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.
Trial summary
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. Read more about this study
- 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.
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- InVitro Research Solutions Private Limited
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Dr Biswajit Nag, Ph.D, Study chair, Renovel Innovations
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
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
- 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.
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.
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?
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.