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

27 mei 2026 bijgewerkt door: Innatus Therapeutics (Shanghai) Co., Ltd.

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;

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

86

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Single Ascending Dose from 50 mg to 800 mg
Single Ascending Dose
Geneesmiddel: INT-210 Capsule
400 mg INT-210; Oral administration
Geneesmiddel: INT-210 Capsule
Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration
Geneesmiddel: INT-210 Capsule
Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
Experimenteel: Food Effect: 400mg
Geneesmiddel: INT-210 Capsule
400 mg INT-210; Oral administration
Geneesmiddel: INT-210 Capsule
Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration
Geneesmiddel: INT-210 Capsule
Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
Experimenteel: Multiple Ascending Dose: 200 mg to 600mg
BID
Geneesmiddel: INT-210 Capsule
400 mg INT-210; Oral administration
Geneesmiddel: INT-210 Capsule
Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration
Geneesmiddel: INT-210 Capsule
Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
Placebo-vergelijker: Placebo
Placebo for SAD, MAD and Food Effect
Geneesmiddel: INT-210 Placebo
INT-210 Placebo BID

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The incidence of treatment-emergent adverse events
Tijdsspanne: 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.
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
Tijdsspanne: 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
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
Tijdsspanne: 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
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
Tijdsspanne: 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)
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
Tijdsspanne: 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
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)
Tijdsspanne: 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
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)
Tijdsspanne: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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)
Tijdsspanne: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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)
Tijdsspanne: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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 (%)
Tijdsspanne: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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 (℃)
Tijdsspanne: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pharmacokinetics parameter: Cmax of INT-210
Tijdsspanne: 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)
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
Tijdsspanne: 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
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
Tijdsspanne: 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
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
Tijdsspanne: 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
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
Tijdsspanne: 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
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
Tijdsspanne: 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
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
Tijdsspanne: 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
SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Potential risk of QT/QTc interval prolongation of INT-210
Tijdsspanne: 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".
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
Tijdsspanne: 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 (%)
SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Innatus Therapeutics (Shanghai) Co., Ltd.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

4 september 2025

Primaire voltooiing (Werkelijk)

6 januari 2026

Studie voltooiing (Werkelijk)

6 januari 2026

Studieregistratiedata

Eerst ingediend

24 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 mei 2026

Eerst geplaatst (Werkelijk)

1 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

27 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • INT-210-I101
  • CTR20253467 (Andere identificatie: National Medical Products Administration (NMPA))

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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