First in Man Study to Evaluate Initial SafetyPhase 1NCT07809360

Safety, Tolerability and Pharmacokinetics of RNV-166 in Healthy Male Volunteers

A Phase 1 study testing RNV-166_200 mg in people with First in Man Study to Evaluate Initial Safety, run by InVitro Research Solutions Private Limited at 1 site in Bangladesh.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for: First in Man Study to Evaluate Initial Safety
What is being tested?: RNV-166_200 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 66 participants
Where: 1 siteBangladesh
Study dates: 22 Aug 2024to 5 Feb 2025
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 40 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy Male subjects between 18 and 40 years of age (both inclusive).
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECG. A subject with a clinically significant abnormality or laboratory parameters significantly outside the reference range for the population being studied may be included only if according to the investigator's opinion, the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
AST, ALT, alkaline phosphatase and bilirubin ≤1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Non-smoker and non-tobacco user.
No history or current practice of alcohol/substance/drug use.
No history of psychiatric disorders assessed by a clinical psychological evaluation and DSM V criteria.

Show all 13Show fewer

Body mass index (BMI) between 19 and 27 kg/m2 inclusive.
Male subject with female partners of child-bearing potential must agree to use one of the contraception methods. Subjects with female partners of child-bearing potential must use condom while the female partner must use a highly effective contraceptive, such as IUD, birth control pills or diaphragm with spermicide, after the first dose of study treatment and until the end of study visit (for female partners) and during an additional 6 months from the last dose (for subjects themselves).
Has a physical condition which enable patients to be fit for a pharmacokinetic sampling according to principal investigator evaluation.
Be willing and able to comply with study procedures for the duration of the study.
Able to understand and willing to sign written informed consent form.
The subjects who are at present, and who can remain drug naïve for at least 14 days prior to dosing and till the end of the study, including herbal supplements, nutraceuticals.
Refrain from taking grapefruit, grapefruit juice, orange fruit \& orange juice during the study period

Who cannot join

Female volunteers and male volunteers who are either <18 years or >40 years.
History of asthma, anaphylaxis or anaphylactoid reactions, severe allergic responses.
History of relevant atopy or drug hypersensitivity.
Known allergy to any component of RNV-166 oral capsule or its placebo (HPMC or cellulose microcrystalline).
History of major medical, psychiatric illness or surgery which, in the judgment of the investigator, puts them 'at risk' or is likely to modify their handling of the study drug.
Acute or chronic systemic disease or disorder (respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine).

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Impaired renal function defined by a creatinine clearance < 90 mL/min calculated using the Cockcroft-Gault equation5 (FDA Guidance for Industry: Pharmacokinetics in patients with Impaired Renal Function, March 2010).
History of nephritic colic and/or renal calculi.
History of drug abuse and/or regular use of tobacco- or nicotine-containing products >5/day within three months of the study.
History of alcohol consumption exceeding, (on average 21 drinks/week for men) within 6 months of the first dose of study medication.
Drinking excessive amounts of tea, coffee, chocolate and/or beverage containing caffeine (> 4 cups / day).
Vital signs with a clinically significant abnormality at screening.
ECG with a clinically significant abnormality at screening.
Laboratory test values outside the clinically acceptable 'normal range' for healthy volunteers at screening.
Positive HIV, Hepatitis B or Hepatitis C, Tuberculosis, COVID-19 at screening.
Positive urine drug test or positive breath alcohol test at screening or at admission to the clinical unit.
Any medication (including St John's Wort) within 14 days before administration, or within 5 times the elimination half-life of that drug, whichever is the longest.
Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to dosing.
Unable to refrain from consumption of grapefruit and grapefruit juice, orange fruit \& orange juice within 7 days prior to the first dose of study medication.
Unwillingness to abstain from sexual intercourse with pregnant or lactating women or to use a condom and spermicide and another form of contraception (e.g., IUD, birth control pills taken by female partner, diaphragm with spermicide) if engaging in sexual intercourse with a woman who could become pregnant until discharge from the study and during 90 additional days.
Subjects unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator.
Subject being in the exclusion period of a previous trial.
Subject who could not be contacted in case of emergency.
Subject refusing to give written informed consent.
Subject who has received blood or plasma derivatives in the year preceding the study.
Subject who has given blood within the past 3 months or have planned to give blood or sperm within the 90 days following the study.
Subject who has forfeited their freedom by administrative or legal award, or who is under guardianship or under limited judicial protection.

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

Rajshahi Medical College Hospital
Rajshahi, 6000

Other trials in Bangladesh

About this study

Official title: A Randomized, Double-Blind, Placebo-controlled, Single-Ascending-Dose and Multiple-Ascending-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RNV-166 in Healthy Male Volunteers

This Phase 1 first-in-human clinical study evaluated the safety, tolerability, and pharmacokinetics of RNV-166 following single ascending dose (SAD) and multiple ascending dose (MAD) administration in healthy participants. Single oral doses of RNV-166 ranging from 200 mg to 1600 mg were assessed, including evaluation under fed (high-fat meal) conditions to characterize food effects on pharmacokinetics. Multiple ascending doses were administered once daily for up to 28 days to assess safety, tolerability, and pharmacokinetic profile following repeated dosing.

Conditions: First in Man Study to Evaluate Initial Safety
Being tested: RNV-166_200 mg, Placebo

What participants receive

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

RNV-166_200 mgDrug
RNV-166 will be formulated as 200 mg capsules, participants of different cohorts will administer the appropriate number of capsules to meet the dose of the cohort
PlaceboDrug
Placebo capsules will be identical to RNV-166 200 mg capsules, participants of different cohorts will administer the appropriate number of capsules to meet the dose of the cohort

Study groups in NCT07809360
Study group	Role	What they receive
SAD Group 1	Experimental	Random allocation to placebo or active RNV-166- 200 mg Receives: Drug: RNV-166_200 mg; Drug: Placebo
SAD Group 2	Experimental	Random allocation to placebo or active RNV-166- 400 mg Receives: Drug: RNV-166_200 mg; Drug: Placebo
SAD Group 3	Experimental	Random allocation to placebo or active RNV-166- 800 mg Receives: Drug: RNV-166_200 mg; Drug: Placebo
SAD Group 4	Experimental	Random allocation to placebo or active RNV-166- 1200 mg Receives: Drug: RNV-166_200 mg; Drug: Placebo
SAD Group 5	Experimental	Random allocation to placebo or active RNV-166- 1600 mg Receives: Drug: RNV-166_200 mg; Drug: Placebo
SAD Group 6	Experimental	Random allocation to placebo or active RNV-166- 1600 mg (Food effect cohort) Receives: Drug: RNV-166_200 mg; Drug: Placebo
MAD Group 1	Experimental	Random allocation to placebo or active RNV-166- 200 mg Receives: Drug: RNV-166_200 mg; Drug: Placebo
MAD Group 2	Experimental	Random allocation to placebo or active RNV-166- 800 mg capsules Receives: Drug: RNV-166_200 mg; Drug: Placebo
MAD Group 3	Experimental	Random allocation to placebo or active RNV-166- 1600 mg Receives: Drug: RNV-166_200 mg; Drug: Placebo

What is being measured

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

Safety- Treatment Emergent Adverse Events
Number and type of treatment emergent adverse events (TEAE) following RNV-166 administration will be assessed
Measured: Day 1 through Day 7-10 (SAD) or Day 40-46 (MAD)
Evaluations of clinical laboratory and changes from baseline will be assessed using descriptive statistics following RNV-166 administration
Laboratory values include hematology, biochemistry, clinical chemistry, coagulation, and urinalysis
Measured: Day 1 through Day 7-10 (SAD) or Day 40-46 (MAD)
Evaluations of 12-lead ECG parameter of heart rate (number of heart beats per minute) and changes from baseline will be assessed using descriptive statistics following RNV-166 administration
ECG parameters include heart rate (number of heart beats per minute)
Measured: Day 1 through Day 7-10 (SAD) or Day 40-46 (MAD)
Evaluations of vital signs and changes from baseline with respect to body temperature (in degree Fahrenheit) will be assessed using descriptive statistics following RNV-166 administration
Vital signs include body temperature (in degree Fahrenheit)
Measured: Day 1 through Day 7-10 (SAD) or Day 40-46 (MAD)
Evaluations of 12-lead ECG parameter of PR interval (milliseconds) and changes from baseline will be assessed using descriptive statistics following RNV-166 administration
ECG parameters include PR interval (milliseconds)
Measured: Day 1 through Day 7-10 (SAD) or Day 40-46 (MAD)
Evaluations of 12-lead ECG parameter of QRS duration (milliseconds) and changes from baseline will be assessed using descriptive statistics following RNV-166 administration
ECG parameters include QRS duration (milliseconds)
Measured: Day 1 through Day 7-10 (SAD) or Day 40-46 (MAD)
Evaluations of 12-lead ECG parameter of QT interval (milliseconds) and changes from baseline will be assessed using descriptive statistics following RNV-166 administration
ECG parameters include QT interval (milliseconds)
Measured: Day 1 through Day 7-10 (SAD) or Day 40-46 (MAD)
Evaluations of 12-lead ECG parameter of QTcF interval (milliseconds) and changes from baseline will be assessed using descriptive statistics following RNV-166 administration
ECG parameters include QTcF interval (milliseconds)
Measured: Day 1 through Day 7-10 (SAD) or Day 40-46 (MAD)
Evaluations of vital signs- respiratory rate (breathes per minute) and changes from baseline will be assessed using descriptive statistics following RNV-166 administration
Vital signs include respiratory rate (breathes per minute)
Measured: Day 1 through Day 7-10 (SAD) or Day 40-46 (MAD)
Evaluations of vital signs- blood pressure (mmHg) and changes from baseline will be assessed using descriptive statistics following RNV-166 administration
Vital signs include blood pressure (mmHg)
Measured: Day 1 through Day 7-10 (SAD) or Day 40-46 (MAD)
Evaluations of vital signs- radial pulse (beats per minute) and changes from baseline will be assessed using descriptive statistics following RNV-166 administration
Vital signs include radial pulse (beats per minute)
Measured: Day 1 through Day 7-10 (SAD) or Day 40-46 (MAD)

Secondary outcomes (5)

Maximum plasma concentration (Cmax)
Measured: SAD: Up to Day 2, 48 hours post dose; MAD: up to Day 28, 36 hours post last dose
Area under the plasma concentration versus time curve (AUC)
Measured: SAD: Up to Day 2, 48 hours post dose; MAD: up to Day 28, 36 hours post last dose
Time to maximum concentration (Tmax)
Measured: SAD: Up to Day 2, 48 hours post dose; MAD: up to Day 28, 36 hours post last dose
Terminal elimination half-life (t1/2)
Measured: SAD: Up to Day 2, 48 hours post dose; MAD: up to Day 28, 36 hours post last dose
Apparent oral plasma clearance (CL/F)
Measured: SAD: Up to Day 2, 48 hours post dose; MAD: up to Day 28, 36 hours post last dose

Timeline

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

22 Aug 20245 Feb 2025

First posted9 Sep 2026
Study start22 Aug 2024
Primary completion29 Sep 2024
Study completion5 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for First in Man Study to Evaluate Initial SafetyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: Phase 1- First in human studies evaluating safety and pharmacokinetic profile of Single ascending dose (SAD) and Multiple ascending dose (MAD) evaluations
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07809360
Sponsor's protocol ID: iVRS-CD-23-027
Status last verified: Sep 2026
First submitted: 10 Feb 2026
Last updated: 9 Sep 2026
Results posted: No
Data monitoring committee: Yes
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 First in Man Study to Evaluate Initial Safety trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-controlled, Single-Ascending-Dose and Multiple-Ascending-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RNV-166 in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT07809360
Acronym / sponsor ID: iVRS-CD-23-027
Conditions: First in Man Study to Evaluate Initial Safety
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: InVitro Research Solutions Private LimitedResearch network
Study start: 22 Aug 2024 (actual)
Primary completion: 29 Sep 2024 (actual)
Study completion: 5 Feb 2025 (actual)
First posted: 9 Sep 2026 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 9
Model description: Phase 1- First in human studies evaluating safety and pharmacokinetic profile of Single ascending dose (SAD) and Multiple ascending dose (MAD) evaluations

Arm	Type	Receives
SAD Group 1	Experimental	Drug: RNV-166_200 mg, Drug: PlaceboRandom allocation to placebo or active RNV-166- 200 mg
SAD Group 2	Experimental	Drug: RNV-166_200 mg, Drug: PlaceboRandom allocation to placebo or active RNV-166- 400 mg
SAD Group 3	Experimental	Drug: RNV-166_200 mg, Drug: PlaceboRandom allocation to placebo or active RNV-166- 800 mg
SAD Group 4	Experimental	Drug: RNV-166_200 mg, Drug: PlaceboRandom allocation to placebo or active RNV-166- 1200 mg
SAD Group 5	Experimental	Drug: RNV-166_200 mg, Drug: PlaceboRandom allocation to placebo or active RNV-166- 1600 mg
SAD Group 6	Experimental	Drug: RNV-166_200 mg, Drug: PlaceboRandom allocation to placebo or active RNV-166- 1600 mg (Food effect cohort)
MAD Group 1	Experimental	Drug: RNV-166_200 mg, Drug: PlaceboRandom allocation to placebo or active RNV-166- 200 mg
MAD Group 2	Experimental	Drug: RNV-166_200 mg, Drug: PlaceboRandom allocation to placebo or active RNV-166- 800 mg capsules
MAD Group 3	Experimental	Drug: RNV-166_200 mg, Drug: PlaceboRandom allocation to placebo or active RNV-166- 1600 mg

Who may qualify

Ages: 18 to 40 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (13 listed)

Healthy Male subjects between 18 and 40 years of age (both inclusive).
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECG. A subject with a clinically significant abnormality or laboratory parameters significantly outside the reference range for the population being studied may be included only if according to the investigator's opinion, the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
AST, ALT, alkaline phosphatase and bilirubin ≤1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Non-smoker and non-tobacco user.
No history or current practice of alcohol/substance/drug use.

Key exclusion criteria (27 listed)

Female volunteers and male volunteers who are either <18 years or >40 years.
History of asthma, anaphylaxis or anaphylactoid reactions, severe allergic responses.
History of relevant atopy or drug hypersensitivity.
Known allergy to any component of RNV-166 oral capsule or its placebo (HPMC or cellulose microcrystalline).
History of major medical, psychiatric illness or surgery which, in the judgment of the investigator, puts them 'at risk' or is likely to modify their handling of the study drug.

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
RNV-166_200 mgRNV-166 will be formulated as 200 mg capsules, participants of different cohorts will administer the appropriate number of capsules to meet the dose of the cohort	Drug	MAD Group 1, MAD Group 2, MAD Group 3, SAD Group 1, SAD Group 2, SAD Group 3, SAD Group 4, SAD Group 5, SAD Group 6
PlaceboPlacebo capsules will be identical to RNV-166 200 mg capsules, participants of different cohorts will administer the appropriate number of capsules to meet the dose of the cohort	Drug	MAD Group 1, MAD Group 2, MAD Group 3, SAD Group 1, SAD Group 2, SAD Group 3, SAD Group 4, SAD Group 5, SAD Group 6

Primary outcome

Safety- Treatment Emergent Adverse Events
Time frame: Day 1 through Day 7-10 (SAD) or Day 40-46 (MAD)
Number and type of treatment emergent adverse events (TEAE) following RNV-166 administration will be assessed
Evaluations of clinical laboratory and changes from baseline will be assessed using descriptive statistics following RNV-166 administration
Time frame: Day 1 through Day 7-10 (SAD) or Day 40-46 (MAD)
Laboratory values include hematology, biochemistry, clinical chemistry, coagulation, and urinalysis
Evaluations of 12-lead ECG parameter of heart rate (number of heart beats per minute) and changes from baseline will be assessed using descriptive statistics following RNV-166 administration
Time frame: Day 1 through Day 7-10 (SAD) or Day 40-46 (MAD)
ECG parameters include heart rate (number of heart beats per minute)
Evaluations of vital signs and changes from baseline with respect to body temperature (in degree Fahrenheit) will be assessed using descriptive statistics following RNV-166 administration
Time frame: Day 1 through Day 7-10 (SAD) or Day 40-46 (MAD)
Vital signs include body temperature (in degree Fahrenheit)
Evaluations of 12-lead ECG parameter of PR interval (milliseconds) and changes from baseline will be assessed using descriptive statistics following RNV-166 administration
Time frame: Day 1 through Day 7-10 (SAD) or Day 40-46 (MAD)
ECG parameters include PR interval (milliseconds)
Evaluations of 12-lead ECG parameter of QRS duration (milliseconds) and changes from baseline will be assessed using descriptive statistics following RNV-166 administration
Time frame: Day 1 through Day 7-10 (SAD) or Day 40-46 (MAD)
ECG parameters include QRS duration (milliseconds)
Evaluations of 12-lead ECG parameter of QT interval (milliseconds) and changes from baseline will be assessed using descriptive statistics following RNV-166 administration
Time frame: Day 1 through Day 7-10 (SAD) or Day 40-46 (MAD)
ECG parameters include QT interval (milliseconds)
Evaluations of 12-lead ECG parameter of QTcF interval (milliseconds) and changes from baseline will be assessed using descriptive statistics following RNV-166 administration
Time frame: Day 1 through Day 7-10 (SAD) or Day 40-46 (MAD)
ECG parameters include QTcF interval (milliseconds)
Evaluations of vital signs- respiratory rate (breathes per minute) and changes from baseline will be assessed using descriptive statistics following RNV-166 administration
Time frame: Day 1 through Day 7-10 (SAD) or Day 40-46 (MAD)
Vital signs include respiratory rate (breathes per minute)
Evaluations of vital signs- blood pressure (mmHg) and changes from baseline will be assessed using descriptive statistics following RNV-166 administration
Time frame: Day 1 through Day 7-10 (SAD) or Day 40-46 (MAD)
Vital signs include blood pressure (mmHg)
Evaluations of vital signs- radial pulse (beats per minute) and changes from baseline will be assessed using descriptive statistics following RNV-166 administration
Time frame: Day 1 through Day 7-10 (SAD) or Day 40-46 (MAD)
Vital signs include radial pulse (beats per minute)

5 secondary outcomes

Maximum plasma concentration (Cmax)
Time frame: SAD: Up to Day 2, 48 hours post dose; MAD: up to Day 28, 36 hours post last dose
Area under the plasma concentration versus time curve (AUC)
Time frame: SAD: Up to Day 2, 48 hours post dose; MAD: up to Day 28, 36 hours post last dose
Time to maximum concentration (Tmax)
Time frame: SAD: Up to Day 2, 48 hours post dose; MAD: up to Day 28, 36 hours post last dose
Terminal elimination half-life (t1/2)
Time frame: SAD: Up to Day 2, 48 hours post dose; MAD: up to Day 28, 36 hours post last dose
Apparent oral plasma clearance (CL/F)
Time frame: SAD: Up to Day 2, 48 hours post dose; MAD: up to Day 28, 36 hours post last dose

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 9 Sep 2026.
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.

Dr Biswajit Nag, Ph.D study chair

Renovel Innovations

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 RNV-166_200 mg in people with First in Man Study to Evaluate Initial Safety, run by InVitro Research Solutions Private Limited at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 27 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 9 Sep 2026. 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 Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety- Treatment Emergent Adverse Events (time frame: Day 1 through Day 7-10 (SAD) or Day 40-46 (MAD)). The study lists 11 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 NCT07809360.

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 9 Sep 2026.