HealthyPhase 1NCT03977974

A Study of LY3526318 in Healthy Participants

A Phase 1 study testing LY3526318 in people with Healthy, run by Eli Lilly and Company at 1 site in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The main purpose of this study is to learn more about the safety and side effects of LY3526318 when given by mouth to healthy participants. The study will have two parts. Each participant will enroll in only one part. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: LY3526318
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 76 participants
Where: 1 siteNetherlands
Study dates: 21 Jun 2019to 5 Mar 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 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Part A Cohorts:
Healthy male participants (including self-reported surgically sterile males) must agree to the following:
When engaging in sex with Women of Child-Bearing Potential (WOCBP) both the male participant and his female partner must use highly effective contraception consisting of 2 forms of birth control (1 of which must be a male barrier method such as a latex or polyurethane condom) from start of dosing throughout the clinical study period, and for 90 days after the final study drug administration
Nonsurgically sterile male participants must not donate sperm at any time from start of dosing until 90 days beyond the administration of study drug
All Part A and Part B Cohorts:
Female participants must be nonpregnant and not lactating, or of nonchildbearing potential (either surgically sterilized [e.g. tubal occlusion, hysterectomy, bilateral salpingectomy] or physiologically incapable of becoming pregnant, or postmenopausal with amenorrhea for at least 12 consecutive months). Healthy female participants of child-bearing potential who have a fertile male sexual partner must be willing and able to practice effective contraception from admission to 30 days after the final visit. Sexually active participants must use a combination of 2 of the following methods of contraception, including at least 1 so-called 'barrier' method:

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Hormonal contraceptive (oral, transdermal patches, vaginal or injectable)
Intrauterine device with or without hormones
Condom ('barrier' method)
Diaphragm or cervical cap
Sexual abstinence
Have a body mass index 18 to 32 kilograms per square meter (kg/m²)

Who cannot join

Are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, convulsions, or any clinically significant laboratory abnormality
In the opinion of the investigator are considered to be a danger to themselves
Have an abnormality in the 12-lead electrocardiogram (ECG)
Have a history of clinically significant multiple or severe drug allergies or severe post treatment hypersensitivity reactions
Have donated blood of more than 500 milliliter (mL) within the previous month

Show all 12Show fewer

Are unwilling to stop alcohol and caffeinated beverage consumption and smoking/use of tobacco while resident in the CRU
Have an average weekly alcohol intake that exceeds 21 units per week (1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits
Have an abnormal blood pressure
Participants with a history of drug abuse
Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer)
Are unwilling to comply with the required dietary restrictions

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

PRA Health Sciences
Groningen, 9728

Other trials in Netherlands

About this study

Official title: A Safety, Tolerability, Pharmacokinetic, and Pilot Food Effect Study of Single- and Multiple-Ascending Doses of LY3526318 in Healthy Participants

Conditions: Healthy
Being tested: LY3526318, Placebo

What participants receive

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

LY3526318Drug
Administered orally
PlaceboDrug
Administered orally

Study groups in NCT03977974
Study group	Role	What they receive
LY3526318 - Part A	Experimental	Single-ascending dose (SAD) 10 milligram (mg), 30 mg, 50 mg, or 300 mg LY3526318 administered orally. 100 mg LY3526318 administered orally without a meal in period 1 and 30 mg LY3526318 administered orally with a meal in period 2. 200 mg LY3526318 administered orally without a meal in period 1 and 200 mg LY3526318 administered orally with a meal in period 2. 100 mg LY3526318 Fed: Period 1: 100 mg LY3526318 administered orally 30 minutes (min) after breakfast (Fed (-30 min.)). Period 2: 100 mg LY3526318 orally 30 minutes before breakfast (Fed (+30 min.)). Period 3: 100 mg LY3526318 administered orally 60 minutes before breakfast (Fed (+60 min.)). Placebo Fed: Period 1: Placebo administered orally 30 minutes after breakfast (Fed (-30 min.)). Period 2: Placebo administered orally 30 minutes before breakfast (Fed (+30 min.)). Period 3: Placebo administered orally 60 minutes before breakfast (Fed (+60 min.)). Receives: Drug: LY3526318
Placebo - Part A	Placebo comparator	Participants received placebo administered orally once. Receives: Drug: Placebo
LY3526318 - Part B	Experimental	Multiple-ascending dose (MAD): 30 mg LY3526318 once daily (QD): Participants received 30 mg LY3526318 QD administered orally for 14 days. MAD: 60 mg LY3526318 QD: Participants received 60 mg LY3526318 QD administered orally for 14 days. MAD: 100 mg LY352631 QD: Participants received 100 mg LY3526318 QD administered orally for 14 days. Receives: Drug: LY3526318
Placebo - Part B	Placebo comparator	Participants received placebo QD orally for 14 days. Receives: Drug: Placebo

What is being measured

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

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
An SAE is any AE from this study that results in 1 of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e. immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect and important medical events that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent 1 of the other outcomes listed in the definition. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, are reported in the Adverse Events module section.
Measured: Baseline Up To 32 Days

Secondary outcomes (6)

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3526318
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3526318
Measured: SAD: Day 1: predose, 1, 2, 4, 6, 8 and 12 hours postdose; Day 2 and Day 3: 24 and 48 hours postdose; 3-Period Food Effect Arms: Day 1: Predose, 1, 2, 4, 6, 8 and 12 hours, Day 2, Day 3 and Day 4: Predose, 24, 48 and 72 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 24 Hours (AUC[0-24]) of LY3526318
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 24 hours (AUC[0-24]) of LY3526318
Measured: MAD: Day 1: Predose,1, 2, 4, 6, 8 and 12 hours post dose
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
Measured: SAD: Day 1: predose, 1, 2, 4, 6, 8 and 12 hours postdose; Day 2 and Day 3: 24 and 48 hours postdose; 3-Period Food Effect Arms: Day 1: Predose, 1, 2, 4, 6, 8 and 12 hours, Day 2, Day 3 and Day 4: Predose, 24, 48 and 72 hours postdose
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
Measured: MAD: Day 1 and Day 14: Predose, 1, 2, 4, 6, 8 and 12 hours post dose
PK: Time to Maximum Concentration (Tmax) of LY3526318
PK: Time to Maximum Concentration (Tmax) of LY3526318
Measured: SAD: Day 1: predose, 1, 2, 4, 6, 8 and 12 hours postdose; Day 2 and Day 3: 24 and 48 hours postdose; 3-Period Food Effect Arms: Day 1: Predose, 1, 2, 4, 6, 8 and 12 hours, Day 2, Day 3 and Day 4: Predose, 24, 48 and 72 hours postdose
PK: Time to Maximum Concentration (Tmax) of LY3526318
PK: Time to Maximum Concentration (Tmax) of LY3526318
Measured: MAD: Day 1 and Day 14: Predose, 1, 2, 4, 6, 8 and 12 hours post dose

Timeline

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

21 Jun 20195 Mar 2020

First posted6 Jun 2019
Study start21 Jun 2019
Primary completion5 Mar 2020
Study completion5 Mar 2020

Why it stopped: COVID-19 pandemic.

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 HealthyStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe 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: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03977974
Sponsor's protocol ID: 17426
Other IDs: J2D-MC-CVAA, 2019-001902-80, 2019
Status last verified: Sep 2025
First submitted: 5 Jun 2019
Last updated: 12 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Safety, Tolerability, Pharmacokinetic, and Pilot Food Effect Study of Single- and Multiple-Ascending Doses of LY3526318 in Healthy Participants
ClinicalTrials.gov ID: NCT03977974
Acronym / sponsor ID: 17426
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: COVID-19 pandemic.
Enrolment: 76 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 21 Jun 2019 (actual)
Primary completion: 5 Mar 2020 (actual)
Study completion: 5 Mar 2020 (actual)
First posted: 6 Jun 2019 (actual)
Results: Posted 12 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
LY3526318 - Part A	Experimental	Drug: LY3526318Single-ascending dose (SAD) 10 milligram (mg), 30 mg, 50 mg, or 300 mg LY3526318 administered orally. 100 mg LY3526318 administered orally without a meal in period 1 and 30 mg LY3526318 administered orally with a meal in period 2. 200 mg LY3526318 administered orally without a meal in period 1 and 200 mg LY3526318 administered orally with a meal in period 2. 100 mg LY3526318 Fed: Period 1: 100 mg LY3526318 administered orally 30 minutes (min) after breakfast (Fed (-30 min.)). Period 2: 100 mg LY3526318 orally 30 minutes before breakfast (Fed (+30 min.)). Period 3: 100 mg LY3526318 administered orally 60 minutes before breakfast (Fed (+60 min.)). Placebo Fed: Period 1: Placebo administered orally 30 minutes after breakfast (Fed (-30 min.)). Period 2: Placebo administered orally 30 minutes before breakfast (Fed (+30 min.)). Period 3: Placebo administered orally 60 minutes before breakfast (Fed (+60 min.)).
Placebo - Part A	Placebo comparator	Drug: PlaceboParticipants received placebo administered orally once.
LY3526318 - Part B	Experimental	Drug: LY3526318Multiple-ascending dose (MAD): 30 mg LY3526318 once daily (QD): Participants received 30 mg LY3526318 QD administered orally for 14 days. MAD: 60 mg LY3526318 QD: Participants received 60 mg LY3526318 QD administered orally for 14 days. MAD: 100 mg LY352631 QD: Participants received 100 mg LY3526318 QD administered orally for 14 days.
Placebo - Part B	Placebo comparator	Drug: PlaceboParticipants received placebo QD orally for 14 days.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Healthy male participants (including self-reported surgically sterile males) must agree to the following:
When engaging in sex with Women of Child-Bearing Potential (WOCBP) both the male participant and his female partner must use highly effective contraception consisting of 2 forms of birth control (1 of which must be a male barrier method such as a latex or polyurethane condom) from start of dosing throughout the clinical study period, and for 90 days after the final study drug administration
Nonsurgically sterile male participants must not donate sperm at any time from start of dosing until 90 days beyond the administration of study drug
Female participants must be nonpregnant and not lactating, or of nonchildbearing potential (either surgically sterilized [e.g. tubal occlusion, hysterectomy, bilateral salpingectomy] or physiologically incapable of becoming pregnant, or postmenopausal with amenorrhea for at least 12 consecutive months). Healthy female participants of child-bearing potential who have a fertile male sexual partner must be willing and able to practice effective contraception from admission to 30 days after the final visit. Sexually active participants must use a combination of 2 of the following methods of contraception, including at least 1 so-called 'barrier' method:
Have a body mass index 18 to 32 kilograms per square meter (kg/m²)

Key exclusion criteria (12 listed)

Are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, convulsions, or any clinically significant laboratory abnormality
In the opinion of the investigator are considered to be a danger to themselves
Have an abnormality in the 12-lead electrocardiogram (ECG)
Have a history of clinically significant multiple or severe drug allergies or severe post treatment hypersensitivity reactions

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
LY3526318Administered orally	Drug	LY3526318 - Part A, LY3526318 - Part B
PlaceboAdministered orally	Drug	Placebo - Part A, Placebo - Part B

Primary outcome

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline Up To 32 Days
An SAE is any AE from this study that results in 1 of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e. immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect and important medical events that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent 1 of the other outcomes listed in the definition. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, are reported in the Adverse Events module section.

6 secondary outcomes

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3526318
Time frame: SAD: Day 1: predose, 1, 2, 4, 6, 8 and 12 hours postdose; Day 2 and Day 3: 24 and 48 hours postdose; 3-Period Food Effect Arms: Day 1: Predose, 1, 2, 4, 6, 8 and 12 hours, Day 2, Day 3 and Day 4: Predose, 24, 48 and 72 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 24 Hours (AUC[0-24]) of LY3526318
Time frame: MAD: Day 1: Predose,1, 2, 4, 6, 8 and 12 hours post dose
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
Time frame: SAD: Day 1: predose, 1, 2, 4, 6, 8 and 12 hours postdose; Day 2 and Day 3: 24 and 48 hours postdose; 3-Period Food Effect Arms: Day 1: Predose, 1, 2, 4, 6, 8 and 12 hours, Day 2, Day 3 and Day 4: Predose, 24, 48 and 72 hours postdose
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
Time frame: MAD: Day 1 and Day 14: Predose, 1, 2, 4, 6, 8 and 12 hours post dose
PK: Time to Maximum Concentration (Tmax) of LY3526318
Time frame: SAD: Day 1: predose, 1, 2, 4, 6, 8 and 12 hours postdose; Day 2 and Day 3: 24 and 48 hours postdose; 3-Period Food Effect Arms: Day 1: Predose, 1, 2, 4, 6, 8 and 12 hours, Day 2, Day 3 and Day 4: Predose, 24, 48 and 72 hours postdose
PK: Time to Maximum Concentration (Tmax) of LY3526318
Time frame: MAD: Day 1 and Day 14: Predose, 1, 2, 4, 6, 8 and 12 hours post dose

Results and safety

Results posted to the registry on 12 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SAD: Placebo	12	12
SAD: 10 mg LY3526318	6	6
SAD: 30 mg LY3526318	6	6
SAD: 50 mg LY3526318	6	6
SAD: 100 mg LY3526318 (Fasted) and 30 mg LY3526318 (Fed)	6	6
SAD: 200 mg LY3526318 (Fasted) and 200 mg LY3526318 (Fed)	6	6
SAD: 300 mg LY3526318	6	6
SAD: 100 mg LY3526318 Fed	3	3
SAD: Placebo Fed	1	1
MAD: Placebo QD	6	6
MAD: 30 mg LY3526318 QD	6	6
MAD: 60 mg LY3526318 QD	6	6
MAD: 100 mg LY352631 QD	6	6

Primary outcome: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame: Baseline Up To 32 Days. Count of participants. Unit: Participants

Measure	SAD: Placebo n = 12	SAD: 10 mg LY3526318 n = 6	SAD: 30 mg LY3526318 n = 6	SAD: 50 mg LY3526318 n = 6	SAD: 100 mg LY3526318 (Fasted) and 30 mg LY3526318 (Fed) n = 6	SAD: 200 mg LY3526318 (Fasted) and 200 mg LY3526318 (Fed) n = 6	SAD: 300 mg LY3526318 n = 6	SAD: 100 mg LY3526318 Fed n = 3	SAD: Placebo Fed n = 1	MAD: Placebo QD n = 6	MAD: 30 mg LY3526318 QD n = 6	MAD: 60 mg LY3526318 QD n = 6	MAD: 100 mg LY352631 QD n = 6
Value	0	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: All participants who received at least one dose of study drug.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline Up To 32 Days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SAD: Placebo	0 of 12 (0%)	3 of 12 (25%)	0 of 12
SAD: 10 mg LY3526318	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
SAD: 30 mg LY3526318	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
SAD: 50 mg LY3526318	0 of 6 (0%)	0 of 6 (0%)	0 of 6
SAD: 100 mg LY3526318	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
SAD: 200 mg LY3526318	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
SAD: 300 mg LY3526318	0 of 6 (0%)	3 of 6 (50%)	0 of 6
SAD: Placebo Fed	0 of 4 (0%)	1 of 4 (25%)	0 of 4
SAD: 30 mg LY3526318 Fed	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
SAD: 200 mg LY3526318 Fed	0 of 6 (0%)	0 of 6 (0%)	0 of 6
SAD: 100 mg LY Fed (-30 Min)	0 of 3 (0%)	3 of 3 (100%)	0 of 3
SAD: 100 mg LY Fed (+30 Min)	0 of 3 (0%)	3 of 3 (100%)	0 of 3
SAD:100 mg LY Fed (+60 Min)	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
SAD: Placebo Fed (-30 Min)	0 of 1 (0%)	1 of 1 (100%)	0 of 1
SAD: Placebo Fed (+30 Min)	0 of 1 (0%)	1 of 1 (100%)	0 of 1
SAD: Placebo Fed (+60 Min)	0 of 1 (0%)	1 of 1 (100%)	0 of 1
MAD: Placebo QD	0 of 6 (0%)	6 of 6 (100%)	0 of 6
MAD: 30 mg LY3526318 QD LY3526318 QD	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
MAD: 60 mg LY3526318 QD LY3526318 QD	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
MAD: 100 mg LY352631 QD	0 of 6 (0%)	6 of 6 (100%)

Limitations and caveats (from the sponsor): Study was terminated due to COVID-19 pandemic.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

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 LY3526318 in people with Healthy, run by Eli Lilly and Company at 1 site in Netherlands.

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 12 inclusion and 12 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 12 Sep 2025. 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 Netherlands. 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 12 Sep 2025). 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 With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline Up To 32 Days). 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 NCT03977974.

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 12 Sep 2025.