Healthy VolunteersPhase 1NCT04503603

A Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered Intravenously in Healthy Adult Volunteer Participants

A Phase 1 study testing Lanadelumab in people with Healthy Volunteers, run by Takeda at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study to evaluate the safety, tolerability and pharmacokinetics (PK) of lanadelumab administered by Intravenous (IV) infusion in healthy adult volunteers. Read more about this study

Who is it for?: Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Lanadelumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 10 Aug 2020to 23 Dec 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 19 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy, adult, male or female, 19-55 years of age, inclusive, at screening.
Continuous non-smoker who has not used nicotine-containing products for at least 30 days prior to the first dosing and throughout the study, based on participant self-reporting.
Body mass index (BMI) greater than or equal to (>=) 18.0 and less than or equal to (<=) 32.0 kilogram per square meter (kg/m^2) at screening.
Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), per the investigator.
Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.
Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol.

Who cannot join

Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
History or presence of clinically significant medical or psychiatric condition or disease per the investigator.
History of any illness that might confound the results of the study or poses an additional risk to the participant by their participation in the study, per the investigator.
History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing per the investigator.
History or presence of hypersensitivity or idiosyncratic reaction to the study drug(s) or related compounds.
History or presence of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gall bladder removal, or current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinically significant clinical or laboratory assessments per the investigator.

Show all 19Show fewer

Female participants with a positive pregnancy test or lactating.
Positive urine drug or alcohol results at screening.
Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
Supine blood pressure is less than 90/40 millimetre of mercury (mmHg) or greater than 140/90 mmHg at screening.
Supine heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at screening.
Orthostatic vital sign results with a decrease in systolic greater than (>) 20 mmHg or decrease in diastolic > 10 mmHg and increase in pulse of > 20 beats per minute.
QTcF interval is > 450 milliseconds (msec) (males) or > 470 msec (females) or ECG findings are deemed abnormal with clinical significance at screening per the investigator.
Estimated creatinine clearance less than (<) 80 milliliters per minute (mL/min) at screening.
Unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing and throughout the study. Medication listed as part of acceptable birth control methods will be allowed. Thyroid hormone replacement medication may be permitted if the participant has been on the same stable dose for the immediate 3 months prior to first study drug administration. After randomization/dosing, a nonsteroidal anti-inflammatory drug may be administered at the discretion of the investigator. Hormone replacement therapy will also be allowed if the participant has been on the same stable dose for the immediate 3 months prior to first study drug administration.
Has been on a diet incompatible with the on-study diet, per the investigator, within the 30 days prior to the first dosing and throughout the study.
Donation of blood or significant blood loss within 56 days prior to the first dosing.
Plasma donation within 7 days prior to the first dosing.
Participation in another clinical study within 30 days or 5 half-lives prior to the first dosing. The 30-day window or 5 half-lives will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study

Trial locations and contacts

1 site in 1 country.

United States1 site

Celerion
Lincoln, Nebraska, 68502

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-Controlled, Repeat-dose, Single-center Phase 1a Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered Intravenously in Healthy Adult Volunteer Subjects

The purpose of this study to evaluate the safety, tolerability and pharmacokinetics (PK) of lanadelumab administered by Intravenous (IV) infusion in healthy adult volunteers.

Read the detailed description

A Randomized, Double-blind, Placebo-Controlled, Repeat-dose, Single-center Phase 1a Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered Intravenously in Healthy Adult Volunteer Subjects

Conditions: Healthy Volunteers
Being tested: Lanadelumab, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LanadelumabDrug
Also called TAK-743
Participants will receive lanadelumab 300 mg IV infusion on Day 1 followed by Day 4.
PlaceboOther
Participants will receive placebo matching to lanadelumab IV infusion on Day 1 followed by Day 4.

Study groups in NCT04503603
Study group	Role	What they receive
Lanadelumab 300 mg	Experimental	Participants will receive single dose of lanadelumab 300 mg intravenous (IV) infusion on Day 1 followed by second dose on Day 4. Receives: Drug: Lanadelumab
Placebo	Placebo comparator	Participant will receive single dose of lanadelumab matching placebo (normal saline) IV infusion on Day 1 followed by second dose on Day 4. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study that did not necessarily have a causal relationship with the treatment. TEAEs were events that occurred on or after the date and time of administration of the first dose of study medication. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs were reported.
Measured: From the first dose of study treatment up to the end of study (Day 112)
Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters
Clinical laboratory assessment included hematology, clinical chemistry, coagulation, and urinalysis. Any changes in clinical laboratory results that were deemed clinically significant were judged by the investigator. The number of participants with clinically significant change from baseline in laboratory values were reported.
Measured: From the first dose of study treatment up to the end of study (Day 112)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Vital signs included blood pressure (systolic and diastolic), heart rate, and body temperature (oral). Any changes in vital signs that were deemed clinically significant were judged by the investigator. The number of participants with clinically significant change from baseline in vital signs were reported.
Measured: From the first dose of study treatment up to the end of study (Day 112)
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings
12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. Any changes in ECG parameters that were deemed clinically significant were judged by the investigator. The number of participants with clinically significant changes from baseline in 12-lead ECG findings were reported.
Measured: From the first dose of study treatment up to the end of study (Day 112)
AUC0-last: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration for Lanadelumab
AUC0-last for lanadelumab was reported.
Measured: Pre-dose (Day 1) up to 2664 hours post-dose
AUC0-inf: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity for Lanadelumab
AUC0-inf for lanadelumab was reported.
Measured: Pre-dose (Day 1) up to 2664 hours post-dose
Cmax1: Maximum Observed Plasma Concentration Following the First IV Dose for Lanadelumab
Cmax1 following the first IV dose for lanadelumab was reported.
Measured: Pre-dose (Day 1) up to 2664 hours post-dose
Cmax2: Maximum Observed Plasma Concentration Following the Second IV Dose for Lanadelumab
Cmax2 following the second IV dose for lanadelumab was reported.
Measured: Pre-dose (Day 4) up to 2592 hours post-dose
Tmax1: Minimum Observed Time to Reach the First Cmax1 for Lanadelumab
Tmax1 following the first IV dose for lanadelumab was reported.
Measured: Pre-dose (Day 1) up to 2664 hours post-dose
Tmax2: Minimum Observed Time to Reach the Second Cmax2 for Lanadelumab
Tmax2 following the second IV dose for lanadelumab was reported.
Measured: Pre-dose (Day 4) up to 2592 hours post-dose
Terminal Half-Life (T1/2) of Lanadelumab in Plasma
T1/2 is defined as the time required for the concentration of the drug to reach half of its original value. T1/2 for lanadelumab was reported.
Measured: Pre-dose (Day 1) up to 2664 hours post-dose
Clearance (CL) of Lanadelumab in Plasma
Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body. CL for lanadelumab was reported.
Measured: Pre-dose (Day 1) up to 2664 hours post-dose
Vss: Volume of Distribution at Steady State in Plasma for Lanadelumab
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss for lanadelumab was reported.
Measured: Pre-dose (Day 1) up to 2664 hours post-dose
First Order Elimination Rate Constant Associated With the Terminal (Log-linear) Portion of the Curve (Lambda z) of Lanadelumab
Lambda z of Lanadelumab was reported.
Measured: Pre-dose (Day 1) up to 2664 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Aug 202023 Dec 2020

First posted7 Aug 2020
Study start10 Aug 2020
Primary completion23 Dec 2020
Study completion23 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by TakedaThe 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
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04503603
Sponsor's protocol ID: TAK-743-1003
Status last verified: Dec 2021
First submitted: 5 Aug 2020
Last updated: 7 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-Controlled, Repeat-dose, Single-center Phase 1a Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered Intravenously in Healthy Adult Volunteer Subjects
ClinicalTrials.gov ID: NCT04503603
Acronym / sponsor ID: TAK-743-1003
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Collaborators: Takeda Development Center Americas, Inc.
Study start: 10 Aug 2020 (actual)
Primary completion: 23 Dec 2020 (actual)
Study completion: 23 Dec 2020 (actual)
First posted: 7 Aug 2020 (actual)
Results: Posted 7 Mar 2022

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 this study to evaluate the safety, tolerability and pharmacokinetics (PK) of lanadelumab administered by Intravenous (IV) infusion in healthy adult volunteers.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Lanadelumab 300 mg	Experimental	Drug: LanadelumabParticipants will receive single dose of lanadelumab 300 mg intravenous (IV) infusion on Day 1 followed by second dose on Day 4.
Placebo	Placebo comparator	Other: PlaceboParticipant will receive single dose of lanadelumab matching placebo (normal saline) IV infusion on Day 1 followed by second dose on Day 4.

Who may qualify

Ages: 19 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Healthy, adult, male or female, 19-55 years of age, inclusive, at screening.
Continuous non-smoker who has not used nicotine-containing products for at least 30 days prior to the first dosing and throughout the study, based on participant self-reporting.
Body mass index (BMI) greater than or equal to (>=) 18.0 and less than or equal to (<=) 32.0 kilogram per square meter (kg/m^2) at screening.
Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), per the investigator.
Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.

Key exclusion criteria (19 listed)

Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
History or presence of clinically significant medical or psychiatric condition or disease per the investigator.
History of any illness that might confound the results of the study or poses an additional risk to the participant by their participation in the study, per the investigator.
History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing per the investigator.
History or presence of hypersensitivity or idiosyncratic reaction to the study drug(s) or related compounds.

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
LanadelumabAlso: TAK-743Participants will receive lanadelumab 300 mg IV infusion on Day 1 followed by Day 4.	Drug	Lanadelumab 300 mg
PlaceboParticipants will receive placebo matching to lanadelumab IV infusion on Day 1 followed by Day 4.	Other	Placebo

Primary outcome

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Time frame: From the first dose of study treatment up to the end of study (Day 112)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study that did not necessarily have a causal relationship with the treatment. TEAEs were events that occurred on or after the date and time of administration of the first dose of study medication. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs were reported.
Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters
Time frame: From the first dose of study treatment up to the end of study (Day 112)
Clinical laboratory assessment included hematology, clinical chemistry, coagulation, and urinalysis. Any changes in clinical laboratory results that were deemed clinically significant were judged by the investigator. The number of participants with clinically significant change from baseline in laboratory values were reported.
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: From the first dose of study treatment up to the end of study (Day 112)
Vital signs included blood pressure (systolic and diastolic), heart rate, and body temperature (oral). Any changes in vital signs that were deemed clinically significant were judged by the investigator. The number of participants with clinically significant change from baseline in vital signs were reported.
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings
Time frame: From the first dose of study treatment up to the end of study (Day 112)
12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. Any changes in ECG parameters that were deemed clinically significant were judged by the investigator. The number of participants with clinically significant changes from baseline in 12-lead ECG findings were reported.
AUC0-last: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration for Lanadelumab
Time frame: Pre-dose (Day 1) up to 2664 hours post-dose
AUC0-last for lanadelumab was reported.
AUC0-inf: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity for Lanadelumab
Time frame: Pre-dose (Day 1) up to 2664 hours post-dose
AUC0-inf for lanadelumab was reported.
Cmax1: Maximum Observed Plasma Concentration Following the First IV Dose for Lanadelumab
Time frame: Pre-dose (Day 1) up to 2664 hours post-dose
Cmax1 following the first IV dose for lanadelumab was reported.
Cmax2: Maximum Observed Plasma Concentration Following the Second IV Dose for Lanadelumab
Time frame: Pre-dose (Day 4) up to 2592 hours post-dose
Cmax2 following the second IV dose for lanadelumab was reported.
Tmax1: Minimum Observed Time to Reach the First Cmax1 for Lanadelumab
Time frame: Pre-dose (Day 1) up to 2664 hours post-dose
Tmax1 following the first IV dose for lanadelumab was reported.
Tmax2: Minimum Observed Time to Reach the Second Cmax2 for Lanadelumab
Time frame: Pre-dose (Day 4) up to 2592 hours post-dose
Tmax2 following the second IV dose for lanadelumab was reported.
Terminal Half-Life (T1/2) of Lanadelumab in Plasma
Time frame: Pre-dose (Day 1) up to 2664 hours post-dose
T1/2 is defined as the time required for the concentration of the drug to reach half of its original value. T1/2 for lanadelumab was reported.
Clearance (CL) of Lanadelumab in Plasma
Time frame: Pre-dose (Day 1) up to 2664 hours post-dose
Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body. CL for lanadelumab was reported.
Vss: Volume of Distribution at Steady State in Plasma for Lanadelumab
Time frame: Pre-dose (Day 1) up to 2664 hours post-dose
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss for lanadelumab was reported.
First Order Elimination Rate Constant Associated With the Terminal (Log-linear) Portion of the Curve (Lambda z) of Lanadelumab
Time frame: Pre-dose (Day 1) up to 2664 hours post-dose
Lambda z of Lanadelumab was reported.

Results and safety

Results posted to the registry on 7 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lanadelumab 300 mg	9	9
Placebo	3	3

Primary outcome: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)

Time frame: From the first dose of study treatment up to the end of study (Day 112). Count of participants. Unit: Participants

Measure	Lanadelumab 300 mg n = 9	Placebo n = 3
Value	7	2

Population analysed: The safety analysis set consisted of all participants who had started at least 1 dose of lanadelumab or placebo.

Primary outcome: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters

Time frame: From the first dose of study treatment up to the end of study (Day 112). Count of participants. Unit: Participants

Measure	Lanadelumab 300 mg n = 9	Placebo n = 3
Value	0	0

Population analysed: The safety analysis set consisted of all participants who had started at least 1 dose of lanadelumab or placebo.

Primary outcome: Number of Participants With Clinically Significant Change From Baseline in Vital Signs

Time frame: From the first dose of study treatment up to the end of study (Day 112). Count of participants. Unit: Participants

Measure	Lanadelumab 300 mg n = 9	Placebo n = 3
Value	0	0

Population analysed: The safety analysis set consisted of all participants who had started at least 1 dose of lanadelumab or placebo.

Primary outcome: Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings

Time frame: From the first dose of study treatment up to the end of study (Day 112). Count of participants. Unit: Participants

Measure	Lanadelumab 300 mg n = 9	Placebo n = 3
Value	0	0

Population analysed: The safety analysis set consisted of all participants who had started at least 1 dose of lanadelumab or placebo.

Adverse events

Time frame: From the first dose of study treatment up to the end of study (Day 112). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lanadelumab 300 mg	0 of 9 (0%)	7 of 9 (77.8%)	0 of 9
Placebo	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain more information on the study, click here/on this linkLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

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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

Takeda Development Center Americas, Inc.

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 Lanadelumab in people with Healthy Volunteers, run by Takeda 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 6 inclusion and 19 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 7 Mar 2022. 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?

Yes. Results are posted in the registry (first posted 7 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) (time frame: From the first dose of study treatment up to the end of study (Day 112)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04503603.

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 7 Mar 2022.