Healthy VolunteersPhase 1LML134NCT02334449
First-in-human Study to Assess the Safety and Pharmacokinetics of LML134 in Healthy Volunteers
A Phase 1 study testing LML134 in people with Healthy Volunteers, run by Novartis Pharmaceuticals at 1 site in Germany.
Trial summary
Phase I study to assess the safety, tolerability and pharmacokinetics of ascending single and multiple doses of the investigational medicinal product in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- LML134
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2015to Feb 2016
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects age 18 to 55 years of age included, and in good health as determined by medical history, physical examination, vital signs, electrocardiogram, and laboratory tests.
- Written informed consent must be obtained before any assessment is performed.
- Able to communicate well with the Investigator, to understand and comply with the requirements of the study.
Who cannot join
- History or presence of epilepsy or of seizures or convulsions of any kind.
- Any clinically relevant abnormalities identified in the resting EEG during screening, or pre-ictal signs or other clinically relevant abnormalities in the hyperventilation or intermittent photic stimulation EEG during screening.
- History of head trauma leading to clinically significant symptoms in the past two years.
- Applies only to subjects enrolled in Part 2 MAD. Score "yes" on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years.
- Significant illness including any clinically significant infectious disease which has not resolved within two (2) weeks prior to initial dosing.
- History or presence of significant hematological abnormalities or immunodeficiency or any condition that might compromise the immune system (infection, vaccination), of any etiology as indicated by clinically significantly abnormal values of any of the following hematologic parameters: thrombocyte, RBC count, total WBC count and differentials presented as % of total white blood cell count and as absolute concentrations.
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- History or presence of any thyroid disease as indicated by any clinically relevant abnormality on thyroid stimulating hormone test (TSH).
- History or presence of any chronic eye disease other than refractive error, strabismic amblyopia, or anisometropic amblyopia.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Oral Dose Study, to Assess the Safety, Tolerability and Pharmacokinetics of LML134 in Healthy Volunteers
Phase I study to assess the safety, tolerability and pharmacokinetics of ascending single and multiple doses of the investigational medicinal product in healthy volunteers
- Conditions
- Healthy Volunteers
- Being tested
- LML134, Placebo
- Keywords
- healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LML134Drug
LML134 will be administered first as single doses and then as multiple doses
PlaceboDrug
All study cohorts (except food effect cohort) are placebo controlled
| Study group | Role | What they receive |
|---|---|---|
| Single dose study part | Experimental | there will be 8 cohorts of healthy volunteers dosed with single doses of LML134 (8 planned dose levels) or with placebo and 2 potential additional cohorts (also dosed with single dose of LML134 or placebo) Receives: Drug: LML134; Drug: Placebo |
| Multiple dose study part | Experimental | there will be 3 cohorts of healthy volunteers dosed with multiple doses of LML134 (3 planned dose levels) or placebo and one potential additional cohort (also dosed with multiple doses of LML134 or placebo) Receives: Drug: LML134; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion
This safety outcome combines the measure of the number of subjects experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatments.
Measured: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Cardiovascular safety assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion
This safety outcome combines the measure of a set of cardiovascular safety parameters extracted from ECGs, 25 hours-Holter ECGs and from vital signs assessments
Measured: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Central nervous system safety assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion
This safety outcome combines the measure of a set of central nervous system safety parameters extracted from EEGs and neurological examinations
Measured: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Ocular safety assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion
This safety outcome combined the measure of a set of ocular parameters including best corrected visual acuity and other parameters assessed by the mean of slit lamp biomicroscopy and dilated ophthalmoscopy examinations and by optical coherence tomography and electroretinography
Measured: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
General safety assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion
This general safety outcome combines the measure of blood laboratory parameters and the outcome of physical examinations
Measured: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Secondary outcomes (12)
Pharmacokinetics (PK) of LML134: time to reach the maximum concentration after a single drug administration (Tmax) in Part 1 and in Part 3
Serum samples will be collected on Day 1: 1hr predose; 0,25h; 0,5h; 1h; 1,5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h post dose, on Day 2: 24h and 36h post dose, on Day 3: 48h and 60h post dose and on Day 4: 72h post dose. This outcome measure shows the mean of all subject values resulting from each time point specified above, in Parts 1 and 3.
In Part 3, the outcome measure is done once without food intake and once after the intake of a high fat breakfast (in 2 different periods). Both outcomes (with and without breakfast intake) will be compared to assess the effect of a high fast breakfast on LML134 Tmax
Measured: Starting 1hour prior to dosing on Day 1 and until 72 hours after dosing (Day 4)
PK of LML134: Observed maximum serum concentration following single drug administration (Cmax) in Part 1 and Part 3
Serum samples will be collected on Day 1: 1hr predose; 0,25h; 0,5h; 1h; 1,5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h post dose, on Day 2: 24h and 36h post dose, on Day 3: 48h and 60h post dose and on Day 4: 72h post dose. This outcome measure shows the mean of all subject values resulting from each time point specified above, in Parts 1 and 3.
In Part 3, the outcome measure is done once without food intake and once after the intake of a high fat breakfast (in 2 different periods). Both outcomes (with and without breakfast intake) will be compared to assess the effect of a high fast breakfast on LML134 Cmax.
Measured: Starting 1hour prior to dosing on Day 1 and until 72 hours after dosing (Day 4)
PK of LML134: Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) in Part 1 and Part 3
Serum samples will be collected on Day 1: 1hr predose; 0,25h; 0,5h; 1h; 1,5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h post dose, on Day 2: 24h and 36h post dose, on Day 3: 48h and 60h post dose and on Day 4: 72h post dose. This outcome measure shows the mean of all subject values resulting from each time point specified above, in Parts 1 and 3. In Part 3, the outcome measure is done once without food intake and once after the intake of a high fat breakfast (in 2 different periods). Both outcomes (with and without breakfast intake) will be compared to assess the effect of a high fast breakfast on LML134 AUClast.
Measured: Starting 1hour prior to dosing on Day 1 and until 72 hours after dosing (Day 4)
PK of LML134: time to reach the maximum concentration after the first drug administration (Tmax) in Part 2
Serum samples will be collected on Day 1: 1hr predose; 0,25h; 0,5h; 1h; 1,5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h post dose and on Day 2: 24h post dose. This outcome measure shows the mean of all subject values resulting from each time point specified above.
Measured: Starting 1hour prior the first dose administration (Day 1) until 24hr after the first dose administration on Day 2
PK of LML134: time to reach the maximum concentration after the last drug administration (Tmax) in Part 2
Serum samples will be collected on Day 1: 1hr predose; 0,25h; 0,5h; 1h; 1,5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h post dose, on Day 2: 24h post dose, on Day 3: 1hr prior the second dose administration, on Days 4, 5, 6, 8, 10, 12, 13, 14: 1hr prior dosing, on Day 15 (last time the drug is administered): 1hr predose; 0,25h; 0,5h; 1h; 1,5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h post dose, on Day 16: 24h post dose and Day 17: 48h post dose. This outcome measure shows the mean of all subject values resulting from each time point specified above.
Measured: Starting 1hour prior the first dose administration (Day 1) until 48hour after the last dose administration (Day 17)
PK of LML134: Observed maximum serum concentration following the first drug administration (Cmax) in Part 2
Serum samples will be collected on Day 1: 1hr predose; 0,25h; 0,5h; 1h; 1,5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h post dose and on Day 2: 24h post dose. This outcome measure shows the mean of all subject values resulting from each time point specified above.
Measured: Starting 1hour prior the first dose administration (Day 1) until 24hr after the first dose administration on Day 2
PK of LML134: Observed maximum serum concentration following drug administration at steady state (Cmax,ss) in Part 2
Serum samples will be collected on Day 1: 1hr predose; 0,25h; 0,5h; 1h; 1,5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h post dose, on Day 2: 24h post dose, on Day 3: 1hr prior the second dose administration, on Days 4, 5, 6, 8, 10, 12, 13, 14: 1hr prior dosing, on Day 15 (last time the drug is administered): 1hr predose; 0,25h; 0,5h; 1h; 1,5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h post dose, on Day 16: 24h post dose and Day 17: 48h post dose. This outcome measure shows the mean of all subject values resulting from each time point specified above.
Measured: Starting 1hour prior the first dose administration (Day 1) until 48hour after the last dose administration (Day 17)
PK of LML134: Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) after the first dose administration in Part 2
Serum samples will be collected on Day 1: 1hr predose; 0,25h; 0,5h; 1h; 1,5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h post dose and on Day 2: 24h post dose. This outcome measure shows the mean of all subject values resulting from each time point specified above.
Measured: Starting 1hour prior the first dose administration (Day 1) until 24hr after the first dose administration on Day 2
PK of LML134: The area under the serum concentration-time curve from time zero to the end of the dosing interval tau at steady state (AUCtau,ss) in Part 2
Serum samples will be collected on Day 1: 1hr predose; 0,25h; 0,5h; 1h; 1,5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h post dose, on Day 2: 24h post dose, on Day 3: 1hr prior the second dose administration, on Days 4, 5, 6, 8, 10, 12, 13, 14: 1hr prior dosing, on Day 15 (last time the drug is administered): 1hr predose; 0,25h; 0,5h; 1h; 1,5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h post dose, on Day 16: 24h post dose and Day 17: 48h post dose. This outcome measure shows the mean of all subject values resulting from each time point specified above.
Measured: Starting 1hour prior the first dose administration (Day 1) until 48hour after the last dose administration (Day 17)
PK of LML134: The average steady state serum concentration during multiple dosing (Cav,ss) in Part 2
Serum samples will be collected on Day 1: 1hr predose; 0,25h; 0,5h; 1h; 1,5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h post dose, on Day 2: 24h post dose, on Day 3: 1hr prior the second dose administration, on Days 4, 5, 6, 8, 10, 12, 13, 14: 1hr prior dosing, on Day 15 (last time the drug is administered): 1hr predose; 0,25h; 0,5h; 1h; 1,5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h post dose, on Day 16: 24h post dose and Day 17: 48h post dose. This outcome measure shows the mean of all subject values resulting from each time point specified above.
Measured: Starting 1hour prior the first dose administration (Day 1) until 48hour after the last dose administration (Day 17)
PK of LML134: The effective half-life based on drug accumulation at steady state (T1/2,acc) in Part 2
Serum samples will be collected on Day 1: 1hr predose; 0,25h; 0,5h; 1h; 1,5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h post dose, on Day 2: 24h post dose, on Day 3: 1hr prior the second dose administration, on Days 4, 5, 6, 8, 10, 12, 13, 14: 1hr prior dosing, on Day 15 (last time the drug is administered): 1hr predose; 0,25h; 0,5h; 1h; 1,5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h post dose, on Day 16: 24h post dose and Day 17: 48h post dose. This outcome measure shows the mean of all subject values resulting from each time point specified above.
Measured: Starting 1hour prior the first dose administration (Day 1) until 48hour after the last dose administration (Day 17)
PK of LML134: The accumulation ratio (Racc) in Part 2
Serum samples will be collected on Day 1: 1hr predose; 0,25h; 0,5h; 1h; 1,5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h post dose, on Day 2: 24h post dose, on Day 3: 1hr prior the second dose administration, on Days 4, 5, 6, 8, 10, 12, 13, 14: 1hr prior dosing, on Day 15 (last time the drug is administered): 1hr predose; 0,25h; 0,5h; 1h; 1,5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h post dose, on Day 16: 24h post dose and Day 17: 48h post dose. This outcome measure shows the mean of all subject values resulting from each time point specified above.
Measured: Starting 1hour prior the first dose administration (Day 1) until 48hour after the last dose administration (Day 17)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Treatment
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Novartis Pharmceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334449
- Sponsor's protocol ID
- CLML134X2101
- Other IDs
- 2014-000937-22, 2014
- Acronym
- LML134
- Status last verified
- Oct 2016
- First submitted
- 14 Nov 2014
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Oral Dose Study, to Assess the Safety, Tolerability and Pharmacokinetics of LML134 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02334449
- Acronym / sponsor ID
- LML134 / CLML134X2101
- Conditions
- Healthy Volunteers
- Keywords
- healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 Jan 2015 (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.
Phase I study to assess the safety, tolerability and pharmacokinetics of ascending single and multiple doses of the investigational medicinal product in healthy volunteers
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single dose study part | Experimental | Drug: LML134, Drug: Placebothere will be 8 cohorts of healthy volunteers dosed with single doses of LML134 (8 planned dose levels) or with placebo and 2 potential additional cohorts (also dosed with single dose of LML134 or placebo) |
| Multiple dose study part | Experimental | Drug: LML134, Drug: Placebothere will be 3 cohorts of healthy volunteers dosed with multiple doses of LML134 (3 planned dose levels) or placebo and one potential additional cohort (also dosed with multiple doses of LML134 or placebo) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female subjects age 18 to 55 years of age included, and in good health as determined by medical history, physical examination, vital signs, electrocardiogram, and laboratory tests.
- Written informed consent must be obtained before any assessment is performed.
- Able to communicate well with the Investigator, to understand and comply with the requirements of the study.
Key exclusion criteria (9 listed)
- History or presence of epilepsy or of seizures or convulsions of any kind.
- Any clinically relevant abnormalities identified in the resting EEG during screening, or pre-ictal signs or other clinically relevant abnormalities in the hyperventilation or intermittent photic stimulation EEG during screening.
- History of head trauma leading to clinically significant symptoms in the past two years.
- Applies only to subjects enrolled in Part 2 MAD. Score "yes" on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years.
- Significant illness including any clinically significant infectious disease which has not resolved within two (2) weeks prior to initial dosing.
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 |
|---|---|---|
| LML134LML134 will be administered first as single doses and then as multiple doses | Drug | Multiple dose study part, Single dose study part |
| PlaceboAll study cohorts (except food effect cohort) are placebo controlled | Drug | Multiple dose study part, Single dose study part |
Primary outcome
Adverse events assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion
Time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
This safety outcome combines the measure of the number of subjects experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatments.
Cardiovascular safety assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion
Time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
This safety outcome combines the measure of a set of cardiovascular safety parameters extracted from ECGs, 25 hours-Holter ECGs and from vital signs assessments
Central nervous system safety assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion
Time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
This safety outcome combines the measure of a set of central nervous system safety parameters extracted from EEGs and neurological examinations
Ocular safety assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion
Time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
This safety outcome combined the measure of a set of ocular parameters including best corrected visual acuity and other parameters assessed by the mean of slit lamp biomicroscopy and dilated ophthalmoscopy examinations and by optical coherence tomography and electroretinography
General safety assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion
Time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
This general safety outcome combines the measure of blood laboratory parameters and the outcome of physical examinations
12 secondary outcomes
Pharmacokinetics (PK) of LML134: time to reach the maximum concentration after a single drug administration (Tmax) in Part 1 and in Part 3
Time frame: Starting 1hour prior to dosing on Day 1 and until 72 hours after dosing (Day 4)
PK of LML134: Observed maximum serum concentration following single drug administration (Cmax) in Part 1 and Part 3
Time frame: Starting 1hour prior to dosing on Day 1 and until 72 hours after dosing (Day 4)
PK of LML134: Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) in Part 1 and Part 3
Time frame: Starting 1hour prior to dosing on Day 1 and until 72 hours after dosing (Day 4)
PK of LML134: time to reach the maximum concentration after the first drug administration (Tmax) in Part 2
Time frame: Starting 1hour prior the first dose administration (Day 1) until 24hr after the first dose administration on Day 2
PK of LML134: time to reach the maximum concentration after the last drug administration (Tmax) in Part 2
Time frame: Starting 1hour prior the first dose administration (Day 1) until 48hour after the last dose administration (Day 17)
PK of LML134: Observed maximum serum concentration following the first drug administration (Cmax) in Part 2
Time frame: Starting 1hour prior the first dose administration (Day 1) until 24hr after the first dose administration on Day 2
PK of LML134: Observed maximum serum concentration following drug administration at steady state (Cmax,ss) in Part 2
Time frame: Starting 1hour prior the first dose administration (Day 1) until 48hour after the last dose administration (Day 17)
PK of LML134: Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) after the first dose administration in Part 2
Time frame: Starting 1hour prior the first dose administration (Day 1) until 24hr after the first dose administration on Day 2
PK of LML134: The area under the serum concentration-time curve from time zero to the end of the dosing interval tau at steady state (AUCtau,ss) in Part 2
Time frame: Starting 1hour prior the first dose administration (Day 1) until 48hour after the last dose administration (Day 17)
PK of LML134: The average steady state serum concentration during multiple dosing (Cav,ss) in Part 2
Time frame: Starting 1hour prior the first dose administration (Day 1) until 48hour after the last dose administration (Day 17)
PK of LML134: The effective half-life based on drug accumulation at steady state (T1/2,acc) in Part 2
Time frame: Starting 1hour prior the first dose administration (Day 1) until 48hour after the last dose administration (Day 17)
PK of LML134: The accumulation ratio (Racc) in Part 2
Time frame: Starting 1hour prior the first dose administration (Day 1) until 48hour after the last dose administration (Day 17)
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 27 Oct 2016.
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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.
Study Director study director
Novartis Pharmceuticals
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 LML134 in people with Healthy Volunteers, run by Novartis Pharmaceuticals 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 3 inclusion and 9 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 27 Oct 2016. 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. 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?
Adverse events assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion (time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose). The study lists 5 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 27 Oct 2016.