IBD (Inflammatory Bowel Disease)Phase 1INT-210-I101NCT07616791
A Phase I Study of INT-210 Capsules in Healthy Adult Subjects (INT-210-I101)
A Phase 1 study testing INT-210 Capsule in people with IBD (Inflammatory Bowel Disease), run by Innatus Therapeutics (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
A Phase Ⅰ, Single and Multiple Ascending Dose escalation, and Food-Effect Study of the Safety, Tolerability and Pharmacokinetics of INT-210 Capsules in Healthy Adult Voluteers. Primary Objectives: ● To assess the safety and tolerability of single and multiple oral dose of INT-210 capsules in healthy adult voluteers… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- IBD (Inflammatory Bowel Disease)
- What is being tested?
- INT-210 Capsule
- 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
- 1 siteChina
- Study dates
- 4 Sep 2025to 6 Jan 2026
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female healthy voluteers
- Aged 18-45 years(inclusive),
- In good general health with no evidence of active or chronic disease; and who agree to comply with the prescribed contraceptive requirement during the trial and for 3 months after the last dose.
Who cannot join
- Female who are pregnant or breastfeeding; or planing pregnancy, female of chidbearing potential not using adequate contraception.
- Pre-existing significant medical conditions(cardiac, hepatic, renal, gastrointestina, etc), abnormal lab results, active infection, or history of special conditions like long QT syndrome or hypocalcemia.
- Positive screening for HIV, Hepatitis B/C or syphilis;
- Recent subject in another clinical trial;
- Recent major surgery, or significant blood loss.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Municipality - Beijing Municipality - No. 101, Luyuan East Road, Tongzhou District, Beijing
Beijing
About this study
Official title: A Phase I, Single and Multiple Ascending Dose Escalation, and Food-Effect Study of the Safety, Tolerability and Pharmacokinetics of INT-210 Capsules in Healthy Adult Subjects
A Phase Ⅰ, Single and Multiple Ascending Dose escalation, and Food-Effect Study of the Safety, Tolerability and Pharmacokinetics of INT-210 Capsules in Healthy Adult Voluteers.
Primary Objectives:
Read more
● To assess the safety and tolerability of single and multiple oral dose of INT-210 capsules in healthy adult voluteers,
Secondary Objectives:
- To assess the pharmacokinetic(PK) profile of single and multiple oral doses of INT-210 capsules in healthy adult voluteers;
- To assess the safety and tolerability of INT-210 capsulese administered under fasting and fed(high-fat-meal) conditions in healthy adult voluteers;
- To assess the effect of food on the PK profile of a single oral dose of INT-210 capsules in healthy adult voluteers;
- Conditions
- IBD (Inflammatory Bowel Disease)
- Being tested
- INT-210 Capsule, INT-210 Placebo
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INT-210 CapsuleDrug
400 mg INT-210; Oral administration
INT-210 CapsuleDrug
Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration
INT-210 CapsuleDrug
Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
INT-210 PlaceboDrug
INT-210 Placebo BID
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose from 50 mg to 800 mg | Experimental | Single Ascending Dose Receives: Drug: INT-210 Capsule |
| Food Effect: 400mg | Experimental | Not described Receives: Drug: INT-210 Capsule |
| Multiple Ascending Dose: 200 mg to 600mg | Experimental | BID Receives: Drug: INT-210 Capsule |
| Placebo | Placebo comparator | Placebo for SAD, MAD and Food Effect Receives: Drug: INT-210 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of treatment-emergent adverse events
Number of participants with treatment-related adverse events as assessed. The incidence of treatment-emergent adverse events will be measured using a combination of data collection methods, including tracking adverse events and assessing their onset or worsening relative to the initiation of treatment. The most recent version of the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms will be used to classify adverse events, including their relationship to the treatment and maximum severity.
Measured: From Day 1 through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
Treatment-emergent potentially clinically- significant abnormalities in safety laboratory parameters-hematology
Hemoglobin, Hematocrit, Erythrocytes, Mean corpuscular volume, Platelets, Leukocytes, Eosinophils, Basophils, Neutrophils, Lymphocytes, Monocytes
Measured: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: coagulation
Activated partial thromboplastin time, Prothrombin time, International Normalized Ratio, Fibrinogen
Measured: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: serum chemistry
Glucose, Blood urea nitrogen, Creatinine, Sodium, Potassium, Calcium, Chloride, Magnesium, Bicarbonate, Phosphate, Bilirubin, total and direct, Alkaline phosphatase, Aspartate transaminase (=SGOT), Alanine transaminase (=SGPT), Gamma glutamyl transferase, Total protein, Albumin, Creatine kinase, Lactate dehydrogenase (LDH)
Measured: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: urinalysis
Specific gravity, PH, Glucose, Protein, Nitrite , Urobilinogen, Occult Blood, White blood cells, Ketones, Red blood cells
Measured: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
Treatment-emergent potentially clinically significant abnormalities in electrocardiogram values: QTcF (milliseconds)
ECG assessment (QTcF) as determined by the Investigator/consulting board-certified cardiologist
Measured: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: heart rate (beats per minute)
Measured: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: blood pressure (mmHg)
Measured: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: respiration rate (BPM)
Measured: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: hemoglobin saturation (%)
Measured: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: temperature (℃)
Measured: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
Secondary outcomes (7)
Pharmacokinetics parameter: Cmax of INT-210
Maximum observed plasma concentration (ng/mL)
Measured: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
Pharmacokinetics parameter: Tmax of INT-210
Time of maximum observed concentration (Tmax) of INT-210
Measured: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
Pharmacokinetics parameter: AUC (0-T) of INT-210
Area Under the concentration-time curve from dosing to the time of the last measured concentration (AUC0-T) (h*ng/L) of INT-210
Measured: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
Pharmacokinetics parameter: T1/2 of INT-210
Half-life (T1/2) (hours) of INT-210
Measured: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
Pharmacokinetics parameter: CL/F of INT-210
Apparent clearance (L/h) of INT-210
Measured: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
Pharmacokinetics parameter: Vz/F of INT-210
Apparent volume of distribution (L) of INT-210
Measured: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
Pharmacokinetics parameter: AUCinf of INT-210
Area under the curve from time 0 extrapolated to infinite time (AUCinf) (h*ng/L) of INT-210
Measured: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start4 Sep 2025
- Primary completion6 Jan 2026
- Study completion6 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD (Inflammatory Bowel Disease)Studies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innatus Therapeutics (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616791
- Sponsor's protocol ID
- INT-210-I101
- Other IDs
- CTR20253467
- Acronym
- INT-210-I101
- Status last verified
- May 2026
- First submitted
- 24 Apr 2026
- Last updated
- 1 Jun 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 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single and Multiple Ascending Dose Escalation, and Food-Effect Study of the Safety, Tolerability and Pharmacokinetics of INT-210 Capsules in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07616791
- Acronym / sponsor ID
- INT-210-I101 / INT-210-I101
- Conditions
- IBD (Inflammatory Bowel Disease)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Innatus Therapeutics (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 6 Jan 2026 (actual)
- Study completion
- 6 Jan 2026 (actual)
- First posted
- 1 Jun 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.
A Phase Ⅰ, Single and Multiple Ascending Dose escalation, and Food-Effect Study of the Safety, Tolerability and Pharmacokinetics of INT-210 Capsules in Healthy Adult Voluteers.
Primary Objectives:
● To assess the safety and tolerability of single and multiple oral dose of INT-210 capsules in healthy adult voluteers,
Secondary Objectives:
- To assess the pharmacokinetic(PK) profile of single and multiple oral doses of INT-210 capsules in healthy adult voluteers;
- To assess the safety and tolerability of INT-210 capsulese administered under fasting and fed(high-fat-meal) conditions in healthy adult voluteers;
- To assess the effect of food on the PK profile of a single oral dose of INT-210 capsules in healthy adult voluteers;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose from 50 mg to 800 mg | Experimental | Drug: INT-210 CapsuleSingle Ascending Dose |
| Food Effect: 400mg | Experimental | Drug: INT-210 Capsule |
| Multiple Ascending Dose: 200 mg to 600mg | Experimental | Drug: INT-210 CapsuleBID |
| Placebo | Placebo comparator | Drug: INT-210 PlaceboPlacebo for SAD, MAD and Food Effect |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female healthy voluteers
- Aged 18-45 years(inclusive),
- In good general health with no evidence of active or chronic disease; and who agree to comply with the prescribed contraceptive requirement during the trial and for 3 months after the last dose.
Key exclusion criteria (5 listed)
- Female who are pregnant or breastfeeding; or planing pregnancy, female of chidbearing potential not using adequate contraception.
- Pre-existing significant medical conditions(cardiac, hepatic, renal, gastrointestina, etc), abnormal lab results, active infection, or history of special conditions like long QT syndrome or hypocalcemia.
- Positive screening for HIV, Hepatitis B/C or syphilis;
- Recent subject in another clinical trial;
- Recent major surgery, or significant blood loss.
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 |
|---|---|---|
| INT-210 Capsule400 mg INT-210; Oral administration | Drug | Food Effect: 400mg |
| INT-210 CapsuleEscalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration | Drug | Single Ascending Dose from 50 mg to 800 mg |
| INT-210 CapsuleEscalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration | Drug | Multiple Ascending Dose: 200 mg to 600mg |
| INT-210 PlaceboINT-210 Placebo BID | Drug | Placebo |
Primary outcome
The incidence of treatment-emergent adverse events
Time frame: From Day 1 through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
Number of participants with treatment-related adverse events as assessed. The incidence of treatment-emergent adverse events will be measured using a combination of data collection methods, including tracking adverse events and assessing their onset or worsening relative to the initiation of treatment. The most recent version of the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms will be used to classify adverse events, including their relationship to the treatment and maximum severity.
Treatment-emergent potentially clinically- significant abnormalities in safety laboratory parameters-hematology
Time frame: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
Hemoglobin, Hematocrit, Erythrocytes, Mean corpuscular volume, Platelets, Leukocytes, Eosinophils, Basophils, Neutrophils, Lymphocytes, Monocytes
Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: coagulation
Time frame: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
Activated partial thromboplastin time, Prothrombin time, International Normalized Ratio, Fibrinogen
Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: serum chemistry
Time frame: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
Glucose, Blood urea nitrogen, Creatinine, Sodium, Potassium, Calcium, Chloride, Magnesium, Bicarbonate, Phosphate, Bilirubin, total and direct, Alkaline phosphatase, Aspartate transaminase (=SGOT), Alanine transaminase (=SGPT), Gamma glutamyl transferase, Total protein, Albumin, Creatine kinase, Lactate dehydrogenase (LDH)
Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: urinalysis
Time frame: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
Specific gravity, PH, Glucose, Protein, Nitrite , Urobilinogen, Occult Blood, White blood cells, Ketones, Red blood cells
Treatment-emergent potentially clinically significant abnormalities in electrocardiogram values: QTcF (milliseconds)
Time frame: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
ECG assessment (QTcF) as determined by the Investigator/consulting board-certified cardiologist
Treatment-emergent potentially clinically significant abnormalities in vital signs: heart rate (beats per minute)
Time frame: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: blood pressure (mmHg)
Time frame: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: respiration rate (BPM)
Time frame: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: hemoglobin saturation (%)
Time frame: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: temperature (℃)
Time frame: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
7 secondary outcomes
Pharmacokinetics parameter: Cmax of INT-210
Time frame: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
Pharmacokinetics parameter: Tmax of INT-210
Time frame: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
Pharmacokinetics parameter: AUC (0-T) of INT-210
Time frame: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
Pharmacokinetics parameter: T1/2 of INT-210
Time frame: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
Pharmacokinetics parameter: CL/F of INT-210
Time frame: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
Pharmacokinetics parameter: Vz/F of INT-210
Time frame: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
Pharmacokinetics parameter: AUCinf of INT-210
Time frame: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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 1 Jun 2026.
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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 INT-210 Capsule in people with IBD (Inflammatory Bowel Disease), run by Innatus Therapeutics (Shanghai) Co., Ltd. at 1 site in China.
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 3 inclusion and 5 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 1 Jun 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 China. 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?
The incidence of treatment-emergent adverse events (time frame: From Day 1 through the safety follow-up visit on either Day 8 (SAD) or Day 21 (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 1 Jun 2026.