Healthy SubjectsPhase 1NCT06012578
Study Evaluating ISM5411 Administered Orally to Healthy Volunteers
A Phase 1 study testing ISM5411 in people with Healthy Subjects, run by InSilico Medicine Hong Kong Limited at 1 site in Australia.
Trial summary
The goal of this clinical trial is to learn about ISM5411 in healthy subjects. The primary objective is to evaluate the safety and tolerability of single and multiple oral doses of ISM5411 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- ISM5411
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteAustralia
- Study dates
- 8 Nov 2023to 4 Sep 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who have signed the informed consent form (ICF) prior to the study, fully understand the content, procedures and possible adverse reactions of the study, and are able to complete the study in accordance with the protocol requirements.
- Subjects (including their partners) who have no plan to become pregnant and voluntarily use effective contraception as described in section 8.1 from screening to 3 months after the last dose.
- Male and female subjects aged 18-55 years (inclusive).
- Body weight ≥50 kg for males and ≥45 kg for females, with a body mass index (BMI = weight (kg)/height2 (m2)) of 18 ~ 32 kg/m2 (inclusive).
Who cannot join
- Allergy to the IP or any of its ingredients, or allergic constitution (allergy to more than 1 drugs and food).
- History of dysphagia or any gastrointestinal surgery (appendicectomy and cholecystectomy are excluded) or disease that affects drug absorption and/or elimination.
- Presence of clinically relevant diseases evidenced by clinical findings, which are making implementation of the protocol or interpretation of the study results difficult, or that would put the subject at risk by participating in the study in the opinion of the investigator, including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric or cardiovascular and cerebrovascular diseases).
- Presence of abnormal and clinically significant medical history, physical examination, vital signs, 12-lead ECG, clinical laboratory tests, abdominal color Doppler ultrasound, or other investigations at screening (Repeat testing will be allowed by the investigator discretion).
- Positive human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg) and hepatitis C antibody (HCV-Ab) in the viral serology testing at screening.
- Smoking > 5 cigarettes or an equivalent amount of tobacco per day, or consuming ≥ 14 units of alcohol per week (1 unit of alcohol ≈ 25 mL of spirits/100 mL of wine/285 mL of beer) within 1 months prior to screening or unwilling to abstain from smoking or drinking during the study.
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- Subjects who are positive for urine drug testing at screening or Day-1, or have a history of drug abuse or narcotic use in the past five years (Repeat testing will be allowed by the investigator discretion).
- Subjects who have donated blood or lost a significant amount of blood (>400 mL) within 1 months prior to screening, or who plan to donate blood during the study or within 1 month after the end of the study.
- Subjects who have undergone major surgical procedures (major visceral, organ, or bone surgeries) that may affect the study in the judgment of the investigator within 3 months prior to screening, or who intend to have such procedures during the study.
- Intolerance to vein puncture, or presence of a history of blood phobia or trypanophobia.
- Use of any prescription drugs within 14 days prior to the admission. Use of counter medication / vitamins / supplements within 7 days prior to admission (with the exception of contraception, occasional paracetamol, and standard dose of multivitamins).
- Subjects who have receipt of any study drug or participated in any medical device clinical studies within 1 month (or 5 half-lives, whichever is longer) prior to screening.
- Vaccination with any live or attenuated vaccine within 1 month prior to screening.
- Any acute disease or acute attack of any chronic disease within 28 days prior to screening.
- Consumption of any caffeinated food or beverages (such as coffee, strong tea, cola, chocolate, etc.), xanthine-rich food (such as anchovies, sardines, bovine liver, bovine kidney, etc.), food that induces or inhibits liver metabolizing enzymes (such as dragon fruits, mango, grapefruit, pomegranate, etc.) and beverages made thereof, or food or beverages containing alcohol, or presence of other factors that may affect the absorption, distribution, metabolism or excretion of the drug (such as strenuous exercise) within 48 hours prior to IP.
- Female subjects who are in lactation or positive for serum pregnancy test during the screening period or study course.
- Subjects who, in the judgment of the investigator, are not suitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Ascending Dose and Food Effect Study to Evaluate Safety, Tolerability, Pharmacokinetics and Food Effect of ISM5411 in Healthy Subjects
The goal of this clinical trial is to learn about ISM5411 in healthy subjects. The primary objective is to evaluate the safety and tolerability of single and multiple oral doses of ISM5411 in healthy subjects.
- Conditions
- Healthy Subjects
- Being tested
- ISM5411, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISM5411Drug
Investigational Drug
PlaceboDrug
ISM5411 Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| ISM5411 | Experimental | Not described Receives: Drug: ISM5411 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AEs) after single or multiple doses of ISM5411.
The number of participants with treatment related AEs as assessed by CTCAE v5.0. will be monitored.
Measured: Up to 7 days after last dose.
Number of participants with clinically significant changes in vital signs
The number of participants with clinically significant changes in vital signs will be monitored based on the assessment of blood pressure, heart rate, respiration and body temperature before and after administration.
Measured: Up to 7 days after last dose.
Number of participants with clinically significant changes in in chemistry laboratory values
The number of participants with clinically significant changes in blood routine, blood biochemistry, urine routine, coagulation function, etc. will be monitored before and after administration.
Measured: Up to 7 days after last dose
Number of participants with clinically significant changes in 12-lead Electrocardiogram (ECG) readings
The number of participants with clinically significant changes in 12-lead Electrocardiogram (ECG) readings will be monitored based on changes in cardiovascular system function (change in QTC parameters) as a criterion of safety and tolerability variables.
Measured: Up to 7 days after last dose
Number of participants with clinically significant changes in physical examinations
Complete physical examination should include the head and face, skin system, lymph nodes, eyes, ears, nose and throat, mouth, respiratory system, cardiovascular system, abdomen, musculoskeletal system, nervous system and mental status.
Measured: Up to 7 days after last dose
Secondary outcomes (13)
Maximum plasma concentration (Cmax) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Measured: Day 1 through Day 17
Time at which the maximum plasma concentration occurred (tmax) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Measured: Day 1 through Day 17
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Measured: Day 1 through Day 17
Area under the plasma concentration-time curve from time zero to time with last measurable concentration t (AUC0-t) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Measured: Day 1 through Day 17
Elimination rate constant (λz) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Measured: Day 1 through Day 17
Elimination half-life (t1/2) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Measured: Day 1 through Day 17
Apparent volume of distribution (Vz/F) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Measured: Day 1 through Day 17
Apparent total plasma clearance (CL/F) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Measured: Day 1 through Day 17
Mean residence time (MRT) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Measured: Day 1 through Day 17
Renal clearance rate (CLR) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Measured: Day 1 through Day 17
Accumulative excretion (Ae) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Measured: Day 1 through Day 17
Fractional excretion (fe) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Measured: Day 1 through Day 17
Relative bioavailability (fed/fasted) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Measured: Day 1 through Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start8 Nov 2023
- Primary completion4 Sep 2024
- Study completion4 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSilico Medicine Hong Kong Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012578
- Sponsor's protocol ID
- ISM5411-101
- Status last verified
- Nov 2024
- First submitted
- 17 Aug 2023
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Ascending Dose and Food Effect Study to Evaluate Safety, Tolerability, Pharmacokinetics and Food Effect of ISM5411 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06012578
- Acronym / sponsor ID
- ISM5411-101
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- InSilico Medicine Hong Kong LimitedIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 4 Sep 2024 (actual)
- Study completion
- 4 Sep 2024 (actual)
- First posted
- 25 Aug 2023 (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.
The goal of this clinical trial is to learn about ISM5411 in healthy subjects. The primary objective is to evaluate the safety and tolerability of single and multiple oral doses of ISM5411 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ISM5411 | Experimental | Drug: ISM5411 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects who have signed the informed consent form (ICF) prior to the study, fully understand the content, procedures and possible adverse reactions of the study, and are able to complete the study in accordance with the protocol requirements.
- Subjects (including their partners) who have no plan to become pregnant and voluntarily use effective contraception as described in section 8.1 from screening to 3 months after the last dose.
- Male and female subjects aged 18-55 years (inclusive).
- Body weight ≥50 kg for males and ≥45 kg for females, with a body mass index (BMI = weight (kg)/height2 (m2)) of 18 ~ 32 kg/m2 (inclusive).
Key exclusion criteria (17 listed)
- Allergy to the IP or any of its ingredients, or allergic constitution (allergy to more than 1 drugs and food).
- History of dysphagia or any gastrointestinal surgery (appendicectomy and cholecystectomy are excluded) or disease that affects drug absorption and/or elimination.
- Presence of clinically relevant diseases evidenced by clinical findings, which are making implementation of the protocol or interpretation of the study results difficult, or that would put the subject at risk by participating in the study in the opinion of the investigator, including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric or cardiovascular and cerebrovascular diseases).
- Presence of abnormal and clinically significant medical history, physical examination, vital signs, 12-lead ECG, clinical laboratory tests, abdominal color Doppler ultrasound, or other investigations at screening (Repeat testing will be allowed by the investigator discretion).
- Positive human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg) and hepatitis C antibody (HCV-Ab) in the viral serology testing at screening.
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 |
|---|---|---|
| ISM5411Investigational Drug | Drug | ISM5411 |
| PlaceboISM5411 Matching Placebo | Drug | Placebo |
Primary outcome
Number of participants with Adverse Events (AEs) after single or multiple doses of ISM5411.
Time frame: Up to 7 days after last dose.
The number of participants with treatment related AEs as assessed by CTCAE v5.0. will be monitored.
Number of participants with clinically significant changes in vital signs
Time frame: Up to 7 days after last dose.
The number of participants with clinically significant changes in vital signs will be monitored based on the assessment of blood pressure, heart rate, respiration and body temperature before and after administration.
Number of participants with clinically significant changes in in chemistry laboratory values
Time frame: Up to 7 days after last dose
The number of participants with clinically significant changes in blood routine, blood biochemistry, urine routine, coagulation function, etc. will be monitored before and after administration.
Number of participants with clinically significant changes in 12-lead Electrocardiogram (ECG) readings
Time frame: Up to 7 days after last dose
The number of participants with clinically significant changes in 12-lead Electrocardiogram (ECG) readings will be monitored based on changes in cardiovascular system function (change in QTC parameters) as a criterion of safety and tolerability variables.
Number of participants with clinically significant changes in physical examinations
Time frame: Up to 7 days after last dose
Complete physical examination should include the head and face, skin system, lymph nodes, eyes, ears, nose and throat, mouth, respiratory system, cardiovascular system, abdomen, musculoskeletal system, nervous system and mental status.
13 secondary outcomes
Maximum plasma concentration (Cmax) of ISM5411
Time frame: Day 1 through Day 17
Time at which the maximum plasma concentration occurred (tmax) of ISM5411
Time frame: Day 1 through Day 17
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of ISM5411
Time frame: Day 1 through Day 17
Area under the plasma concentration-time curve from time zero to time with last measurable concentration t (AUC0-t) of ISM5411
Time frame: Day 1 through Day 17
Elimination rate constant (λz) of ISM5411
Time frame: Day 1 through Day 17
Elimination half-life (t1/2) of ISM5411
Time frame: Day 1 through Day 17
Apparent volume of distribution (Vz/F) of ISM5411
Time frame: Day 1 through Day 17
Apparent total plasma clearance (CL/F) of ISM5411
Time frame: Day 1 through Day 17
Mean residence time (MRT) of ISM5411
Time frame: Day 1 through Day 17
Renal clearance rate (CLR) of ISM5411
Time frame: Day 1 through Day 17
Accumulative excretion (Ae) of ISM5411
Time frame: Day 1 through Day 17
Fractional excretion (fe) of ISM5411
Time frame: Day 1 through Day 17
Relative bioavailability (fed/fasted) of ISM5411
Time frame: Day 1 through Day 17
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 7 Nov 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 ISM5411 in people with Healthy Subjects, run by InSilico Medicine Hong Kong Limited 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 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. 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?
Number of participants with Adverse Events (AEs) after single or multiple doses of ISM5411. (time frame: Up to 7 days after last dose.). The study lists 5 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 7 Nov 2024.