Alzheimer DementiaPhase 1NCT03955380
MAD Phase I Study to Investigate Contraloid Acetate
A Phase 1 study testing Contraloid in people with Alzheimer Dementia and Alzheimer Disease, run by Prof. Dr. Dieter Willbold at 1 site in Germany.
Trial summary
This is a single-center multiple-ascending-dose clinical trial assessing the safety and tolerability of oral dosing of Contraloid acetate in healthy volunteers. The study drug Contraloid (alias RD2, alias PRI-002) is an orally available all-D-peptide, which was developed to directly destroy toxic and replicating… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Dementia, Alzheimer Disease
- What is being tested?
- Contraloid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 12 Dec 2018to 3 Apr 2019
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female subjects willing and able to give their written consent to participate in the trial after having received information about the study design, the objectives of the project, the possible derivative risks, and their right to withdraw from the study at any time and for any reason.
- Healthy male and female subjects aged within: 18 to 45 years (limits included).
- With clinical history and physical examination results within normality.
- Electrocardiogram without clinically significant pathologic abnormalities and with QTc values lesser than 450 ms.
- Normotensive as defined by Systolic Blood Pressure ≤ 150 mm Hg. Diastolic Blood Pressure ≤ 90 mm Hg.
- BMI between 19.0 and 30.0 kg/m2.
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- Body weight between 55 and 85 kg, inclusive.
- Women who were neither pregnant (negative urine pregnancy test) nor nursing and who were either:
- Surgically sterile (bilateral tubal ligation, hysterectomy)
Who cannot join
- Any chronic medical condition (such as type 1 diabetes) requiring chronic treatment that might increase the risk to the subject or confound the interpretation of safety observations.
- Evidence of active infection requiring antibiotic therapy within 14 days prior to screening.
- Medical history of vasculitis or any autoimmune disease excluding seasonal allergic rhinitis and childhood history of atopic dermatitis.
- History of any treatment for cancer within the past 2 years, other than basal cell or squamous cell carcinoma of the skin.
- Seropositive for human immunodeficiency virus (HIV).
- History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for Hepatitis B surface antigen [HbsAg] or anti-Hepatitis C [HCV] antibody).
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- Clinically significant abnormalities in screening laboratory tests, including:
- Absolute neutrophil count < 1.4 x109
- Alanine transaminase (ALT) or aspartate transaminase (AST) > 1.5 x the upper limit of normal (ULN)
- Absolute lymphocyte count < 1.2 x 109
- Lactate dehydrogenase (LDH) > 1.5 x ULN
- Total bilirubin level: Out of normal range 0-1.5 mg/dL
- eGFR < 60 mL/min
- Hemoglobin (Hgb): out of normal range (male: 13,5-18,0 g/dL, female: 12,0 - 16,0 g/dL)
- CK level higher than 250U/L
- All prescription, over-the-counter and herbal medications are prohibited within 10 days prior to study dosing (with exception of calcium/vitamin D supplements, nasal steroids, ocular medications, and paracetamol ≤1000 mg/day at the discretion of the Investigator).
- Use of an investigational drug within 2 months prior to dosing in this study.
- Any disorder that could interfere with the absorption, distribution, metabolism or excretion of drugs (e.g. small bowel disease, Crohn's disease, celiac disease, or liver disease.)
- Psychiatric history of current or past psychosis, bi-polar disorder, clinical depression, or anxiety disorder requiring chronic medication within the past 5 years.
- History of substance abuse, including alcohol
- Smokers
- History of substance or drug dependence, or positive urine drug screen at screening visit.
- History of head injury.
- Chronic kidney disease (defined as the presence of any degree of proteinuria on urine analysis and/or an eGFR of <60 ml/min using the MDRD formula).
- Any reason or opinion of the investigator that would prevent the subject from participation in the study.
- Inability to follow the instructions or an unwillingness to collaborate during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center, Randomized, Prospective, Double-blind, Placebo Controlled Phase Ib Study With an Adaptive Multiple Ascending Dose (MAD) Design to Investigate the Safety, Tolerability, Pharmacokinetics of Contraloid Acetate (Healthy Subjects)
This is a single-center multiple-ascending-dose clinical trial assessing the safety and tolerability of oral dosing of Contraloid acetate in healthy volunteers. The study drug Contraloid (alias RD2, alias PRI-002) is an orally available all-D-peptide, which was developed to directly destroy toxic and replicating A-beta oligomer prions, by disassembling them into A-beta monomers. The study drug is specifically designed for the curative or at least disease-modifying treatment of cognition, memory and behavior deficits in Alzheimer´s disease patients. The study drug is BBB penetrable [1] and has demonstrated target engagement in vitro and in vivo [2, 3]. Treatments in three different transgenic mouse models in three different laboratories yielded improved cognition and deceleration of neurodegeneration, even under truly non-preventive treatment conditions and even when applied orally [2-5]. The hereby obtained PRI-002 plasma levels have also been achieved in humans after single oral dosing.
Read the detailed description
The investigation on the compound Contraloid acetate in a multiple-ascending-dose phase I study has been performed in 24 healthy male participants, randomly assigned to the treatment. Main focus was on the evaluation of the outcome of the safety and tolerability; secondarily the pharmacokinetic characteristics of the compound were assessed. Two different ascending doses (160 and 320 mg Contraloid) administered orally (for 14 days in the first cohort and for 28 days in the second cohort) as a single daily dose, were tested in two cohorts on respectively eight participants per cohort, additionally four participants of each cohort received placebo.
In order to maintain the highest level of security for the participants of this study a staggered design was used. First, only four sentinels of each cohort were administered with the study drug or placebo (ratio 2:2). Only after assessing all available data by the data safety and monitoring board (DSMB), the rest of the cohort (6 study drug: 2 placebo) were allowed to be treated. This took place on two consecutive days, administering the study drug to four participants per each starting day. After DSMB permission the next dose level was started with the same scheme of administration.
During the screening period the informed consent was obtained and the evaluation of the inclusion and exclusion criteria, collection of demographic data and previous medical history, physical examination and health assessment, 12-lead ECG were performed. Additionally vital signs, haemogram, coagulation, biochemistry and urine analysis determination, as well as serology and testing of drug abuse were carried out.
On the first study day the participants received in fasting conditions the study drug after re-evaluation the inclusion/exclusion criteria. For monitoring the laboratory parameters and the pharmacokinetics of Contraloid blood draws were performed in a predetermined frequency. Physical conditions, vital signs, ECG, concomitant medication, adverse events were monitored closely. Sentinels stayed in the Phase-I Unit for 7 days, and the remaining participants of the cohort for 24 hours. The participants returned daily for administration. On Day 14/28 (cohort 1/cohort 2) the participants were admitted to the phase 1 unit for another 24 h for PK-sampling. A follow-up was performed on Days 16/30, 17/31 and the End of Study Visit on Day 21/35. The study was double-blinded and conducted under the EU regulations and Good Clinical Practice (GCP) and national Austrian law. Monitoring and PV was performed by the CRO NeuroScios, DM by Fundacion Teofilo Hernando, Spain, Bioanalytics by Nuvisan, Germany.It is a Part the Cloud Translational Research Funding award from the Alzheimer´s Association.
Contraloid (alias RD2, alias PRI-002) is an all-D-peptide, which was developed to directly destroy toxic and replicating A-beta oligomer prions, by disassembling them into A-beta monomers. The study drug is specifically designed for the curative or at least disease-modifying treatment of cognition, memory and behavior deficits in Alzheimer´s disease patients. The study drug is BBB penetrable [1] and has demonstrated target engagement in vitro and in vivo [2, 3]. Treatments in three different transgenic mouse models in three different laboratories yielded improved cognition and deceleration of neurodegeneration, even under truly non-preventive treatment conditions and even when applied orally [2-5]. The hereby obtained PRI-002 plasma levels have also been achieved in humans after single oral dosing.
- Conditions
- Alzheimer Dementia, Alzheimer Disease
- Being tested
- Contraloid
- Keywords
- anti-prionic, anti-Abeta-pionic, treatment of cognition and memory deficits, AD patients, AD stage-independent, NOT anti-amyloid, neuron specific Ca-ion reduction
- Medical subject headings
- Alzheimer Disease, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ContraloidDrug
Also called PRI-002
Oral administration of capsules, drug substance or placebo without any exipients.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Contraloid 160 mg | Active comparator | 160 mg Contraloid/participant administered orally (for 14 days in the first cohort and for 28 days in the second cohort) as a single daily dose. Receives: Drug: Contraloid |
| Active Comparator: Contralod 320mg | Active comparator | 320 mg Contraloid/participant administered orally (for 14 days in the first cohort and for 28 days in the second cohort) as a single daily dose. Receives: Drug: Contraloid |
| Placebo Comparator (for Contraloid) 160 mg | Placebo comparator | 160 mg placebo/participant administered orally (for 14 days in the first cohort and for 28 days in the second cohort) as a single daily dose. Receives: Drug: Contraloid |
| Placebo Comparator (for Contraloid) 320 mg | Placebo comparator | 320 mg placebo/participant administered orally (for 14 days in the first cohort and for 28 days in the second cohort) as a single daily dose. Receives: Drug: Contraloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety and tolerability of Contraloid by monitoring vital signs, ECG and lab values
To evaluate the safety and tolerability of Contraloid acetate in healthy subjects by assessing the number, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs.
Measured: 21 days for cohort 1 and 35 days for cohort 2
Assessment of pharmacokinetics of Contraloid: Area under curve (AUC) in plasma
Area under curve (AUC) in plasma
Measured: 168 hours
Assessment of pharmacokinetics of Contraloid: Cmax in plasma
Cmax in plasma
Measured: 21/35 days
Assessment of pharmacokinetics of Contraloid: Tmax in plasma
Tmax in plasma
Measured: 21/35 days
Assessment of pharmacokinetics of Contraloid: Terminal elimination half-life (t1/2) in plasma
Terminal elimination half-life (t1/2) in plasma
Measured: 21/35 days
Assessment of pharmacokinetics of Contraloid: distributive half-life (t1/2alpha) in plasma
distributive half-life (t1/2alpha) in plasma
Measured: 21/35 days
Assessment of pharmacokinetics of Contraloid: terminal elimination half-life (t1/2beta) in plasma
Terminal elimination half-life (t1/2beta) in plasma
Measured: 21/35 days
Assessment of pharmacokinetics of Contraloid: Elimination Constant (Kel alpha) in plasma
Elimination Constant (Kel alpha) in plasma
Measured: 21/35 days
Assessment of pharmacokinetics of Contraloid: Elimination Constant (Kel beta) in plasma
Elimination Constant (Kel beta) in plasma
Measured: 21/35 days
AUC0-24 of Contraloid does not exceed of 2.3 µg·h/mL
Additionally, the AUC0-24 values of Contraloid in plasma will be determined in order to ensure that the recommended AUC0-24 of Contraloid does not exceed of 2.3 µg·h/mL in any of the subjects.
Measured: 21/35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start12 Dec 2018
- Primary completion3 Apr 2019
- Study completion3 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DementiaStudies 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
- Model description
- Randomized, double-blind, placebo-controlled, multiple ascending dose, multi-cohort
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Dieter Willbold
- Sponsor type
- University, hospital or other
- Collaborators
- Helmholtz-Gemeinschaft Deutscher Forschungszentren, Germany, Medical University of Vienna, NeuroScios, Austria, Nuvisan, Germany, Fundación Teófilo Hernando, Spain, Alzheimer's Association
- Responsible party
- Sponsor-investigator, Prof. Dr. Dieter Willbold, Forschungszentrum Juelich
- Investigators
- Michael Wolzt, MD, Principal investigator, University of Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955380
- Sponsor's protocol ID
- EUDRA-CT: 2018-002500-14
- Status last verified
- May 2019
- First submitted
- 14 May 2019
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only as far as covered by the EU GDPR and regulated by GCP
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Randomized, Prospective, Double-blind, Placebo Controlled Phase Ib Study With an Adaptive Multiple Ascending Dose (MAD) Design to Investigate the Safety, Tolerability, Pharmacokinetics of Contraloid Acetate (Healthy Subjects)
- ClinicalTrials.gov ID
- NCT03955380
- Acronym / sponsor ID
- EUDRA-CT: 2018-002500-14
- Conditions
- Alzheimer Dementia, Alzheimer Disease
- Keywords
- anti-prionic, anti-Abeta-pionic, treatment of cognition and memory deficits, AD patients, AD stage-independent, NOT anti-amyloid, neuron specific Ca-ion reduction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Prof. Dr. Dieter WillboldUniversity, hospital or other
- Collaborators
- Helmholtz-Gemeinschaft Deutscher Forschungszentren, Germany, Medical University of Vienna, NeuroScios, Austria, Nuvisan, Germany, Fundación Teófilo Hernando, Spain, Alzheimer's Association
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 3 Apr 2019 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 20 May 2019 (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.
This is a single-center multiple-ascending-dose clinical trial assessing the safety and tolerability of oral dosing of Contraloid acetate in healthy volunteers. The study drug Contraloid (alias RD2, alias PRI-002) is an orally available all-D-peptide, which was developed to directly destroy toxic and replicating A-beta oligomer prions, by disassembling them into A-beta monomers. The study drug is specifically designed for the curative or at least disease-modifying treatment of cognition, memory and behavior deficits in Alzheimer´s disease patients. The study drug is BBB penetrable [1] and has demonstrated target engagement in vitro and in vivo [2, 3]. Treatments in three different transgenic mouse models in three different laboratories yielded improved cognition and deceleration of neurodegeneration, even under truly non-preventive treatment conditions and even when applied orally [2-5]. The hereby obtained PRI-002 plasma levels have also been achieved in humans after single oral dosing.
Detailed description
The investigation on the compound Contraloid acetate in a multiple-ascending-dose phase I study has been performed in 24 healthy male participants, randomly assigned to the treatment. Main focus was on the evaluation of the outcome of the safety and tolerability; secondarily the pharmacokinetic characteristics of the compound were assessed. Two different ascending doses (160 and 320 mg Contraloid) administered orally (for 14 days in the first cohort and for 28 days in the second cohort) as a single daily dose, were tested in two cohorts on respectively eight participants per cohort, additionally four participants of each cohort received placebo.
In order to maintain the highest level of security for the participants of this study a staggered design was used. First, only four sentinels of each cohort were administered with the study drug or placebo (ratio 2:2). Only after assessing all available data by the data safety and monitoring board (DSMB), the rest of the cohort (6 study drug: 2 placebo) were allowed to be treated. This took place on two consecutive days, administering the study drug to four participants per each starting day. After DSMB permission the next dose level was started with the same scheme of administration.
During the screening period the informed consent was obtained and the evaluation of the inclusion and exclusion criteria, collection of demographic data and previous medical history, physical examination and health assessment, 12-lead ECG were performed. Additionally vital signs, haemogram, coagulation, biochemistry and urine analysis determination, as well as serology and testing of drug abuse were carried out.
On the first study day the participants received in fasting conditions the study drug after re-evaluation the inclusion/exclusion criteria. For monitoring the laboratory parameters and the pharmacokinetics of Contraloid blood draws were performed in a predetermined frequency. Physical conditions, vital signs, ECG, concomitant medication, adverse events were monitored closely. Sentinels stayed in the Phase-I Unit for 7 days, and the remaining participants of the cohort for 24 hours. The participants returned daily for administration. On Day 14/28 (cohort 1/cohort 2) the participants were admitted to the phase 1 unit for another 24 h for PK-sampling. A follow-up was performed on Days 16/30, 17/31 and the End of Study Visit on Day 21/35. The study was double-blinded and conducted under the EU regulations and Good Clinical Practice (GCP) and national Austrian law. Monitoring and PV was performed by the CRO NeuroScios, DM by Fundacion Teofilo Hernando, Spain, Bioanalytics by Nuvisan, Germany.It is a Part the Cloud Translational Research Funding award from the Alzheimer´s Association.
Contraloid (alias RD2, alias PRI-002) is an all-D-peptide, which was developed to directly destroy toxic and replicating A-beta oligomer prions, by disassembling them into A-beta monomers. The study drug is specifically designed for the curative or at least disease-modifying treatment of cognition, memory and behavior deficits in Alzheimer´s disease patients. The study drug is BBB penetrable [1] and has demonstrated target engagement in vitro and in vivo [2, 3]. Treatments in three different transgenic mouse models in three different laboratories yielded improved cognition and deceleration of neurodegeneration, even under truly non-preventive treatment conditions and even when applied orally [2-5]. The hereby obtained PRI-002 plasma levels have also been achieved in humans after single oral dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Randomized, double-blind, placebo-controlled, multiple ascending dose, multi-cohort
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Contraloid 160 mg | Active comparator | Drug: Contraloid160 mg Contraloid/participant administered orally (for 14 days in the first cohort and for 28 days in the second cohort) as a single daily dose. |
| Active Comparator: Contralod 320mg | Active comparator | Drug: Contraloid320 mg Contraloid/participant administered orally (for 14 days in the first cohort and for 28 days in the second cohort) as a single daily dose. |
| Placebo Comparator (for Contraloid) 160 mg | Placebo comparator | Drug: Contraloid160 mg placebo/participant administered orally (for 14 days in the first cohort and for 28 days in the second cohort) as a single daily dose. |
| Placebo Comparator (for Contraloid) 320 mg | Placebo comparator | Drug: Contraloid320 mg placebo/participant administered orally (for 14 days in the first cohort and for 28 days in the second cohort) as a single daily dose. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male and female subjects willing and able to give their written consent to participate in the trial after having received information about the study design, the objectives of the project, the possible derivative risks, and their right to withdraw from the study at any time and for any reason.
- Healthy male and female subjects aged within: 18 to 45 years (limits included).
- With clinical history and physical examination results within normality.
- Electrocardiogram without clinically significant pathologic abnormalities and with QTc values lesser than 450 ms.
- Normotensive as defined by Systolic Blood Pressure ≤ 150 mm Hg. Diastolic Blood Pressure ≤ 90 mm Hg.
Key exclusion criteria (26 listed)
- Any chronic medical condition (such as type 1 diabetes) requiring chronic treatment that might increase the risk to the subject or confound the interpretation of safety observations.
- Evidence of active infection requiring antibiotic therapy within 14 days prior to screening.
- Medical history of vasculitis or any autoimmune disease excluding seasonal allergic rhinitis and childhood history of atopic dermatitis.
- History of any treatment for cancer within the past 2 years, other than basal cell or squamous cell carcinoma of the skin.
- Seropositive for human immunodeficiency virus (HIV).
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 |
|---|---|---|
| ContraloidAlso: PRI-002Oral administration of capsules, drug substance or placebo without any exipients. | Drug | Active Comparator: Contralod 320mg, Active Comparator: Contraloid 160 mg, Placebo Comparator (for Contraloid) 160 mg, Placebo Comparator (for Contraloid) 320 mg |
Primary outcome
Assessment of safety and tolerability of Contraloid by monitoring vital signs, ECG and lab values
Time frame: 21 days for cohort 1 and 35 days for cohort 2
To evaluate the safety and tolerability of Contraloid acetate in healthy subjects by assessing the number, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs.
Assessment of pharmacokinetics of Contraloid: Area under curve (AUC) in plasma
Time frame: 168 hours
Area under curve (AUC) in plasma
Assessment of pharmacokinetics of Contraloid: Cmax in plasma
Time frame: 21/35 days
Cmax in plasma
Assessment of pharmacokinetics of Contraloid: Tmax in plasma
Time frame: 21/35 days
Tmax in plasma
Assessment of pharmacokinetics of Contraloid: Terminal elimination half-life (t1/2) in plasma
Time frame: 21/35 days
Terminal elimination half-life (t1/2) in plasma
Assessment of pharmacokinetics of Contraloid: distributive half-life (t1/2alpha) in plasma
Time frame: 21/35 days
distributive half-life (t1/2alpha) in plasma
Assessment of pharmacokinetics of Contraloid: terminal elimination half-life (t1/2beta) in plasma
Time frame: 21/35 days
Terminal elimination half-life (t1/2beta) in plasma
Assessment of pharmacokinetics of Contraloid: Elimination Constant (Kel alpha) in plasma
Time frame: 21/35 days
Elimination Constant (Kel alpha) in plasma
Assessment of pharmacokinetics of Contraloid: Elimination Constant (Kel beta) in plasma
Time frame: 21/35 days
Elimination Constant (Kel beta) in plasma
AUC0-24 of Contraloid does not exceed of 2.3 µg·h/mL
Time frame: 21/35 days
Additionally, the AUC0-24 values of Contraloid in plasma will be determined in order to ensure that the recommended AUC0-24 of Contraloid does not exceed of 2.3 µg·h/mL in any of the subjects.
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 20 May 2019.
- Individual participant dataSharing planned: No. Only as far as covered by the EU GDPR and regulated by GCP
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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.
Michael Wolzt, MD principal investigator
University of Vienna, Austria
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 Contraloid in people with Alzheimer Dementia and Alzheimer Disease, run by Prof. Dr. Dieter Willbold 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 9 inclusion and 26 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 20 May 2019. 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?
Assessment of safety and tolerability of Contraloid by monitoring vital signs, ECG and lab values (time frame: 21 days for cohort 1 and 35 days for cohort 2). The study lists 10 primary outcomes in all. 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 20 May 2019.