HealthyPhase 1NCT04693455
ZD03 Capsule Study
A Phase 1 study testing ZD03 in people with Healthy, run by Shanxi Zhendong Leading Biotechnology Co., Ltd. at 1 site in United States.
Trial summary
This is a Phase 1, Double Blind, Randomized, Placebo Controlled, Single Dose, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZD03 Capsule in Healthy Volunteers in The United States Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ZD03
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2019to 27 Apr 2020
- 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
- Male or female volunteers aged 18 to 55 years, inclusive.
- An attempt will be made to recruit at least 50% non-Hispanic Caucasians in each cohort,Healthy (no clinically significant health concerns), as determined by medical history, physical examination, 12-lead ECG, and vital signs at screening.
- Subjects must have a Body Mass Index (BMI) between 18.0 and 30.0 kg/m2 at screening (inclusive) and weighed a minimum of 50 kg (110 lbs).
- Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal ligation, Essure procedure, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or postmenopausal for ≥ 12 months. The site will attempt to retrieve medical records to document sterility; however, the absence of records will not exclude screening the subject. If medical records cannot be obtained, a negative pregnancy test at screening will be accepted. Postmenopausal status will be confirmed through testing of FSH (follicle stimulating hormone) levels by PI discretion at screening for amenorrhoeic female subjects.
- Males must be surgically sterile (> 30 days since vasectomy with no viable sperm), abstinent or if engaged in sexual relations with a female partner of child-bearing potential, the subject must be using a condom with spermicide from Screening and for a period of 30 days after the last dose of Study Drug.
- Acceptable methods of contraception for males are condoms with spermicide.
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- Subjects must have a complete blood count (CBC) and platelet count within the normal range or considered not clinically significant by the PI.
- Subjects must have normal blood chemistry or results considered not clinically significant by the investigator including electrolytes (Na+, K+, Ca++, and Cl-), alkaline phosphatase, total protein, albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, uric acid, creatinine, blood urea nitrogen (BUN), and glucose.
- Subjects must have a normal urinalysis or results considered not clinically significant by the investigator including a normal protein/creatinine ratio per local lab reference ranges (< 200 mg/g) and a urine creatinine result that does not exceed 300 mg/dL.
- Subjects must have estimated glomerular filtration rate (eGFR) ≥ 90 mL/min(Based on MDRD).
- Subjects must have a normal ECG or results considered not clinically significant by the PI.
- Subjects must be able to comply with the study and follow-up procedures.
- Subjects are able to understand the study procedures and risks involved and must provide signed informed consent to participate in the study
Who cannot join
- Subjects with any history or clinical manifestations of significant metabolic, hematological, pulmonary, including latent tuberculosis, cardiovascular, gastrointestinal including cholecystectomy, neurologic, hepatic, renal, urological, or psychiatric disorders.
- Subjects who have any history or suspicion of kidney stones.
- Subjects who are positive for human immunodeficiency virus (HIV), Hepatitis B surface antigen, Hepatitis C virus, and/or treponema pallidum.
- Subjects who have used prescription drugs, over-the-counter drugs, or herbal remedies within 14 days before Day 1 of study medication dosing. Females who have received hormone replacement therapy (HRT) within 28 days prior to dosing.
- Subjects who have undergone major surgery within 3 months prior to Day 1.
- Women who are pregnant or breastfeeding.
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- Subjects who received any investigational test article within 5 half-lives or 30 days, whichever is longer, prior to Day 1 study medication dosing.
- Subjects who consumed Seville oranges or grapefruit containing foods or beverages within 7 days before Day 1 and during the entire study duration.
- Subjects who had been treated with any known drugs that are moderate or strong inhibitors/inducers of cytochrome P450 (CYP) enzymes such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication and that in the Investigator's judgment may have impacted subject safety or the validity of the study results.
- Subjects who had a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates) or cotinine.
- Subjects with any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Worldwide Clinical Trials,Early Phase Services, LLC
San Antonio, Texas, 78217
About this study
Official title: A Phase 1, Double Blind, Randomized, Placebo Controlled, Single Dose, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZD03 Capsule in Healthy Volunteers in The United States
This is a Phase 1, Double Blind, Randomized, Placebo Controlled, Single Dose, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZD03 Capsule in Healthy Volunteers in The United States
Read the detailed description
ZD03 is a novel small molecular drug. It is a synthetic chemical drug candidate for treatment of multiple sclerosis (MS) and is proposed to be administered orally as capsules.
This is a double-blind, randomized, placebo-controlled, single ascending dose study. Approximately 56 HVs will enter into the phase 1 study. The study is designed to evaluate the safety,tolerability and PK of ZD03 capsule at different dose cohorts when administered orally.
Subjects who meet the enrollment criteria will be enrolled in one of the seven dose levels designated for the study, including the doses of 20, 40, 80, 120, 180, 240 and 300 mg (doses escalated by 100%, 100%, 50%, 50%, 33% and 25%, respectively). Each cohort will consist of 8 subjects randomized at 3:1 to receive a single oral dose of ZD03 (n=6) or placebo (n=2) in a double-blind manner in a fasted state
- Conditions
- Healthy
- Being tested
- ZD03, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZD03Drug
ZD03 capsule
PlaceboOther
placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Cohort 1, Dose 1 of ZD03 or Placebo | Experimental | Dose 1 of ZD03 or matching Placebo capsules by mouth Receives: Drug: ZD03; Other: Placebo |
| Experimental: Cohort 2, Dose 2 of ZD03 or Placebo | Experimental | Dose 2 of ZD03 or matching Placebo capsules by mouth Receives: Drug: ZD03; Other: Placebo |
| Experimental: Cohort 3, Dose 3 of ZD03 or Placebo | Experimental | Dose 3 of ZD03 or matching Placebo capsules by mouth Receives: Drug: ZD03; Other: Placebo |
| Experimental: Cohort 4, Dose 4 of ZD03 or Placebo | Experimental | Dose 4 of ZD03 or matching Placebo capsules by mouth Receives: Drug: ZD03; Other: Placebo |
| Experimental: Cohort 5, Dose 5 of ZD03 or Placebo | Experimental | Dose 5 of ZD03 or matching Placebo capsules by mouth Receives: Drug: ZD03; Other: Placebo |
| Experimental: Cohort 6, Dose 6 of ZD03 or Placebo | Experimental | Dose 6 of ZD03 or matching Placebo capsules by mouth Receives: Drug: ZD03; Other: Placebo |
| Experimental: Cohort 7, Dose 7 of ZD03 or Placebo | Experimental | Dose 7 of ZD03 or matching Placebo capsules by mouth Receives: Drug: ZD03; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability
Safety and tolerability will be assessed by monitoring adverse events (AEs), several adverse events (SAEs)
Measured: Up to 14 days
Number of participants with clinically significant Vital sign abnormalities will be assessed by Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1
Assessed as number of participants with clinically significant changes from Baseline, compared across arms. Vital signs including sitting blood pressure, pulse rate, respiration rate and oral temperature.
Measured: Screening, Day -1 to Day 1, Day 2 and Day 7
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities will be assessed by Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1
Assessed as number of participants with clinically significant changes from Baseline, compared across arms. Resting 12-lead ECGs will use a standard 12-lead ECG machine that automatically calculates HR and measures RR, PR, QRS, QT and QTc intervals.
Measured: Screening, Day -1 to Day 1, Day 2 and Day 7
Number of participants with clinically significant physical examination abnormalities will be assessed by discretion of the investigator
Assessed as number of participants with clinically significant changes from Baseline, compared across arms. Physical examination including the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes and extremities.
Measured: Screening, Day -1 to Day 1, Day 2 and Day 7
Number of participants with clinically significant haematology assessment abnormalities will be assessed by Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1
Assessed as number of participants with clinically significant changes from Baseline, compared across arms. Haematology including Basophils (abs), Eosinophils (abs), Hemoglobin, Monocytes (abs), Neutrophils (abs), Platelets, RBC and WBC, etc.
Measured: Screening, Day -1 to Day 1, Day 2 and Day 7
Number of participants with clinically significant serum chemistry assessment abnormalities will be assessed by Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1
Assessed as number of participants with clinically significant changes from Baseline, compared across arms. Serum chemistry including Magnesium, Albumin, Phosphorus, Potassium, Sodium, Total Bilirubin, Total Protein, and Triglyceride, etc.
Measured: Screening, Day -1 to Day 1, Day 2 and Day 7
Number of participants with clinically significant urinalysis assessment abnormalities will be assessed by Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1
Assessed as number of participants with clinically significant changes from Baseline, compared across arms. Urinalysis including Bilirubin, Clarity, Color, Glucose, Ketone, Leukocyte, esterase, Protein, Specific, gravity, and Urobilinogen, etc.
Measured: Screening, Day -1 to Day 1, Day 2 and Day 7
Secondary outcomes (7)
PK parameters-AUC0-t
area under the concentration-time curve from time 0 to the time of last quantifiable concentration (tlast), calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations
Measured: Up to 24 hours
PK parameters-AUC0-∞
area under the concentration-time curve from time 0 extrapolated to infinity
Measured: Up to 24 hours
PK parameters-Cmax
maximum observed plasma concentration
Measured: Up to 24 hours
PK parameters-tmax
time of maximum observed plasma concentration
Measured: Up to 24 hours
PK parameters-t1/2
apparent plasma terminal elimination half-life
Measured: Up to 24 hours
PK parameters-CL/F
apparent total plasma clearance
Measured: Up to 24 hours
PK parameters-Vz/F
apparent volume of distribution during the terminal elimination phase
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start6 Nov 2019
- Primary completion27 Apr 2020
- Study completion27 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanxi Zhendong Leading Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693455
- Sponsor's protocol ID
- ZDXD-ZD03-US-19-4
- Status last verified
- Nov 2020
- First submitted
- 1 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double Blind, Randomized, Placebo Controlled, Single Dose, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZD03 Capsule in Healthy Volunteers in The United States
- ClinicalTrials.gov ID
- NCT04693455
- Acronym / sponsor ID
- ZDXD-ZD03-US-19-4
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Shanxi Zhendong Leading Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 27 Apr 2020 (actual)
- Study completion
- 27 Apr 2020 (actual)
- First posted
- 5 Jan 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.
This is a Phase 1, Double Blind, Randomized, Placebo Controlled, Single Dose, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZD03 Capsule in Healthy Volunteers in The United States
Detailed description
ZD03 is a novel small molecular drug. It is a synthetic chemical drug candidate for treatment of multiple sclerosis (MS) and is proposed to be administered orally as capsules.
This is a double-blind, randomized, placebo-controlled, single ascending dose study. Approximately 56 HVs will enter into the phase 1 study. The study is designed to evaluate the safety,tolerability and PK of ZD03 capsule at different dose cohorts when administered orally.
Subjects who meet the enrollment criteria will be enrolled in one of the seven dose levels designated for the study, including the doses of 20, 40, 80, 120, 180, 240 and 300 mg (doses escalated by 100%, 100%, 50%, 50%, 33% and 25%, respectively). Each cohort will consist of 8 subjects randomized at 3:1 to receive a single oral dose of ZD03 (n=6) or placebo (n=2) in a double-blind manner in a fasted state
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Experimental: Cohort 1, Dose 1 of ZD03 or Placebo | Experimental | Drug: ZD03, Other: PlaceboDose 1 of ZD03 or matching Placebo capsules by mouth |
| Experimental: Cohort 2, Dose 2 of ZD03 or Placebo | Experimental | Drug: ZD03, Other: PlaceboDose 2 of ZD03 or matching Placebo capsules by mouth |
| Experimental: Cohort 3, Dose 3 of ZD03 or Placebo | Experimental | Drug: ZD03, Other: PlaceboDose 3 of ZD03 or matching Placebo capsules by mouth |
| Experimental: Cohort 4, Dose 4 of ZD03 or Placebo | Experimental | Drug: ZD03, Other: PlaceboDose 4 of ZD03 or matching Placebo capsules by mouth |
| Experimental: Cohort 5, Dose 5 of ZD03 or Placebo | Experimental | Drug: ZD03, Other: PlaceboDose 5 of ZD03 or matching Placebo capsules by mouth |
| Experimental: Cohort 6, Dose 6 of ZD03 or Placebo | Experimental | Drug: ZD03, Other: PlaceboDose 6 of ZD03 or matching Placebo capsules by mouth |
| Experimental: Cohort 7, Dose 7 of ZD03 or Placebo | Experimental | Drug: ZD03, Other: PlaceboDose 7 of ZD03 or matching Placebo capsules by mouth |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Male or female volunteers aged 18 to 55 years, inclusive.
- An attempt will be made to recruit at least 50% non-Hispanic Caucasians in each cohort,Healthy (no clinically significant health concerns), as determined by medical history, physical examination, 12-lead ECG, and vital signs at screening.
- Subjects must have a Body Mass Index (BMI) between 18.0 and 30.0 kg/m2 at screening (inclusive) and weighed a minimum of 50 kg (110 lbs).
- Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal ligation, Essure procedure, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or postmenopausal for ≥ 12 months. The site will attempt to retrieve medical records to document sterility; however, the absence of records will not exclude screening the subject. If medical records cannot be obtained, a negative pregnancy test at screening will be accepted. Postmenopausal status will be confirmed through testing of FSH (follicle stimulating hormone) levels by PI discretion at screening for amenorrhoeic female subjects.
- Males must be surgically sterile (> 30 days since vasectomy with no viable sperm), abstinent or if engaged in sexual relations with a female partner of child-bearing potential, the subject must be using a condom with spermicide from Screening and for a period of 30 days after the last dose of Study Drug.
Key exclusion criteria (11 listed)
- Subjects with any history or clinical manifestations of significant metabolic, hematological, pulmonary, including latent tuberculosis, cardiovascular, gastrointestinal including cholecystectomy, neurologic, hepatic, renal, urological, or psychiatric disorders.
- Subjects who have any history or suspicion of kidney stones.
- Subjects who are positive for human immunodeficiency virus (HIV), Hepatitis B surface antigen, Hepatitis C virus, and/or treponema pallidum.
- Subjects who have used prescription drugs, over-the-counter drugs, or herbal remedies within 14 days before Day 1 of study medication dosing. Females who have received hormone replacement therapy (HRT) within 28 days prior to dosing.
- Subjects who have undergone major surgery within 3 months prior to Day 1.
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 |
|---|---|---|
| ZD03ZD03 capsule | Drug | Experimental: Cohort 1, Dose 1 of ZD03 or Placebo, Experimental: Cohort 2, Dose 2 of ZD03 or Placebo, Experimental: Cohort 3, Dose 3 of ZD03 or Placebo, Experimental: Cohort 4, Dose 4 of ZD03 or Placebo, Experimental: Cohort 5, Dose 5 of ZD03 or Placebo, Experimental: Cohort 6, Dose 6 of ZD03 or Placebo, Experimental: Cohort 7, Dose 7 of ZD03 or Placebo |
| Placeboplacebo capsule | Other | Experimental: Cohort 1, Dose 1 of ZD03 or Placebo, Experimental: Cohort 2, Dose 2 of ZD03 or Placebo, Experimental: Cohort 3, Dose 3 of ZD03 or Placebo, Experimental: Cohort 4, Dose 4 of ZD03 or Placebo, Experimental: Cohort 5, Dose 5 of ZD03 or Placebo, Experimental: Cohort 6, Dose 6 of ZD03 or Placebo, Experimental: Cohort 7, Dose 7 of ZD03 or Placebo |
Primary outcome
safety and tolerability
Time frame: Up to 14 days
Safety and tolerability will be assessed by monitoring adverse events (AEs), several adverse events (SAEs)
Number of participants with clinically significant Vital sign abnormalities will be assessed by Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1
Time frame: Screening, Day -1 to Day 1, Day 2 and Day 7
Assessed as number of participants with clinically significant changes from Baseline, compared across arms. Vital signs including sitting blood pressure, pulse rate, respiration rate and oral temperature.
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities will be assessed by Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1
Time frame: Screening, Day -1 to Day 1, Day 2 and Day 7
Assessed as number of participants with clinically significant changes from Baseline, compared across arms. Resting 12-lead ECGs will use a standard 12-lead ECG machine that automatically calculates HR and measures RR, PR, QRS, QT and QTc intervals.
Number of participants with clinically significant physical examination abnormalities will be assessed by discretion of the investigator
Time frame: Screening, Day -1 to Day 1, Day 2 and Day 7
Assessed as number of participants with clinically significant changes from Baseline, compared across arms. Physical examination including the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes and extremities.
Number of participants with clinically significant haematology assessment abnormalities will be assessed by Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1
Time frame: Screening, Day -1 to Day 1, Day 2 and Day 7
Assessed as number of participants with clinically significant changes from Baseline, compared across arms. Haematology including Basophils (abs), Eosinophils (abs), Hemoglobin, Monocytes (abs), Neutrophils (abs), Platelets, RBC and WBC, etc.
Number of participants with clinically significant serum chemistry assessment abnormalities will be assessed by Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1
Time frame: Screening, Day -1 to Day 1, Day 2 and Day 7
Assessed as number of participants with clinically significant changes from Baseline, compared across arms. Serum chemistry including Magnesium, Albumin, Phosphorus, Potassium, Sodium, Total Bilirubin, Total Protein, and Triglyceride, etc.
Number of participants with clinically significant urinalysis assessment abnormalities will be assessed by Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1
Time frame: Screening, Day -1 to Day 1, Day 2 and Day 7
Assessed as number of participants with clinically significant changes from Baseline, compared across arms. Urinalysis including Bilirubin, Clarity, Color, Glucose, Ketone, Leukocyte, esterase, Protein, Specific, gravity, and Urobilinogen, etc.
7 secondary outcomes
PK parameters-AUC0-t
Time frame: Up to 24 hours
PK parameters-AUC0-∞
Time frame: Up to 24 hours
PK parameters-Cmax
Time frame: Up to 24 hours
PK parameters-tmax
Time frame: Up to 24 hours
PK parameters-t1/2
Time frame: Up to 24 hours
PK parameters-CL/F
Time frame: Up to 24 hours
PK parameters-Vz/F
Time frame: Up to 24 hours
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 5 Jan 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ZD03 in people with Healthy, run by Shanxi Zhendong Leading Biotechnology Co., Ltd. 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 13 inclusion and 11 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 5 Jan 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. 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?
safety and tolerability (time frame: Up to 14 days). The study lists 7 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 5 Jan 2021.