A Phase I Study of INT-210 Capsules in Healthy Adult Subjects (INT-210-I101) (INT-210-I101)
27 maj 2026 uppdaterad av: 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;
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
86
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Beijing, Kina
- Beijing Municipality - Beijing Municipality - No. 101, Luyuan East Road, Tongzhou District, Beijing
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Single Ascending Dose from 50 mg to 800 mg
Single Ascending Dose
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400 mg INT-210; Oral administration
Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration
Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
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Experimentell: Food Effect: 400mg
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400 mg INT-210; Oral administration
Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration
Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
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Experimentell: Multiple Ascending Dose: 200 mg to 600mg
BID
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400 mg INT-210; Oral administration
Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration
Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
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Placebo-jämförare: Placebo
Placebo for SAD, MAD and Food Effect
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INT-210 Placebo BID
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The incidence of treatment-emergent adverse events
Tidsram: From Day 1 through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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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.
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From Day 1 through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically- significant abnormalities in safety laboratory parameters-hematology
Tidsram: 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
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: coagulation
Tidsram: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Activated partial thromboplastin time, Prothrombin time, International Normalized Ratio, Fibrinogen
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: serum chemistry
Tidsram: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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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)
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: urinalysis
Tidsram: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Specific gravity, PH, Glucose, Protein, Nitrite , Urobilinogen, Occult Blood, White blood cells, Ketones, Red blood cells
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in electrocardiogram values: QTcF (milliseconds)
Tidsram: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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ECG assessment (QTcF) as determined by the Investigator/consulting board-certified cardiologist
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in vital signs: heart rate (beats per minute)
Tidsram: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in vital signs: blood pressure (mmHg)
Tidsram: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in vital signs: respiration rate (BPM)
Tidsram: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in vital signs: hemoglobin saturation (%)
Tidsram: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in vital signs: temperature (℃)
Tidsram: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Pharmacokinetics parameter: Cmax of INT-210
Tidsram: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Maximum observed plasma concentration (ng/mL)
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Pharmacokinetics parameter: Tmax of INT-210
Tidsram: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Time of maximum observed concentration (Tmax) of INT-210
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Pharmacokinetics parameter: AUC (0-T) of INT-210
Tidsram: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Area Under the concentration-time curve from dosing to the time of the last measured concentration (AUC0-T) (h*ng/L) of INT-210
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Pharmacokinetics parameter: T1/2 of INT-210
Tidsram: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Half-life (T1/2) (hours) of INT-210
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Pharmacokinetics parameter: CL/F of INT-210
Tidsram: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Apparent clearance (L/h) of INT-210
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Pharmacokinetics parameter: Vz/F of INT-210
Tidsram: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Apparent volume of distribution (L) of INT-210
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Pharmacokinetics parameter: AUCinf of INT-210
Tidsram: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Area under the curve from time 0 extrapolated to infinite time (AUCinf) (h*ng/L) of INT-210
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Potential risk of QT/QTc interval prolongation of INT-210
Tidsram: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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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".
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Fraction excreted: Fraction of drug excreted unchanged in urine and Feces
Tidsram: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Fraction of dose excreted unchanged into urine and feces as a percentage (%)
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
4 september 2025
Primärt slutförande (Faktisk)
6 januari 2026
Avslutad studie (Faktisk)
6 januari 2026
Studieregistreringsdatum
Först inskickad
24 april 2026
Först inskickad som uppfyllde QC-kriterierna
27 maj 2026
Första postat (Faktisk)
1 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- INT-210-I101
- CTR20253467 (Annan identifierare: National Medical Products Administration (NMPA))
Läkemedels- och apparatinformation, studiedokument
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Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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