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Completed

NCT Number: NCT07616791

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

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Key information

Conditions

IBD (Inflammatory Bowel Disease) Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

INT-210 Capsule

Drug

400 mg INT-210; Oral administration

INT-210 Placebo

Drug

INT-210 Placebo BID

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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)

  5. 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

  6. 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

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

Secondary outcomes

  1. 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

    Maximum observed plasma concentration (ng/mL)

  2. 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

    Time of maximum observed concentration (Tmax) of INT-210

  3. 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

    Area Under the concentration-time curve from dosing to the time of the last measured concentration (AUC0-T) (h*ng/L) of INT-210

  4. 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

    Half-life (T1/2) (hours) of INT-210

  5. 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

    Apparent clearance (L/h) of INT-210

  6. 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

    Apparent volume of distribution (L) of INT-210

  7. 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

    Area under the curve from time 0 extrapolated to infinite time (AUCinf) (h*ng/L) of INT-210

Other outcomes

  1. Potential risk of QT/QTc interval prolongation 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

    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".

  2. Fraction excreted: Fraction of drug excreted unchanged in urine and Feces

    Time frame: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11

    Fraction of dose excreted unchanged into urine and feces as a percentage (%)

Sponsors and collaborators

Lead sponsor

Innatus Therapeutics (Shanghai) Co., Ltd.

Industry

Registry information

Official study 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

Acronym: INT-210-I101

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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