Healthy Study ParticipantsPhase 1NCT04782388
Study to Assess the Safety, Tolerability, And Pharmacokinetics of Staccato Alprazolam in Healthy Japanese, Chinese, and Caucasian Participants
A Phase 1 study testing Alprazolam in people with Healthy Study Participants, run by UCB Biopharma SRL at 1 site in United States.
Trial summary
The purpose of the study is to assess the safety, tolerability, and pharmacokinetics (PK) of Staccato alprazolam in healthy Japanese, Chinese, and Caucasian participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Study Participants
- What is being tested?
- Alprazolam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2021to 26 Apr 2021
- 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
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent form (ICF)
- Participants are overtly healthy as determined by medical evaluation including medical history and physical examination
- For Japanese: Participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a participant has all 4 Japanese grandparents born in Japan) For Chinese: Participant is of Chinese descent as evidenced by appearance and verbal confirmation of familial heritage (a participant has all 4 Chinese grandparents born in China)
- Participant has a body weight (BW) of at least 45 kg (female) and 50 kg (male) and body mass index (BMI) within the range 18 to 30 kg/m^2(inclusive)
Who cannot join
- Participant has any medical or psychiatric condition that, in the opinion of the Investigator,could jeopardize or would compromise the study participant's ability to participate in this study
- Participant has a history or present condition of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders (eg, cardiac insufficiency, coronary heart disease, hypertension, arrhythmia, tachyarrhythmia, or myocardial infarction) capable of significantly altering the absorption, metabolism, or elimination of investigational medicinal product (IMP); constituting a risk when taking the study intervention; or interfering with the interpretation of data
- Participant has abnormal blood pressure (BP). Study participants must have BP and heart rate (HR) within normal range in the supine position after 5 minutes rest (systolic blood pressure (SBP): 90 mmHg to 140 mmHg, diastolic blood pressure (DBP): 50 mmHg to 90 mmHg, HR: 50 bpm to 100 bpm). Any values marginally (ie, no more than 5mmHg) outside the normal range but considered not clinically significant by the Investigator would be allowed. In case of an out-of-range result, 1 repeat will be allowed. If the readings are out of range again, the study participant will not be included
- Participant has a current history of alcohol or drug use disorder, as defined in Diagnostic and Statistical Manual of Mental Disorders V, within the previous 6 months
- Participant has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Screening/Baseline" version of the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening
- Participant has history of or current clinical signs/symptoms consistent with suspected and/or confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)/coronavirus disease 2019 (COVID-19) (eg, fever, persistent cough, shortness of breath, fatigue, loss or change to senses of smell or taste)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo-Controlled, Double-blind, Randomized Study to Assess the Safety, Tolerability, And Pharmacokinetics of Staccato Alprazolam in Healthy Japanese, Chinese, and Caucasian Participants
The purpose of the study is to assess the safety, tolerability, and pharmacokinetics (PK) of Staccato alprazolam in healthy Japanese, Chinese, and Caucasian participants.
- Conditions
- Healthy Study Participants
- Being tested
- Alprazolam, Placebo
- Keywords
- Healthy Study Participants, Phase 1, Staccato alprazolam, Alprazolam, STAP-001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlprazolamDrug
Also called UCB7538
Study participants will receive Staccato alprazolam at prespecified time-point.
PlaceboOther
Also called PBO
Study participants will receive Staccato placebo at prespecified time-point.
| Study group | Role | What they receive |
|---|---|---|
| Staccato alprazolam | Experimental | Study participants will receive Single dose of Staccato alprazolam on Day 1 of the Treatment Period. Receives: Drug: Alprazolam |
| Staccato placebo | Placebo comparator | Study participants will receive placebo on Day 1 of the Treatment Period. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Japanese study participants with treatment-emergent adverse events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. The occurrence and incidence of TEAEs will also be summarized by intensity and by relationship to the investigational medicinal product (IMP).
Measured: From Baseline to the end of the Safety-Follow-Up (up to Day 10)
Percentage of Japanese study participants with serious adverse event (SAEs)
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:
- Results in death
- Is life-threatening
- Requires inpatient hospitalization or prolongation of existing hospitalization
- Results in persistent disability/incapacity
- Is a congenital anomaly/birth defect
- Important medical events refered in the Protocol.
Measured: From Baseline to the end of the Safety-Follow-Up (up to Day 10)
Percentage of Chinese study participants with treatment-emergent adverse events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. The occurrence and incidence of TEAEs will also be summarized by intensity and by relationship to the investigational medicinal product (IMP).
Measured: From Baseline to the end of the Safety-Follow-Up (up to Day 10)
Percentage of Chinese study participants with serious adverse events (SAEs)
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:
- Results in death
- Is life-threatening
- Requires inpatient hospitalization or prolongation of existing hospitalization
- Results in persistent disability/incapacity
- Is a congenital anomaly/birth defect
- Important medical events refered in the Protocol.
Measured: From Baseline to the end of the Safety-Follow-Up (up to Day 10)
Maximum plasma concentration (Cmax) of Staccato alprazolam in Japanese study participants
Cmax = Maximum plasma concentration.
Measured: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUClast) of Staccato alprazolam in Japanese study participants
AUClast = Area under the plasma concentration-time curve from time 0 to the last measurable concentration.
Measured: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Staccato alprazolam in Japanese study participants
AUCinf = Area under the plasma concentration-time curve from time 0 to infinity.
Measured: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
Maximum plasma concentration (Cmax) of Staccato alprazolam in Chinese study participants
Cmax = Maximum plasma concentration.
Measured: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUClast) of Staccato alprazolam in Chinese study participants
AUClast = Area under the plasma concentration-time curve from time 0 to the last measurable concentration.
Measured: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Staccato alprazolam in Chinese study participants
AUCinf = Area under the plasma concentration-time curve from time 0 to infinity.
Measured: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
Secondary outcomes (3)
Maximum plasma concentration (Cmax) of Staccato alprazolam in Caucasian study participants
Cmax = Maximum plasma concentration.
Measured: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUClast) of Staccato alprazolam in Caucasian study participants
AUClast = Area under the plasma concentration-time curve from time 0 to the last measurable concentration.
Measured: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Staccato alprazolam in Caucasian study participants
AUCinf = Area under the plasma concentration-time curve from time 0 to infinity.
Measured: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start4 Mar 2021
- Primary completion26 Apr 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Study ParticipantsStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782388
- Sponsor's protocol ID
- UP0101
- Status last verified
- May 2021
- First submitted
- 1 Mar 2021
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Double-blind, Randomized Study to Assess the Safety, Tolerability, And Pharmacokinetics of Staccato Alprazolam in Healthy Japanese, Chinese, and Caucasian Participants
- ClinicalTrials.gov ID
- NCT04782388
- Acronym / sponsor ID
- UP0101
- Conditions
- Healthy Study Participants
- Keywords
- Healthy Study Participants, Phase 1, Staccato alprazolam, Alprazolam, STAP-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 4 Mar 2021 (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.
The purpose of the study is to assess the safety, tolerability, and pharmacokinetics (PK) of Staccato alprazolam in healthy Japanese, Chinese, and Caucasian participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Staccato alprazolam | Experimental | Drug: AlprazolamStudy participants will receive Single dose of Staccato alprazolam on Day 1 of the Treatment Period. |
| Staccato placebo | Placebo comparator | Other: PlaceboStudy participants will receive placebo on Day 1 of the Treatment Period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent form (ICF)
- Participants are overtly healthy as determined by medical evaluation including medical history and physical examination
- For Japanese: Participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a participant has all 4 Japanese grandparents born in Japan) For Chinese: Participant is of Chinese descent as evidenced by appearance and verbal confirmation of familial heritage (a participant has all 4 Chinese grandparents born in China)
- Participant has a body weight (BW) of at least 45 kg (female) and 50 kg (male) and body mass index (BMI) within the range 18 to 30 kg/m^2(inclusive)
Key exclusion criteria (6 listed)
- Participant has any medical or psychiatric condition that, in the opinion of the Investigator,could jeopardize or would compromise the study participant's ability to participate in this study
- Participant has a history or present condition of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders (eg, cardiac insufficiency, coronary heart disease, hypertension, arrhythmia, tachyarrhythmia, or myocardial infarction) capable of significantly altering the absorption, metabolism, or elimination of investigational medicinal product (IMP); constituting a risk when taking the study intervention; or interfering with the interpretation of data
- Participant has abnormal blood pressure (BP). Study participants must have BP and heart rate (HR) within normal range in the supine position after 5 minutes rest (systolic blood pressure (SBP): 90 mmHg to 140 mmHg, diastolic blood pressure (DBP): 50 mmHg to 90 mmHg, HR: 50 bpm to 100 bpm). Any values marginally (ie, no more than 5mmHg) outside the normal range but considered not clinically significant by the Investigator would be allowed. In case of an out-of-range result, 1 repeat will be allowed. If the readings are out of range again, the study participant will not be included
- Participant has a current history of alcohol or drug use disorder, as defined in Diagnostic and Statistical Manual of Mental Disorders V, within the previous 6 months
- Participant has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Screening/Baseline" version of the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening
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 |
|---|---|---|
| AlprazolamAlso: UCB7538Study participants will receive Staccato alprazolam at prespecified time-point. | Drug | Staccato alprazolam |
| PlaceboAlso: PBOStudy participants will receive Staccato placebo at prespecified time-point. | Other | Staccato placebo |
Primary outcome
Percentage of Japanese study participants with treatment-emergent adverse events (TEAEs)
Time frame: From Baseline to the end of the Safety-Follow-Up (up to Day 10)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. The occurrence and incidence of TEAEs will also be summarized by intensity and by relationship to the investigational medicinal product (IMP).
Percentage of Japanese study participants with serious adverse event (SAEs)
Time frame: From Baseline to the end of the Safety-Follow-Up (up to Day 10)
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: 1. Results in death 2. Is life-threatening 3. Requires inpatient hospitalization or prolongation of existing hospitalization 4. Results in persistent disability/incapacity 5. Is a congenital anomaly/birth defect 6. Important medical events refered in the Protocol.
Percentage of Chinese study participants with treatment-emergent adverse events (TEAEs)
Time frame: From Baseline to the end of the Safety-Follow-Up (up to Day 10)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. The occurrence and incidence of TEAEs will also be summarized by intensity and by relationship to the investigational medicinal product (IMP).
Percentage of Chinese study participants with serious adverse events (SAEs)
Time frame: From Baseline to the end of the Safety-Follow-Up (up to Day 10)
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: 1. Results in death 2. Is life-threatening 3. Requires inpatient hospitalization or prolongation of existing hospitalization 4. Results in persistent disability/incapacity 5. Is a congenital anomaly/birth defect 6. Important medical events refered in the Protocol.
Maximum plasma concentration (Cmax) of Staccato alprazolam in Japanese study participants
Time frame: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
Cmax = Maximum plasma concentration.
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUClast) of Staccato alprazolam in Japanese study participants
Time frame: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
AUClast = Area under the plasma concentration-time curve from time 0 to the last measurable concentration.
Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Staccato alprazolam in Japanese study participants
Time frame: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
AUCinf = Area under the plasma concentration-time curve from time 0 to infinity.
Maximum plasma concentration (Cmax) of Staccato alprazolam in Chinese study participants
Time frame: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
Cmax = Maximum plasma concentration.
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUClast) of Staccato alprazolam in Chinese study participants
Time frame: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
AUClast = Area under the plasma concentration-time curve from time 0 to the last measurable concentration.
Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Staccato alprazolam in Chinese study participants
Time frame: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
AUCinf = Area under the plasma concentration-time curve from time 0 to infinity.
3 secondary outcomes
Maximum plasma concentration (Cmax) of Staccato alprazolam in Caucasian study participants
Time frame: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUClast) of Staccato alprazolam in Caucasian study participants
Time frame: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Staccato alprazolam in Caucasian study participants
Time frame: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
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 17 May 2021.
- Individual participant dataSharing planned: No. Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
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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.
UCB Cares study director
001 844 599 2273 (UCB)
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 Alprazolam in people with Healthy Study Participants, run by UCB Biopharma SRL at 1 site in United States.
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 17 May 2021. 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 United States. 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?
Percentage of Japanese study participants with treatment-emergent adverse events (TEAEs) (time frame: From Baseline to the end of the Safety-Follow-Up (up to Day 10)). 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 17 May 2021.