A Phase I Study of INT-210 Capsules in Healthy Adult Subjects (INT-210-I101) (INT-210-I101)
keskiviikko 27. toukokuuta 2026 päivittänyt: 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;
Tutkimuksen yleiskatsaus
Tila
Valmis
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
86
Vaihe
- Vaihe 1
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Beijing, Kiina
- Beijing Municipality - Beijing Municipality - No. 101, Luyuan East Road, Tongzhou District, Beijing
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Joo
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kolminkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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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Kokeellinen: 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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Kokeellinen: 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 Comparator: Placebo
Placebo for SAD, MAD and Food Effect
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INT-210 Placebo BID
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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The incidence of treatment-emergent adverse events
Aikaikkuna: 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
Aikaikkuna: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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 (%)
Aikaikkuna: 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 (℃)
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Pharmacokinetics parameter: Cmax of INT-210
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Potential risk of QT/QTc interval prolongation of INT-210
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
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Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- INT-210-I101
- CTR20253467 (Muu tunniste: National Medical Products Administration (NMPA))
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