Healthy VolunteersPhase 1NCT07415304
A Phase 1 Study of ISM4808 in Healthy Adult Subjects
A Phase 1 study testing ISM4808 in people with Healthy Volunteers, run by TaiGen Biotechnology Co., Ltd..
Trial summary
This is a Phase I, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), food effect, and QTc effects of single and multiple ascending oral doses of ISM4808 in healthy adult 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 Volunteers
- What is being tested?
- ISM4808
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 13 Feb 2026to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- • Able and willing to provide written informed consent and comply with all study procedures.
- Healthy male or female adults aged 18 to 55 years at the time of informed consent.
- Body mass index (BMI) 19-26 kg/m²; body weight ≥50 kg (males) and ≥45 kg (females).
- Medically healthy with no clinically significant abnormalities in medical history, physical examination, vital signs, laboratory tests, or 12-lead ECG, as determined by the investigator.
- Women of childbearing potential and male subjects with partners of childbearing potential must agree to use effective contraception from screening through 3 months after the last dose of investigational product.
Who cannot join
- History or presence of any clinically significant disease (including cardiovascular, neurological, psychiatric, gastrointestinal, hepatic, renal, hematologic, endocrine, or immune disorders) that may interfere with study participation or data interpretation.
- Personal or family history of clinically significant cardiac disease, including QT prolongation, torsades de pointes, myocardial infarction, heart failure, or sudden cardiac death.
- Use of medications known to prolong QT/QTc interval or treatment for clinically significant cardiac conditions.
- Screening 12-lead ECG abnormalities, including QTcF >450 ms (males) or >470 ms (females), PR interval >210 ms, QRS duration >110 ms, clinically significant arrhythmias, or uncontrolled hypertension.
- Participation in another interventional clinical trial or receipt of any investigational drug within 3 months prior to first dosing.
- Blood donation or significant blood loss (≥400 mL) within 3 months prior to first dosing.
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- Pregnant or breastfeeding women, or positive pregnancy test at screening or prior to dosing.
- Positive tests for HBsAg, HCV antibody, HIV antibody, or syphilis.
- History of drug or alcohol abuse, positive drug screen, or inability to abstain from alcohol, nicotine, or prohibited substances during the study.
- Use of prescription or non-prescription medications, herbal products, supplements, or vaccines within 28 days prior to dosing, unless approved by the investigator.
- Any condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral ISM4808 in Healthy Adult Subjects in China
This is a Phase I, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), food effect, and QTc effects of single and multiple ascending oral doses of ISM4808 in healthy adult subjects.
Read the detailed description
The study consists of two parts, Part 1 includes single ascending dose (SAD) and food effect (FE) assessments, FE assessments will be conducted in a selected dose cohort from the single ascending dose phase, using the same subjects after an appropriate washout period, AND Part 2 includes multiple ascending dose (MAD) evaluations. Safety, PK, PD, and concentration-QTc relationship will be assessed across dose levels.
Dose escalation decisions will be based on the review of available safety, tolerability, and pharmacokinetic data by a Safety Monitoring Committee.
- Conditions
- Healthy Volunteers
- Being tested
- ISM4808, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISM4808Drug
ISM4808 administered orally as capsules in single ascending dose and multiple ascending dose regimens, with flexible dosing schedules based on emerging safety and pharmacokinetic data.
PlaceboDrug
Matching placebo administered orally under the same conditions as ISM4808.
| Study group | Role | What they receive |
|---|---|---|
| ISM4808 | Experimental | Participants receive ISM4808 administered orally in single ascending dose and multiple ascending dose regimens. Receives: Drug: ISM4808 |
| Placebo | Placebo comparator | Participants receive matching placebo administered orally in single ascending dose and multiple ascending dose regimens. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
A TEAE is an adverse event (AE) occurrence in a subject who received study drug whether or not considered related to the study product.
Any adverse event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment is categorized as SAE.
The number of participants who experience at least one TEAE and SAE will be presented.
Measured: SAD/food-effect cohorts: From first dose up to Day 9; MAD cohorts: From first dose up to Day 18
Secondary outcomes (11)
Terminal elimination half-life (t1/2) of ISM4808
t1/2 is the time required for the plasma concentration of ISM4808 to decrease by half in the terminal phase. It is derived from the terminal slope of the concentration versus time curve
Measured: SAD/Food-effect cohorts: Pre-dose through 72 hours post-dose
Terminal elimination half-life (t1/2) of ISM4808
t1/2 is the time required for the plasma concentration of ISM4808 to decrease by half in the terminal phase. It is derived from the terminal slope of the concentration versus time curve
Measured: MAD cohorts: Day 1 and Day 10
Time to Maximum Observed Plasma Concentration (Tmax) of ISM4808
Tmax is the time at which the maximum observed plasma concentration (Cmax) is reached, determined directly from the plasma concentration-time data
Measured: SAD/Food-effect cohorts: Pre-dose through 72 hours post-dose
Time to Maximum Observed Plasma Concentration (Tmax) of ISM4808
Tmax is the time at which the maximum observed plasma concentration (Cmax) is reached, determined directly from the plasma concentration-time data
Measured: MAD cohorts: Day 1 and Day 10
Maximum Observed Plasma Concentration (Cmax) of ISM4808
Cmax will be derived directly from the plasma concentration-time profiles
Measured: SAD/Food-effect cohorts: Pre-dose through 72 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of ISM4808
Cmax will be derived directly from the plasma concentration-time profiles
Measured: MAD cohorts: Day 1 and Day 10
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of ISM4808
AUC0-t will be calculated using the linear-log trapezoidal method
Measured: SAD/Food-effect cohorts: Pre-dose through 72 hours post-dose
Area Under the Plasma Concentration-Time Curve within a dosing interval (AUC0-tau) of ISM4808
AUC0-tau is the area under the plasma concentration-time curve within the specified dosing interval, calculated using the linear-log trapezoidal method
Measured: MAD cohorts: Day 1 and Day 10
Average Steady-state Plasma Concentration (Cav) of ISM4808
Cav will be calculated as AUC 0- tau divided by the dosing interval tau
Measured: MAD cohorts: Day 1 and Day 10
Amount Excreted into Urine (Ae)of ISM4808
Ae is the total amount of unchanged drug excreted in the urine
Measured: MAD cohorts: 0-24 hours post dose on Day 10
Percentage of dose excreted in urine (Ae%) of ISM4808
The percentage of the administered dose that is excreted as unchanged drug in the urine
Measured: MAD cohorts: 0-24 hours post dose on Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start13 Feb 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to receive ISM4808 or placebo in parallel cohorts within single ascending dose (SAD) and multiple ascending dose (MAD) phases. A food effect (FE) assessment will be conducted in a selected dose cohort following an appropriate washout period using the same subjects in the single ascending dose cohorts.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TaiGen Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- R&G Pharma Studies Co.,Ltd.
- Responsible party
- Sponsor
- Investigators
- Gan Zhou, Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415304
- Sponsor's protocol ID
- ISM4808-101
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral ISM4808 in Healthy Adult Subjects in China
- ClinicalTrials.gov ID
- NCT07415304
- Acronym / sponsor ID
- ISM4808-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- TaiGen Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- R&G Pharma Studies Co.,Ltd.
- Study start
- 13 Feb 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Feb 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 is a Phase I, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), food effect, and QTc effects of single and multiple ascending oral doses of ISM4808 in healthy adult subjects.
Detailed description
The study consists of two parts, Part 1 includes single ascending dose (SAD) and food effect (FE) assessments, FE assessments will be conducted in a selected dose cohort from the single ascending dose phase, using the same subjects after an appropriate washout period, AND Part 2 includes multiple ascending dose (MAD) evaluations. Safety, PK, PD, and concentration-QTc relationship will be assessed across dose levels.
Dose escalation decisions will be based on the review of available safety, tolerability, and pharmacokinetic data by a Safety Monitoring Committee.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will be assigned to receive ISM4808 or placebo in parallel cohorts within single ascending dose (SAD) and multiple ascending dose (MAD) phases. A food effect (FE) assessment will be conducted in a selected dose cohort following an appropriate washout period using the same subjects in the single ascending dose cohorts.
| Arm | Type | Receives |
|---|---|---|
| ISM4808 | Experimental | Drug: ISM4808Participants receive ISM4808 administered orally in single ascending dose and multiple ascending dose regimens. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive matching placebo administered orally in single ascending dose and multiple ascending dose regimens. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Able and willing to provide written informed consent and comply with all study procedures.
Key exclusion criteria (11 listed)
- History or presence of any clinically significant disease (including cardiovascular, neurological, psychiatric, gastrointestinal, hepatic, renal, hematologic, endocrine, or immune disorders) that may interfere with study participation or data interpretation.
- Personal or family history of clinically significant cardiac disease, including QT prolongation, torsades de pointes, myocardial infarction, heart failure, or sudden cardiac death.
- Use of medications known to prolong QT/QTc interval or treatment for clinically significant cardiac conditions.
- Screening 12-lead ECG abnormalities, including QTcF >450 ms (males) or >470 ms (females), PR interval >210 ms, QRS duration >110 ms, clinically significant arrhythmias, or uncontrolled hypertension.
- Participation in another interventional clinical trial or receipt of any investigational drug within 3 months prior to first dosing.
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 |
|---|---|---|
| ISM4808ISM4808 administered orally as capsules in single ascending dose and multiple ascending dose regimens, with flexible dosing schedules based on emerging safety and pharmacokinetic data. | Drug | ISM4808 |
| PlaceboMatching placebo administered orally under the same conditions as ISM4808. | Drug | Placebo |
Primary outcome
Number of Participants With treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: SAD/food-effect cohorts: From first dose up to Day 9; MAD cohorts: From first dose up to Day 18
A TEAE is an adverse event (AE) occurrence in a subject who received study drug whether or not considered related to the study product. Any adverse event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment is categorized as SAE. The number of participants who experience at least one TEAE and SAE will be presented.
11 secondary outcomes
Terminal elimination half-life (t1/2) of ISM4808
Time frame: SAD/Food-effect cohorts: Pre-dose through 72 hours post-dose
Terminal elimination half-life (t1/2) of ISM4808
Time frame: MAD cohorts: Day 1 and Day 10
Time to Maximum Observed Plasma Concentration (Tmax) of ISM4808
Time frame: SAD/Food-effect cohorts: Pre-dose through 72 hours post-dose
Time to Maximum Observed Plasma Concentration (Tmax) of ISM4808
Time frame: MAD cohorts: Day 1 and Day 10
Maximum Observed Plasma Concentration (Cmax) of ISM4808
Time frame: SAD/Food-effect cohorts: Pre-dose through 72 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of ISM4808
Time frame: MAD cohorts: Day 1 and Day 10
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of ISM4808
Time frame: SAD/Food-effect cohorts: Pre-dose through 72 hours post-dose
Area Under the Plasma Concentration-Time Curve within a dosing interval (AUC0-tau) of ISM4808
Time frame: MAD cohorts: Day 1 and Day 10
Average Steady-state Plasma Concentration (Cav) of ISM4808
Time frame: MAD cohorts: Day 1 and Day 10
Amount Excreted into Urine (Ae)of ISM4808
Time frame: MAD cohorts: 0-24 hours post dose on Day 10
Percentage of dose excreted in urine (Ae%) of ISM4808
Time frame: MAD cohorts: 0-24 hours post dose on Day 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Screening Protocol
Pain
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.
Gan Zhou principal investigator
Xiangya Hospital of Central South University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ISM4808 in people with Healthy Volunteers, run by TaiGen Biotechnology Co., Ltd..
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 5 inclusion and 11 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: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li-Wen Chang (+886-2-8177-7020 227 ext. 1227, lwchang@taigenbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (time frame: SAD/food-effect cohorts: From first dose up to Day 9; MAD cohorts: From first dose up to Day 18). 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 17 Feb 2026.