Ulcerative ColitisPhase 1NCT03597971
HMPL004-6599 Phase I Dose-escalating Study
A Phase 1 study testing HMPL004-6599 in people with Ulcerative Colitis and Crohn Disease, run by Nutrition Science Partners Limited at 1 site in Australia.
Trial summary
To assess the safety and tolerability of single and multiple doses of HMPL004-6599 in healthy male volunteers Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis, Crohn Disease
- What is being tested?
- HMPL004-6599
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 20 Mar 2018to 19 Nov 2018
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must meet all the following for inclusion in the trial:
- Informed consent must be obtained in writing for all subjects before enrollment into the study.
- Healthy male subjects aged 18 to 45 years inclusive at the time of screening.
- Body mass index ≥19.0 and ≤ 30.0 kg/m2
- No clinically significant abnormalities as determined by medical history and physical examination, especially with regard to the liver, bile and gastrointestinal systems.
- No clinically significant laboratory values and urinalysis, as determined by the Clinical Investigator.
- No clinically significant findings in ECG, blood pressure and heart rate, as determined by the Clinical Investigator.
- Willing to comply with the contraceptive requirements of the study and must not donate sperm during the study and for 3 months afterwards. Subjects must agree to use a condom or to abstain from sexual intercourse throughout the trial and for 3 months afterwards.
Who cannot join
- Subjects presenting with any of the following will not be included in the study:
- Family history of premature Coronary Heart Disease
- History of immunosuppression or opportunistic infections or receipt of a live virus vaccination within the 3 months prior to screening.
- Subjects at risk for tuberculosis (TB), specifically subjects with:
- Clinical or laboratory evidence of active TB
- History of active TB unless there is documentation that the prior anti-TB treatment was appropriate in duration and type
Show all 29Show fewer
- Latent TB which has not been successfully treated
- History of hypertension requiring treatment.
- Any condition requiring the regular use of any medication.
- Exposure to prescription medications within 30 days prior to Day 1.
- Exposure to any other medication, including over-the counter medications, herbal remedies and vitamins 14 days prior to first dose (except for paracetamol).
- Participation in another study with any investigational drug in the 30 days preceding Day 1 of the study or in the exclusion period of any previous study with investigational drugs.
- Treatment in the previous 3 months with any drug known to have a well-defined potential for toxicity to a major organ. Once-off medication such as paracetamol or any medication deemed not clinically significant by the principal investigator can be permitted.
- Current smoker of more than 10 cigarettes or equivalent / day during past 3 months prior to commencing the study and unable to completely stop smoking during the study.
- Symptoms of a clinically significant illness in the 3 months before the study.
- Presence or sequelae of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Chronic constipation or diarrhea, irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), Hemorrhoids or anal diseases with regular or recent presence of blood in feces.
- History of significant allergic disease (e.g. Allergic to medications) and acute phase of allergic rhinitis in the previous 2 weeks before randomization/enrollment or any food allergy.
- Blood or plasma donation of no more than 470 ml during the past 30 days (equivalent to the standard blood donation in Australia) before randomization/enrollment and/or more than 50 ml in the 2 weeks prior to screening.
- Known positive test for human immunodeficiency virus (HIV).
- Known positive test for hepatitis B or C, unless caused by immunization.
- Current evidence of drug abuse or history of drug abuse within one year before randomization/enrollment.
- History of alcohol abuse or active alcoholism with average weekly alcohol intake that exceeds 21 units.
- Mental condition rendering the subject incapable to understand the nature, scope, and possible consequences of the study.
- Adults under guardianship and people with restriction of freedom by administrative or legal decisions.
- Unlikely to comply with the clinical study protocol; e.g. uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study.
- Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
- Known allergy to plants of the Acanthaceae family.
- Those Subjects who are Vegetarian due to the requirements of the Standard Meal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double Blind, Placebo-controlled, Dose-escalating Study of the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of HMPL004-6599 in Healthy Male Volunteers
To assess the safety and tolerability of single and multiple doses of HMPL004-6599 in healthy male volunteers
Read the detailed description
This is a Phase I study with two parts:
Part A: Double blind, randomized, placebo-controlled, dose-escalating, single dose study in healthy volunteers.
Subjects will receive a single dose of up to 1800 mg HMPL004-6599 or matching placebo on Day 1. The planned dose levels are: 600, 1200, and 1800 mg under fed conditions with a standard meal, according to the randomization schedule. Dose levels may be repeated, or reduced if deemed appropriate by the Safety Monitoring Committee (SMC).
Part B: Double blind, randomized, placebo-controlled, dose-escalating, multiple dose study in healthy male volunteers.
Dose levels in Part B for 14 days are planned as 200mg TID, 400mg TID, 600mg BID and 600mg TID. These dose were jointly decided by the PI, SMC and the Sponsor based on the results from Part A. On day 14, only one dose in the morning will be administrated for all cohorts. Dose levels may be repeated, or reduced if deemed appropriate by the Safety Monitoring Committee (SMC).
In Part A, cohort 1 will consist of a blinded sentinel group of two subjects; one subject will receive HMPL004-6599 and the other will receive placebo, at least 24 hours prior to dosing the remaining 6 subjects in the cohort. The remaining subjects will only be dosed after review of available safety data from the sentinel subjects.
During Part A and Part B, PK sample collections will take place. During Part A, a full PK profile will be measured throughout Day 1. Samples will be collected from pre-dose to 24 hours post dose.
Part B PK sample collection is based on Part A study data. A full PK testing of plasma samples from pre-dose to 8 (TID) or 12 (BID) hours post dose will be collected on the first and last dosing days. Stool samples produced at baseline before dose and day 14-15 post last dose will be collected.
Concentrations of Andrographolide (AND), 14-deoxy-11,12- didehydroandrographolide (DDAND), HM5013620, neoandrographolide (NAND) and 14-deoxyandrographolide (DAND) in plasma (Part A and B) and fecal samples (Part B) will be determined for each dose level.
The plasma samples will be analyzed at the lab contracted by the Sponsor.
- Conditions
- Ulcerative Colitis, Crohn Disease
- Being tested
- HMPL004-6599, Placebo
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMPL004-6599Drug
For each cohort, 6 subjects will receive HMPL004-6599
PlaceboDrug
For each cohort, 2 subjects will receive placebo
| Study group | Role | What they receive |
|---|---|---|
| Part A: experimental | Experimental | Subjects will receive HMPL004-6599 or matching placebo on Day 1. This will be administered under fed conditions with a standard meal, according to the randomization schedule. Dose levels may be repeated, or reduced if deemed appropriate by the Safety Monitoring Committee (SMC). Receives: Drug: HMPL004-6599 |
| Part A: placebo | Placebo comparator | Subjects will receive matching placebo on Day 1. This will be administered under fed conditions with a standard meal, according to the randomization schedule. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
A primary objective of this study is to assess the safety of a single dose of up to 1800 mg in Part A (evaluated in planned steps of 600, 1200, and 1800 mg HMPL004-6599 under fed conditions of a standard meal), followed by multiple doses of up to 1800mg in Part B (evaluated in planned steps of 200mg TID, 400mg TID, 600mg BID and 600mg TID HMPL004-599 under fed conditions of a standard meal for 14 days ) in healthy male volunteers.
The occurrence of Serious Adverse Events and Adverse Events will be evaluated during the study in order to determine this primary objective.
Measured: Part A: single dose; Part B: 21 days
Incidence of Participants with Abnormal Laboratory Values
A further primary objective of this study is to assess the tolerability of a single dose of up to 1800 mg in Part A (evaluated in planned steps of 600, 1200, and 1800 mg HMPL004-6599 under fed conditions of a standard meal), followed by multiple doses of up to 1800mg in Part B (evaluated in planned steps of 200mg TID, 400mg TID, 600mg BID and 600mg TID HMPL004-599 under fed conditions of a standard meal for 14 days ) in healthy male volunteers.
The occurrence of abnormal laboratory values will be reviewed during the study in order to determine this primary objective.
Measured: Part A: single dose; Part B: 21 days
Secondary outcomes (10)
Maximum Plasma Concentration [Cmax]
Plasma concentration of HMPL004-6599 to evaluate protocol specified Pharmacokinetic parameters. Where these PK parameters are derived from plasma concentrations of AND, DDAND, HM5013620, DAND and NAND and include but are not limited to the Cmax determination after single (Part A) and multiple (Part B) oral doses in healthy male volunteers.
Measured: Part A: single dose; Part B: 21 days
Area Under The Concentration Time Curve Up To The Time 't' [AUC0-t]
Plasma concentration of HMPL004-6599 to evaluate protocol specified Pharmacokinetic parameters. Where these PK parameters are derived from plasma concentrations of AND, DDAND, HM5013620, DAND and NAND and include but are not limited to the AUC0-t determination after single (Part A) and multiple (Part B) oral doses in healthy male volunteers.
Measured: Part A: single dose; Part B: 21 days
Time of Maximum Plasma Drug Concentration [Tmax]
Plasma concentration of HMPL004-6599 to evaluate protocol specified Pharmacokinetic parameters. Where these PK parameters are derived from plasma concentrations of AND, DDAND, HM5013620, DAND and NAND and include but are not limited to the Tmax determination after single (Part A) and multiple (Part B) oral doses in healthy male volunteers.
Measured: Part A: single dose; Part B: 21 days
Area Under The Concentration Time Curve Up To The Last Data Point Above LOQ [AUClast]
Plasma concentration of HMPL004-6599 to evaluate protocol specified Pharmacokinetic parameters. Where these PK parameters are derived from plasma concentrations of AND, DDAND, HM5013620, DAND and NAND and include but are not limited to the AUClast determination after single (Part A) and multiple (Part B) oral doses in healthy male volunteers.
Measured: Part A: single dose; Part B: 21 days
Apparent Half-Life For Designated Elimination Phases [t1/2]
Plasma concentration of HMPL004-6599 to evaluate protocol specified Pharmacokinetic parameters. Where these PK parameters are derived from plasma concentrations of AND, DDAND, HM5013620, DAND and NAND and include but are not limited to the t1/2 determination after single (Part A) and multiple (Part B) oral doses in healthy male volunteers.
Measured: Part A: single dose; Part B: 21 days
Area Under The Concentration-Time Curve During Once Dosing Interval [AUCTau or AUC0-_]
Plasma concentration of HMPL004-6599 to evaluate protocol specified Pharmacokinetic parameters. Where these PK parameters are derived from plasma concentrations of AND, DDAND, HM5013620, DAND and NAND and include but are not limited to the AUCTau or AUC0-_determination after multiple (Part B) oral doses in healthy male volunteers.
Measured: Part B: 21 days
Minimum Observed Concentration [Cmin]
Plasma concentration of HMPL004-6599 to evaluate protocol specified Pharmacokinetic parameters. Where these PK parameters are derived from plasma concentrations of AND, DDAND, HM5013620, DAND and NAND and include but are not limited to the AUCTau or AUC0-_determination after multiple (Part B) oral doses in healthy male volunteers.
Measured: Part B: 21 days
Average Concentration [Cavg]
Plasma concentration of HMPL004-6599 to evaluate protocol specified Pharmacokinetic parameters. Where these PK parameters are derived from plasma concentrations of AND, DDAND, HM5013620, DAND and NAND and include but are not limited to the Cavg determination after multiple (Part B) oral doses in healthy male volunteers.
Measured: Part B: 21 days
%_Fluctuation
Plasma concentration of HMPL004-6599 to evaluate protocol specified Pharmacokinetic parameters. Where these PK parameters are derived from plasma concentrations of AND, DDAND, HM5013620, DAND and NAND and include but are not limited to the %_Fluctuation determination after multiple (Part B) oral doses in healthy male volunteers.
Measured: Part B: 21 days
Accumulation Ratio_obs
Plasma concentration of HMPL004-6599 to evaluate protocol specified Pharmacokinetic parameters. Where these PK parameters are derived from plasma concentrations of AND, DDAND, HM5013620, DAND and NAND and include but are not limited to the Accumulation Ratio_obs determination after multiple (Part B) oral doses in healthy male volunteers.
Measured: Part B: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start20 Mar 2018
- Primary completion19 Nov 2018
- Study completion19 Nov 2018
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- Parallel groups
- Model description
- Double blind, randomized, placebo-controlled, dose-escalating, single dose study in healthy volunteers followed by a double blind, randomized, placebo-controlled, dose-escalating, multiple dose study in healthy volunteers.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutrition Science Partners Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hutchison Medipharma Limited, Société des Produits Nestlé (SPN)
- Responsible party
- Sponsor
- Investigators
- Wu Yan, MD, Study director, Hutchison Medipharma Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597971
- Sponsor's protocol ID
- 2017-599-00AU1
- Status last verified
- Dec 2019
- First submitted
- 3 May 2018
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double Blind, Placebo-controlled, Dose-escalating Study of the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of HMPL004-6599 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03597971
- Acronym / sponsor ID
- 2017-599-00AU1
- Conditions
- Ulcerative Colitis, Crohn Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Nutrition Science Partners LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Hutchison Medipharma Limited, Société des Produits Nestlé (SPN)
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 19 Nov 2018 (actual)
- Study completion
- 19 Nov 2018 (actual)
- First posted
- 24 Jul 2018 (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.
To assess the safety and tolerability of single and multiple doses of HMPL004-6599 in healthy male volunteers
Detailed description
This is a Phase I study with two parts:
Part A: Double blind, randomized, placebo-controlled, dose-escalating, single dose study in healthy volunteers.
Subjects will receive a single dose of up to 1800 mg HMPL004-6599 or matching placebo on Day 1. The planned dose levels are: 600, 1200, and 1800 mg under fed conditions with a standard meal, according to the randomization schedule. Dose levels may be repeated, or reduced if deemed appropriate by the Safety Monitoring Committee (SMC).
Part B: Double blind, randomized, placebo-controlled, dose-escalating, multiple dose study in healthy male volunteers.
Dose levels in Part B for 14 days are planned as 200mg TID, 400mg TID, 600mg BID and 600mg TID. These dose were jointly decided by the PI, SMC and the Sponsor based on the results from Part A. On day 14, only one dose in the morning will be administrated for all cohorts. Dose levels may be repeated, or reduced if deemed appropriate by the Safety Monitoring Committee (SMC).
In Part A, cohort 1 will consist of a blinded sentinel group of two subjects; one subject will receive HMPL004-6599 and the other will receive placebo, at least 24 hours prior to dosing the remaining 6 subjects in the cohort. The remaining subjects will only be dosed after review of available safety data from the sentinel subjects.
During Part A and Part B, PK sample collections will take place. During Part A, a full PK profile will be measured throughout Day 1. Samples will be collected from pre-dose to 24 hours post dose.
Part B PK sample collection is based on Part A study data. A full PK testing of plasma samples from pre-dose to 8 (TID) or 12 (BID) hours post dose will be collected on the first and last dosing days. Stool samples produced at baseline before dose and day 14-15 post last dose will be collected.
Concentrations of Andrographolide (AND), 14-deoxy-11,12- didehydroandrographolide (DDAND), HM5013620, neoandrographolide (NAND) and 14-deoxyandrographolide (DAND) in plasma (Part A and B) and fecal samples (Part B) will be determined for each dose level.
The plasma samples will be analyzed at the lab contracted by the Sponsor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double blind, randomized, placebo-controlled, dose-escalating, single dose study in healthy volunteers followed by a double blind, randomized, placebo-controlled, dose-escalating, multiple dose study in healthy volunteers.
| Arm | Type | Receives |
|---|---|---|
| Part A: experimental | Experimental | Drug: HMPL004-6599Subjects will receive HMPL004-6599 or matching placebo on Day 1. This will be administered under fed conditions with a standard meal, according to the randomization schedule. Dose levels may be repeated, or reduced if deemed appropriate by the Safety Monitoring Committee (SMC). |
| Part A: placebo | Placebo comparator | Drug: PlaceboSubjects will receive matching placebo on Day 1. This will be administered under fed conditions with a standard meal, according to the randomization schedule. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Informed consent must be obtained in writing for all subjects before enrollment into the study.
- Healthy male subjects aged 18 to 45 years inclusive at the time of screening.
- Body mass index ≥19.0 and ≤ 30.0 kg/m2
- No clinically significant abnormalities as determined by medical history and physical examination, especially with regard to the liver, bile and gastrointestinal systems.
- No clinically significant laboratory values and urinalysis, as determined by the Clinical Investigator.
Key exclusion criteria (29 listed)
- Family history of premature Coronary Heart Disease
- History of immunosuppression or opportunistic infections or receipt of a live virus vaccination within the 3 months prior to screening.
- Subjects at risk for tuberculosis (TB), specifically subjects with:
- History of hypertension requiring treatment.
- Any condition requiring the regular use of any medication.
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 |
|---|---|---|
| HMPL004-6599For each cohort, 6 subjects will receive HMPL004-6599 | Drug | Part A: experimental |
| PlaceboFor each cohort, 2 subjects will receive placebo | Drug | Part A: placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Part A: single dose; Part B: 21 days
A primary objective of this study is to assess the safety of a single dose of up to 1800 mg in Part A (evaluated in planned steps of 600, 1200, and 1800 mg HMPL004-6599 under fed conditions of a standard meal), followed by multiple doses of up to 1800mg in Part B (evaluated in planned steps of 200mg TID, 400mg TID, 600mg BID and 600mg TID HMPL004-599 under fed conditions of a standard meal for 14 days ) in healthy male volunteers. The occurrence of Serious Adverse Events and Adverse Events will be evaluated during the study in order to determine this primary objective.
Incidence of Participants with Abnormal Laboratory Values
Time frame: Part A: single dose; Part B: 21 days
A further primary objective of this study is to assess the tolerability of a single dose of up to 1800 mg in Part A (evaluated in planned steps of 600, 1200, and 1800 mg HMPL004-6599 under fed conditions of a standard meal), followed by multiple doses of up to 1800mg in Part B (evaluated in planned steps of 200mg TID, 400mg TID, 600mg BID and 600mg TID HMPL004-599 under fed conditions of a standard meal for 14 days ) in healthy male volunteers. The occurrence of abnormal laboratory values will be reviewed during the study in order to determine this primary objective.
10 secondary outcomes
Maximum Plasma Concentration [Cmax]
Time frame: Part A: single dose; Part B: 21 days
Area Under The Concentration Time Curve Up To The Time 't' [AUC0-t]
Time frame: Part A: single dose; Part B: 21 days
Time of Maximum Plasma Drug Concentration [Tmax]
Time frame: Part A: single dose; Part B: 21 days
Area Under The Concentration Time Curve Up To The Last Data Point Above LOQ [AUClast]
Time frame: Part A: single dose; Part B: 21 days
Apparent Half-Life For Designated Elimination Phases [t1/2]
Time frame: Part A: single dose; Part B: 21 days
Area Under The Concentration-Time Curve During Once Dosing Interval [AUCTau or AUC0-_]
Time frame: Part B: 21 days
Minimum Observed Concentration [Cmin]
Time frame: Part B: 21 days
Average Concentration [Cavg]
Time frame: Part B: 21 days
%_Fluctuation
Time frame: Part B: 21 days
Accumulation Ratio_obs
Time frame: Part B: 21 days
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
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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.
Wu Yan, MD study director
Hutchison Medipharma Limited
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 HMPL004-6599 in people with Ulcerative Colitis and Crohn Disease, run by Nutrition Science Partners Limited at 1 site in Australia.
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 8 inclusion and 29 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: stopped early, as of the sponsor's last update on 17 Dec 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 Australia. 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 was stopped early (reason given: Sponsor decision). Results are not available in the source record.
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?
Incidence of Treatment-Emergent Adverse Events (time frame: Part A: single dose; Part B: 21 days). The study lists 2 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 Dec 2019.