A Phase I Study of INT-210 Capsules in Healthy Adult Subjects (INT-210-I101) (INT-210-I101)

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:

● 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 Overview

• Status: Completed
• Conditions: IBD (Inflammatory Bowel Disease)
• Intervention / Treatment: Drug: INT-210 Capsule; Drug: INT-210 Capsule; Drug: INT-210 Capsule; Drug: INT-210 Placebo

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Municipality - Beijing Municipality - No. 101, Luyuan East Road, Tongzhou District, Beijing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Ascending Dose from 50 mg to 800 mg; Single Ascending Dose	Drug: INT-210 Capsule; 400 mg INT-210; Oral administration; Drug: INT-210 Capsule; Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration; Drug: INT-210 Capsule; Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
Experimental: Food Effect: 400mg	Drug: INT-210 Capsule; 400 mg INT-210; Oral administration; Drug: INT-210 Capsule; Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration; Drug: INT-210 Capsule; Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
Experimental: Multiple Ascending Dose: 200 mg to 600mg; BID	Drug: INT-210 Capsule; 400 mg INT-210; Oral administration; Drug: INT-210 Capsule; Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration; Drug: INT-210 Capsule; Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
Placebo Comparator: Placebo; Placebo for SAD, MAD and Food Effect	Drug: INT-210 Placebo; INT-210 Placebo BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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)	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	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	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)		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)		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)		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 (%)		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 (℃)		From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics parameter: Cmax of INT-210	Maximum observed plasma concentration (ng/mL)	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	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	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	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	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	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	SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Potential risk of QT/QTc interval prolongation of INT-210	A correlation model will be constructed using drug concentrations and ECG parameters to analyze the concentration-QTc relationship, and the potential risk of QT/QTc interval prolongation will be assessed by establishing a "concentration-effect model".	SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
Fraction excreted: Fraction of drug excreted unchanged in urine and Feces	Fraction of dose excreted unchanged into urine and feces as a percentage (%)	SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11

Collaborators and Investigators

• Sponsor: Innatus Therapeutics (Shanghai) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2025
• Primary Completion (Actual): January 6, 2026
• Study Completion (Actual): January 6, 2026

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases
• Other Study ID Numbers: INT-210-I101; CTR20253467 (Other Identifier: National Medical Products Administration (NMPA))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No