HealthyPhase 1NCT05070702

First in Human Study of CT-1500 in Healthy Participants

A Phase 1 study testing CT-1500 in people with Healthy, run by Circadian Therapeutics Ltd at 1 site in Australia.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: CT-1500
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 1 siteAustralia
Study dates: 8 Nov 2021to 7 Jul 2022
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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Generally healthy with the exception of those medical conditions allowed per the study criteria
Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol, prior to any study procedures
Body Mass Index (BMI) of 18.5 to 32 kg/m2 and weight >48 kg
Systolic Blood Pressure (BP) of 90-140 mmHg, Diastolic BP of 40-90 mmHg and Heart Rate between 40 and 100 bpm
Forced Expiratory Volume in one second (FEV1) > 85% predicted
Clinical laboratory results at screening and Day -1 to be within normal limits unless deemed as not clinically significant by the investigator

Show all 10Show fewer

Willing to consume bovine containing products (investigational product capsules are bovine gelatin in origin);
Agree not to donate blood or plasma products for at least 30 days after the end of study (EOS) visit
Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Day -1, must not be breastfeeding, lactating or planning a pregnancy and must use an acceptable form of contraception during the treatment period and for 32 days after the last dose
Male participants with a female partner of childbearing potential must agree to use an acceptable form of contraception during the treatment period and for 92 days after the last dose

Who cannot join

Significant current or historical disease, including intercurrent illness in the 4 weeks prior to screening
Current or historical diagnosis of sleep disorders
Hepatic disorders other than benign unconjugated hyperbilirubinaemia
History of moderate or severe psychiatric illness
History of severe allergy or anaphylaxis to any drug, food, toxin or other exposure
Heavy caffeine drinker in the last 3 months. If subjects are willing to reduce their caffeine intake for 14 days prior to first dose and for the duration of the study, they can participate

Show all 19Show fewer

Hypersensitivity to CT-1500 or any of the inert excipients in the capsule formulation
Positive hepatitis B surface antigen (HBsAg), positive hepatitis C antibody (HCV) or positive human immunodeficiency virus (HIV) test
Treatment with an investigational drug within 30 days or less than 5 half-lives (whichever is longer) prior to screening
Use of prescription medication within 14 days prior to investigational product administration until the end of study visit, with the exception of oral contraceptives.
Use of over-the-counter medication and supplements for 7 days prior to investigation product administration until the end of study visit. Exceptions at the discretion of the investigator.
Receipt of a Coronavirus disease 2019 (COVID-19) vaccine within 14 days prior to investigational product administration or a planned second dose of a COVID-19 vaccine during study participation
Use of tobacco or nicotine-containing products in excess of 2 cigarettes per day within 1 month prior to screening
Major surgery in the 6 months preceeding screening or planned surgery during the study
Donated blood or blood products or had a substantial loss of blood with 3 months prior to screening
A history of drug abuse or addiction
A history of alcoholism or consumption of more than 3 alcoholic drinks per day or consumption of alcohol within 48 hours prior to first dose
Unable to abstain from grapefruit-containing foods or beverages or Seville orange-containing foods or beverages from 48 hours prior to investigational product administration until completion of the confinement period;
Unable to avoid heavy exercise (eg, marathon runners, weight-lifters) from 48 hours prior to investigational product administration until completion of the confinement period

Trial locations and contacts

1 site in 1 country.

Australia1 site

Nucleus Network
Melbourne, Victoria, 3004

Other trials in Australia

About this study

Official title: First in Human Study in Healthy Subjects to Investigate the Safety, Tolerability and Pharmacokinetics of Single Ascending and Repeat Doses of CT-1500

Read the detailed description

This study is a single center, randomized, placebo-controlled, double-blind study of CT-1500 in healthy volunteers. The study will evaluate the safety, tolerability and pharmacokinetics of single ascending doses and multiple ascending doses of orally administered CT-1500 compared to placebo. It is planned for 5 dose levels to be investigated in the single ascending dose (SAD) part (Part 1) of the study, between 5 mg to 120 mg. Three dose levels are proposed for investigation in the multiple ascending dose (MAD) part (Part 2) of the study.

Conditions: Healthy
Being tested: CT-1500, Placebo

What participants receive

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

CT-1500Drug
Hard Capsule
PlaceboDrug
Hard Capsule

Study groups in NCT05070702
Study group	Role	What they receive
CT-1500 Active (SAD)	Experimental	6 out of 8 participants per cohort (up to 5 cohorts) will be randomized to receive a single oral dose of CT-1500 between 5 mg and 120 mg Receives: Drug: CT-1500
Placebo (SAD)	Placebo comparator	2 out of 8 participants per cohort (up to 5 cohorts) will be randomized to receive a single oral dose of matching placebo Receives: Drug: Placebo
CT-1500 Active (MAD)	Experimental	6 out of 8 participants per cohort (up to 3 cohorts) will be randomized to receive 7 daily oral doses of CT-1500 between 5 and 45 mg Receives: Drug: CT-1500
Placebo (MAD)	Placebo comparator	2 out of 8 participants per cohort (up to 3 cohorts) will be randomized to receive 7 daily oral doses of matching placebo Receives: Drug: Placebo

What is being measured

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

Adverse Events (AEs) and Serious Adverse Events (SAEs) during the SAD part of the study
Incidence and severity of AEs and SAEs
Measured: Initiation of dosing through 7 days post dose
Adverse Events and Serious Adverse Events during the MAD part of the study
Incidence and severity of AEs and SAEs
Measured: Initiation of dosing through 14 days post dose
Tolerability of CT-1500 as defined by change from baseline in Heart Rate (SAD)
Measured: Initiation of dosing through 7 days post dose
Tolerability of CT-1500 as defined by change from baseline in Heart Rate (MAD)
Measured: Initiation of dosing through 14 days post dose
Tolerability of CT-1500 as defined by change from baseline in Respiratory Rate (SAD)
Measured: Initiation of dosing through 7 days post dose
Tolerability of CT-1500 as defined by change from baseline in Respiratory Rate (MAD)
Measured: Initiation of dosing through 14 days post dose
Tolerability of CT-1500 as defined by change from baseline in Electrocardiogram Assessment (SAD)
Change in QT interval from baseline
Measured: Initiation of dosing through 7 days post dose
Tolerability of CT-1500 as defined by change from baseline in Electrocardiogram assessment (MAD)
Change in QT interval from baseline
Measured: Initiation of dosing through 14 days post dose
Tolerability of CT-1500 as defined by change from baseline in Spirometry assessment (SAD)
Change from baseline in Forced Expiratory Volume in 1 second (FEV1)
Measured: Initiation of dosing through 7 days post dose
Tolerability of CT-1500 as defined by change from baseline in Spirometry assessment (MAD)
Change from baseline in Forced Expiratory Volume in 1 second (FEV1)
Measured: Initiation of dosing through 14 days post dose
Change in Renal function from baseline (SAD)
Renal Function as assessed by change in estimated Glomerular Filtration Rate from baseline
Measured: Initiation of dosing through 24 hours post dose
Change in Renal function from baseline (MAD)
Renal Function as assessed by change in estimated Glomerular Filtration Rate from baseline
Measured: Initiation of dosing on Day 1 through 24 hours and initiation of dosing on Day 7 through 24 hours

Secondary outcomes (20)

Pharmacokinetic parameter: AUC-last (SAD)
Area under the plasma concentration time curve (AUC) from time zero until the last measurable concentration of CT-1500 is observed during the SAD part of the study
Measured: Baseline (predose) through 48 hours post dose
Pharmacokinetic parameter: AUC-last (SAD)
Area under the plasma concentration time curve from time zero until the last measurable concentration of metabolite CT-1517 is observed during the SAD part of the study
Measured: Baseline (predose) through 48 hours post dose
Pharmacokinetic parameter: AUC-last (SAD)
Area under the plasma concentration time curve from time zero until the last measurable concentration of metabolite CT-1518 is observed during the SAD part of the study
Measured: Baseline (predose) through 48 hours post dose
Pharmacokinetic parameter: AUC-last (MAD)
Area under the plasma concentration time curve from time zero until the last measurable concentration of CT-1500 is observed during the MAD part of the study
Measured: Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Pharmacokinetic parameter: AUC-last (MAD)
Area under the plasma concentration time curve from time zero until the last measurable concentration of metabolite CT-1517 is observed during the MAD part of the study
Measured: Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Pharmacokinetic parameter: AUC-last (MAD)
Area under the plasma concentration time curve from time zero until the last measurable concentration of metabolite CT-1518 is observed during the MAD part of the study
Measured: Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Pharmacokinetic parameter: AUC-inf (SAD)
Area under the plasma concentration time curve from time zero to infinity of CT-1500 is observed during the SAD part of the study
Measured: Baseline (predose) through 48 hours post dose
Pharmacokinetic parameter: AUC-inf (MAD)
Area under the plasma concentration time curve from time zero to infinity of CT-1500 is observed during the MAD part of the study
Measured: Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Pharmacokinetic parameter: Cmax (SAD)
Maximal measured plasma concentration (Cmax) of CT-1500 during the SAD part of the study
Measured: Baseline (predose) through 48 hours post dose
Pharmacokinetic parameter: Cmax (SAD)
Maximal measured plasma concentration of metabolite CT-1517 during the SAD part of the study
Measured: Baseline (predose) through 48 hours post dose
Pharmacokinetic parameter: Cmax (SAD)
Maximal measured plasma concentration of metabolite CT-1518 during the SAD part of the study
Measured: Baseline (predose) through 48 hours post dose
Pharmacokinetic parameter: Cmax (MAD)
Maximal measured plasma concentration of CT-1500 during the MAD part of the study
Measured: Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Pharmacokinetic parameter: Cmax (MAD)
Maximal measured plasma concentration of metabolite CT-1517 during the MAD part of the study
Measured: Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Pharmacokinetic parameter: Cmax (MAD)
Maximal measured plasma concentration of metabolite CT-1518 during the MAD part of the study
Measured: Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Pharmacokinetic parameter: Tmax (SAD)
Time when Maximal measured plasma concentration is observed (Tmax) of CT-1500 during the SAD part of the study
Measured: Baseline (predose) through 48 hours post dose
Pharmacokinetic parameter: Tmax (SAD)
Time when Maximal measured plasma concentration is observed of metabolite CT-1517 during the SAD part of the study
Measured: Baseline (predose) through 48 hours post dose
Pharmacokinetic parameter: Tmax (SAD)
Time when Maximal measured plasma concentration is observed of metabolite CT-1518 during the SAD part of the study
Measured: Baseline (predose) through 48 hours post dose
Pharmacokinetic parameter: Tmax (MAD)
Time when Maximal measured plasma concentration is observed of CT-1500 during the MAD part of the study
Measured: Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Pharmacokinetic parameter: Tmax (MAD)
Time when Maximal measured plasma concentration is observed of metabolite CT-1517 during the MAD part of the study
Measured: Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Pharmacokinetic parameter: Tmax (MAD)
Time when Maximal measured plasma concentration is observed of metabolite CT-1518 during the MAD part of the study
Measured: Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours

Timeline

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

8 Nov 20217 Jul 2022

First posted7 Oct 2021
Study start8 Nov 2021
Primary completion7 Jul 2022
Study completion7 Jul 2022

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: Other
Allocation: Randomised
Intervention model: Sequential
Model description: Ascending Single Doses followed by Ascending Multiple Doses of Study Intervention
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05070702
Sponsor's protocol ID: CT-1500-01
Status last verified: Jul 2022
First submitted: 13 Sep 2021
Last updated: 15 Jul 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The Sponsor will consider requests from appropriately qualified researchers for study information and participant data upon a formal request to contact@circadiantherapeutics.com.

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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Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: First in Human Study in Healthy Subjects to Investigate the Safety, Tolerability and Pharmacokinetics of Single Ascending and Repeat Doses of CT-1500
ClinicalTrials.gov ID: NCT05070702
Acronym / sponsor ID: CT-1500-01
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Circadian Therapeutics LtdIndustry (pharma, biotech, devices)
Collaborators: Neuroscience Trials Australia
Study start: 8 Nov 2021 (actual)
Primary completion: 7 Jul 2022 (actual)
Study completion: 7 Jul 2022 (actual)
First posted: 7 Oct 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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Ascending Single Doses followed by Ascending Multiple Doses of Study Intervention

Arm	Type	Receives
CT-1500 Active (SAD)	Experimental	Drug: CT-15006 out of 8 participants per cohort (up to 5 cohorts) will be randomized to receive a single oral dose of CT-1500 between 5 mg and 120 mg
Placebo (SAD)	Placebo comparator	Drug: Placebo2 out of 8 participants per cohort (up to 5 cohorts) will be randomized to receive a single oral dose of matching placebo
CT-1500 Active (MAD)	Experimental	Drug: CT-15006 out of 8 participants per cohort (up to 3 cohorts) will be randomized to receive 7 daily oral doses of CT-1500 between 5 and 45 mg
Placebo (MAD)	Placebo comparator	Drug: Placebo2 out of 8 participants per cohort (up to 3 cohorts) will be randomized to receive 7 daily oral doses of matching placebo

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Generally healthy with the exception of those medical conditions allowed per the study criteria
Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol, prior to any study procedures
Body Mass Index (BMI) of 18.5 to 32 kg/m2 and weight >48 kg
Systolic Blood Pressure (BP) of 90-140 mmHg, Diastolic BP of 40-90 mmHg and Heart Rate between 40 and 100 bpm
Forced Expiratory Volume in one second (FEV1) > 85% predicted

Key exclusion criteria (19 listed)

Significant current or historical disease, including intercurrent illness in the 4 weeks prior to screening
Current or historical diagnosis of sleep disorders
Hepatic disorders other than benign unconjugated hyperbilirubinaemia
History of moderate or severe psychiatric illness
History of severe allergy or anaphylaxis to any drug, food, toxin or other exposure

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
CT-1500Hard Capsule	Drug	CT-1500 Active (MAD), CT-1500 Active (SAD)
PlaceboHard Capsule	Drug	Placebo (MAD), Placebo (SAD)

Primary outcome

Adverse Events (AEs) and Serious Adverse Events (SAEs) during the SAD part of the study
Time frame: Initiation of dosing through 7 days post dose
Incidence and severity of AEs and SAEs
Adverse Events and Serious Adverse Events during the MAD part of the study
Time frame: Initiation of dosing through 14 days post dose
Incidence and severity of AEs and SAEs
Tolerability of CT-1500 as defined by change from baseline in Heart Rate (SAD)
Time frame: Initiation of dosing through 7 days post dose
Tolerability of CT-1500 as defined by change from baseline in Heart Rate (MAD)
Time frame: Initiation of dosing through 14 days post dose
Tolerability of CT-1500 as defined by change from baseline in Respiratory Rate (SAD)
Time frame: Initiation of dosing through 7 days post dose
Tolerability of CT-1500 as defined by change from baseline in Respiratory Rate (MAD)
Time frame: Initiation of dosing through 14 days post dose
Tolerability of CT-1500 as defined by change from baseline in Electrocardiogram Assessment (SAD)
Time frame: Initiation of dosing through 7 days post dose
Change in QT interval from baseline
Tolerability of CT-1500 as defined by change from baseline in Electrocardiogram assessment (MAD)
Time frame: Initiation of dosing through 14 days post dose
Change in QT interval from baseline
Tolerability of CT-1500 as defined by change from baseline in Spirometry assessment (SAD)
Time frame: Initiation of dosing through 7 days post dose
Change from baseline in Forced Expiratory Volume in 1 second (FEV1)
Tolerability of CT-1500 as defined by change from baseline in Spirometry assessment (MAD)
Time frame: Initiation of dosing through 14 days post dose
Change from baseline in Forced Expiratory Volume in 1 second (FEV1)
Change in Renal function from baseline (SAD)
Time frame: Initiation of dosing through 24 hours post dose
Renal Function as assessed by change in estimated Glomerular Filtration Rate from baseline
Change in Renal function from baseline (MAD)
Time frame: Initiation of dosing on Day 1 through 24 hours and initiation of dosing on Day 7 through 24 hours
Renal Function as assessed by change in estimated Glomerular Filtration Rate from baseline

20 secondary outcomes

Pharmacokinetic parameter: AUC-last (SAD)
Time frame: Baseline (predose) through 48 hours post dose
Pharmacokinetic parameter: AUC-last (SAD)
Time frame: Baseline (predose) through 48 hours post dose
Pharmacokinetic parameter: AUC-last (SAD)
Time frame: Baseline (predose) through 48 hours post dose
Pharmacokinetic parameter: AUC-last (MAD)
Time frame: Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Pharmacokinetic parameter: AUC-last (MAD)
Time frame: Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Pharmacokinetic parameter: AUC-last (MAD)
Time frame: Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Pharmacokinetic parameter: AUC-inf (SAD)
Time frame: Baseline (predose) through 48 hours post dose
Pharmacokinetic parameter: AUC-inf (MAD)
Time frame: Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Pharmacokinetic parameter: Cmax (SAD)
Time frame: Baseline (predose) through 48 hours post dose
Pharmacokinetic parameter: Cmax (SAD)
Time frame: Baseline (predose) through 48 hours post dose
Pharmacokinetic parameter: Cmax (SAD)
Time frame: Baseline (predose) through 48 hours post dose
Pharmacokinetic parameter: Cmax (MAD)
Time frame: Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Pharmacokinetic parameter: Cmax (MAD)
Time frame: Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Pharmacokinetic parameter: Cmax (MAD)
Time frame: Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Pharmacokinetic parameter: Tmax (SAD)
Time frame: Baseline (predose) through 48 hours post dose
Pharmacokinetic parameter: Tmax (SAD)
Time frame: Baseline (predose) through 48 hours post dose
Pharmacokinetic parameter: Tmax (SAD)
Time frame: Baseline (predose) through 48 hours post dose
Pharmacokinetic parameter: Tmax (MAD)
Time frame: Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Pharmacokinetic parameter: Tmax (MAD)
Time frame: Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours
Pharmacokinetic parameter: Tmax (MAD)
Time frame: Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 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 15 Jul 2022.
Individual participant dataSharing planned: Yes. The Sponsor will consider requests from appropriately qualified researchers for study information and participant data upon a formal request to contact@circadiantherapeutics.com.

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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.

Philip Ryan, Dr principal investigator

Nucleus Network

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 CT-1500 in people with Healthy, run by Circadian Therapeutics Ltd 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 10 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 15 Jul 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 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 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?

Adverse Events (AEs) and Serious Adverse Events (SAEs) during the SAD part of the study (time frame: Initiation of dosing through 7 days post dose). The study lists 12 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 NCT05070702.

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 15 Jul 2022.