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

27 maggio 2026 aggiornato da: 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;

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

86

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Single Ascending Dose from 50 mg to 800 mg
Single Ascending Dose
Droga: INT-210 Capsule
400 mg INT-210; Oral administration
Droga: INT-210 Capsule
Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration
Droga: INT-210 Capsule
Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
Sperimentale: Food Effect: 400mg
Droga: INT-210 Capsule
400 mg INT-210; Oral administration
Droga: INT-210 Capsule
Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration
Droga: INT-210 Capsule
Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
Sperimentale: Multiple Ascending Dose: 200 mg to 600mg
BID
Droga: INT-210 Capsule
400 mg INT-210; Oral administration
Droga: INT-210 Capsule
Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration
Droga: INT-210 Capsule
Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
Comparatore placebo: Placebo
Placebo for SAD, MAD and Food Effect
Droga: INT-210 Placebo
INT-210 Placebo BID

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The incidence of treatment-emergent adverse events
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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 (%)
Lasso di tempo: 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 (℃)
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pharmacokinetics parameter: Cmax of INT-210
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Potential risk of QT/QTc interval prolongation of INT-210
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Innatus Therapeutics (Shanghai) Co., Ltd.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

4 settembre 2025

Completamento primario (Effettivo)

6 gennaio 2026

Completamento dello studio (Effettivo)

6 gennaio 2026

Date di iscrizione allo studio

Primo inviato

24 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 maggio 2026

Primo Inserito (Effettivo)

1 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • INT-210-I101
  • CTR20253467 (Altro identificatore: National Medical Products Administration (NMPA))

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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