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

NCT07616791 | Completed Phase 1

• 2 other identifiers: INT-210-I101CTR20253467
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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, 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)

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (7)

• Pharmacokinetics parameter: Cmax 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: 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

  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

  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

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

Other Outcomes (2)

• Potential risk of QT/QTc interval prolongation 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

• Fraction excreted: Fraction of drug excreted unchanged in urine and Feces

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

Study Arms (4)

Single Ascending Dose from 50 mg to 800 mg

EXPERIMENTAL

Single Ascending Dose

Drug: INT-210 Capsule

Food Effect: 400mg

EXPERIMENTAL

Drug: INT-210 Capsule

Multiple Ascending Dose: 200 mg to 600mg

EXPERIMENTAL

BID

Drug: INT-210 Capsule

Placebo

PLACEBO COMPARATOR

Placebo for SAD, MAD and Food Effect

Drug: INT-210 Placebo

Interventions

INT-210 Capsule DRUG

400 mg INT-210; Oral administration

Food Effect: 400mg

INT-210 Placebo DRUG

INT-210 Placebo BID

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Beijing, China

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: June 1, 2026
• Study Start: September 4, 2025
• Primary Completion: January 6, 2026
• Study Completion: January 6, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

CN (1)