg	Experimental	Drug: BT200Subjects will receive a single subcutaneous (SC) dose of BT200 18.0mg by gradual SC infusion
BT200 24mg IV infusion	Experimental	Drug: BT200Subjects will receive a single IV dose of BT200 24mg administered over 24 hours

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Healthy male or female volunteers, age ≥ 18 years old at screening
If female, must be post-menopausal or status post hysterectomy
Able to comprehend and to give informed consent
Able to cooperate with the Investigator, to comply with the requirements of the study, and to complete the full sequence of protocol-related procedures

Key exclusion criteria (6 listed)

Clinically significant medical history (including von Willebrand Disease, thrombocytopathy, or any type of bleeding diathesis) or ongoing chronic illness that would jeopardize the safety of the subject or compromise the quality of the data derived from his/her participation in this study
Clinically relevant abnormal findings on physical examination or clinically relevant laboratory abnormalities
History of infusion hypersensitivity reactions, significant drug allergy, or anaphylactic reactions
Substance abuse, mental illness, or any reason that makes it unlikely in the judgment of the Investigator for the subject to be able to comply fully with study procedures
Use of medication during 2 weeks before the start of the study, which in the judgment of the Investigator may adversely affect the subject's welfare or the integrity of the study's results

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
BT200BT200 is a PEGylated synthetic RNA oligonucleotide	Drug	BT200 0.18mg, BT200 0.6mg, BT200 1.8mg, BT200 12.0mg, BT200 18.0 mg, BT200 24.0mg, BT200 24.0mg rep, BT200 24mg IV infusion, BT200 36.0mg, BT200 48.0 mg, BT200 48.0mg + desmopressin challenge, BT200 6.0mg, BT200 loading dose 12.0mg, maintenance doses of 12.0 mg, BT200 loading doses 24.0mg, maintenance doses of 24.0 mg, Placebo + desmopressin challenge dose
DesmopressinAlso: MINIRIN® InjectionSterile solution for injection	Drug	BT200 48.0mg + desmopressin challenge, Placebo + desmopressin challenge dose
PlaceboSterile saline for injection	Drug	Placebo MAD, Placebo SAD, Placebo infusion

Primary outcome

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time frame: Baseline through 8 weeks after dosing up to 56 days
Any AE or bleeding event related to study treatment

3 secondary outcomes

Measured Area Under the Curve (AUC)
Time frame: Baseline through 8 weeks after dosing up to 56 days
Maximum Plasma Concentration (Cmax)
Time frame: Baseline through 8 weeks after dosing up to 56 days
Time to Maximum Plasma Concentration (Tmax)
Time frame: Baseline through 8 weeks after dosing up to 56 days

Results and safety

Results posted to the registry on 18 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BT200 0.18mg	6	6
BT200 0.6mg	6	6
BT200 1.8mg	6	6
BT200 6.0mg	6	6
BT200 12.0mg	6	6
BT200 24.0mg	6	6
BT200 24.0mg Rep	6	6
Placebo SAD	20	19
BT200 Loading Dose 24.0mg, Maintenance Doses of 12.0 mg	6	6
BT200 Loading Doses 48.0mg, Maintenance Doses of 24.0 mg	6	0
Placebo MAD	4	2
BT200 48.0mg + Desmopressin Challenge	6	6
Placebo + Desmopressin Challenge Dose	2	2
Placebo Infusion	2	2
BT200 36.0mg	6	5
BT200 48.0 mg	6	4
BT200 18.0 mg	6	6
BT200 24mg IV Infusion	6	6

Primary outcome: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

Time frame: Baseline through 8 weeks after dosing up to 56 days. Count of participants. Unit: Participants

Measure	BT200 0.18mg n = 6	BT200 0.6mg n = 6	BT200 1.8mg n = 6	BT200 6.0mg n = 6	BT200 12.0mg n = 6	BT200 24.0mg n = 6	BT200 24.0mg Rep n = 6	Placebo SAD n = 20	BT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mg n = 6	BT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mg n = 6	Placebo MAD n = 4	BT200 48.0mg + Desmopressin Challenge n = 6	Placebo + Desmopressin Challenge Dose n = 2	Placebo Infusion n = 2	BT200 36.0mg n = 6	BT200 48.0 mg n = 6	BT200 18.0 mg n = 6	BT200 24mg IV Infusion n = 6
Value	0	1	0	1	1	0	1	2	4	3	3	3	0	0	0	3	2	0

Population analysed: Safety population

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from time of screening up to 56 days post dose. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BT200 0.18mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
BT200 0.6mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
BT200 1.8mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
BT200 6.0mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
BT200 12.0mg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
BT200 24.0mg	0 of 6 (0%)	6 of 6 (100%)	0 of 6
BT200 24.0mg Rep	1 of 6 (16.7%)	5 of 6 (83.3%)	0 of 6
Placebo SAD	1 of 20 (5%)	16 of 20 (80%)	0 of 20
BT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mg	0 of 6 (0%)	6 of 6 (100%)	0 of 6
BT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mg	1 of 6 (16.7%)	6 of 6 (100%)	0 of 6
Placebo MAD	0 of 4 (0%)	4 of 4 (100%)	0 of 4
BT200 48.0mg + Desmopressin Challenge	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Placebo + Desmopressin Challenge Dose	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Placebo Infusion	0 of 2 (0%)	1 of 2 (50%)	0 of 2
BT200 36.0mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
BT200 48.0 mg	1 of 6 (16.7%)	4 of 6 (66.7%)	0 of 6
BT200 18.0 mg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
BT200 24mg IV Infusion	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29847840Buchtele N, Schwameis M, Gilbert JC, Schorgenhofer C, Jilma B. Targeting von Willebrand Factor in Ischaemic Stroke: Focus on Clinical Evidence. Thromb Haemost. 2018 Jun;118(6):959-978. doi: 10.1055/s-0038-1648251. Epub 2018 May 30.
Results publication: PubMed 34818873Kovacevic KD, Grafeneder J, Schorgenhofer C, Gelbenegger G, Gager G, Firbas C, Quehenberger P, Jilma-Stohlawetz P, Bileck A, Zhu S, Gilbert JC, Beliveau M, Jilma B, Derhaschnig U. The von Willebrand factor A-1 domain binding aptamer BT200 elevates plasma levels of von Willebrand factor and factor VIII: a first-in-human trial. Haematologica. 2022 Sep 1;107(9):2121-2132. doi: 10.3324/haematol.2021.279948.
Results publication: PubMed 34818875Denis CV, Lenting PJ. How to keep the factor VIII/von Willebrand factor complex in the circulation. Haematologica. 2022 Sep 1;107(9):2011-2013. doi: 10.3324/haematol.2021.280222. No abstract available.

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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.

James C Gilbert, MD study director

Band Therapeutics

Ulla Derhaschnig, MD principal investigator

Medical University of Vienna

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 BT200 and Desmopressin in people with Cerebrovascular Stroke and Large-Artery Atherosclerosis (Embolus/Thrombosis), run by Band Therapeutics at 1 site in Austria.

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 4 inclusion and 6 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 Mar 2024. 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 Austria. 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?

Yes. Results are posted in the registry (first posted 18 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 (time frame: Baseline through 8 weeks after dosing up to 56 days). 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 NCT04103034, which also lists 3 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 18 Mar 2024.