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

27. maj 2026 opdateret af: 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;

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

86

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Single Ascending Dose from 50 mg to 800 mg
Single Ascending Dose
Medicin: INT-210 Capsule
400 mg INT-210; Oral administration
Medicin: INT-210 Capsule
Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration
Medicin: INT-210 Capsule
Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
Eksperimentel: Food Effect: 400mg
Medicin: INT-210 Capsule
400 mg INT-210; Oral administration
Medicin: INT-210 Capsule
Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration
Medicin: INT-210 Capsule
Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
Eksperimentel: Multiple Ascending Dose: 200 mg to 600mg
BID
Medicin: INT-210 Capsule
400 mg INT-210; Oral administration
Medicin: INT-210 Capsule
Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration
Medicin: INT-210 Capsule
Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
Placebo komparator: Placebo
Placebo for SAD, MAD and Food Effect
Medicin: INT-210 Placebo
INT-210 Placebo BID

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The incidence of treatment-emergent adverse events
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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 (%)
Tidsramme: 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 (℃)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pharmacokinetics parameter: Cmax of INT-210
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Potential risk of QT/QTc interval prolongation of INT-210
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Innatus Therapeutics (Shanghai) Co., Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. september 2025

Primær færdiggørelse (Faktiske)

6. januar 2026

Studieafslutning (Faktiske)

6. januar 2026

Datoer for studieregistrering

Først indsendt

24. april 2026

Først indsendt, der opfyldte QC-kriterier

27. maj 2026

Først opslået (Faktiske)

1. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • INT-210-I101
  • CTR20253467 (Anden identifikator: National Medical Products Administration (NMPA))

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med INT-210 Capsule

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