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L'essai clinique NCT07489482 pour Diabète sucré est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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HENGRUI PHARMAA Clinical Study Comparing the Relative Bioavailability and Safety of SHR-3167 Injection Phase I 60 Randomisé Ouvert
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07489482 est conçu pour étudier le traitement de Diabète sucré. Il s'agit d'une étude interventionnel en Phase I. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 1 mars 2026, avec un objectif de 60 participants. Dirigée par HENGRUI PHARMA, l'étude devrait être terminée d'ici le 1 décembre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 24 mars 2026.
Résumé succinct
This study is a randomized, parallel, open-label Phase I clinical trial aimed at comparing the bioavailability and safety of different specifications of SHR-3167 injection, with healthy subjects as the research subjects.
Titre officiel
A Randomized, Parallel, Open-label Clinical Study on the Bioavailability and Safety of Different Specifications of SHR-3167 Injection in Healthy Subjects
Pathologies
Diabète sucréAutres identifiants de l'étude
- SHR-3167-106
Numéro NCT
Date de début (réel)
2026-03
Dernière mise à jour publiée
2026-03-24
Date de fin (estimée)
2026-12
Inscription (estimée)
60
Type d'étude
Interventionnel
PHASE
Phase I
Statut
Pas encore en recrutement
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalSHR-3167 Injection - Specification A Group | SHR-3167 Injection SHR-3167 injection, different specifications. |
ExpérimentalSHR-3167 Injection - Specification B Group | SHR-3167 Injection SHR-3167 injection, different specifications. |
ExpérimentalSHR-3167 Injection - Specification C Group | SHR-3167 Injection SHR-3167 injection, different specifications. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
The maximum plasma concentration (Cmax) | Day 1 - Day 71. | |
The area under the blood drug concentration-time curve corresponding from time 0 to the last quantifiable concentration time (AUC0-t) | Day 1 - Day 71. | |
The area under the blood drug concentration-time curve from time 0 to infinity (AUC0-∞) | Day 1 - Day 71. |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Time to maximum plasma concentration (Tmax) | Day 1 - Day 71. | |
Terminal half-life (t1/2) | Day 1 - Day 71. | |
Apparent volume of distribution (Vz/F) | Day 1 - Day 71. | |
Safety: Incidence and severity of adverse events (AEs) | Day 1 - Day 71. | |
Anti-SHR-3167 antibody (ADA) | Day 1; Day 22; Day 71. | |
Apparent clearance (CL/F) | Day 1 - Day 71. |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte
Âge minimum
18 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
- Male or female: 18 years old to 55 years old (on the day of signing the informed consent form).
- For healthy subjects, the body mass index (BMI) should be between 19.0 kg/m² and 26.0 kg/m², and the weight of men should be ≥ 50 kg and that of women ≥ 45 kg.
- Those who show no abnormalities through physical examination, vital signs, 12-lead electrocardiogram, frontal and lateral chest radiographs and laboratory tests, or have minor abnormalities but are judged by the researcher to have no clinical significance.
- Female subjects of childbearing potential or male subjects whose partners are of childbearing potential must have no plans for conception or sperm/egg donation from the time of signing the informed consent form until 4 months after the last dose, and must voluntarily refrain from unprotected sexual activity within 14 days before the screening period and use effective contraceptive measures (including partners) during the study period; female subjects of childbearing potential must have no unprotected sexual activity in the past 14 days, have a negative pregnancy test during the screening period, and not be in the lactation period.
- During the screening process, the fasting blood glucose should be between 3.9 mmol/L and 6.1 mmol/L, and the glycated hemoglobin (HbA1c) should be no more than 6.0%.
- Understand the research procedures and methods, voluntarily participate and have the ability to comply with the requirements of the trial protocol to complete this trial, and sign the informed consent form in person.
- Those with a history of frequent allergies or allergic diseases, or those who, as judged by the researcher, may be allergic to the study drug or its components or foods, etc.
- Those who have previously suffered from respiratory system, circulatory system, digestive system, urinary system, mental, nervous system, blood system, endocrine system, immune system or malignant tumor diseases, and who, based on the investigator's judgment, are not suitable to participate in this trial.
- Exclude those who had severe infections, severe injuries or surgeries within the previous 12 weeks, or those who plan to undergo surgery during the trial.
- Exclude those who have participated in any clinical trials of other drugs or medical devices within the previous 3 months prior to screening, or those who are still within 5 half-lives of the trial drug at the time of screening (whichever is longer).
- Exclude those who have used any medication (including prescription drugs, over-the-counter drugs, herbal medicines, patent medicines, health supplements, etc.) within the previous 2 weeks up to the time of randomization.
- Positive results were obtained for hepatitis B surface antigen (HBsAg), HIV antibody, Treponema pallidum specific antibody, or hepatitis C virus antibody tests; or the investigator judged that the subject was in the latent or active stage of the aforementioned infections.
- Exclude those who have a history of blood donation within the past 12 weeks, or have suffered from severe blood loss (blood loss ≥ 400 mL), or have received blood transfusion within the past 12 weeks.
- Those who received live (attenuated) vaccines within the previous 1 month or are scheduled to receive such vaccines during the trial process.
- Those who have a history of drug use or substance abuse; or those who tested positive for drugs in the baseline visit.
- Those who have difficulty in venous blood collection or whose physical condition does not allow for blood collection; or those who are expected not to comply well with the protocol or complete the entire trial follow-up.
- Persons with incomplete civil capacity and without a valid guardian.
- The researchers determined that any physical or psychological condition or illness that might increase the risk of the trial, affect the subjects' compliance with the protocol, or prevent the subjects from completing the trial.
HENGRUI PHARMA143 essais cliniques actifs à explorerContact central de l'étude
Contact: Yanli Dong, +86-0518-82342973, [email protected]
Contact: Weijie Kong, +86-0518-82342973, [email protected]
1 Centres de l'étude dans 1 pays
Hunan
Xiangya Hospital, Central South University, Changsha, Hunan, 410008, China
Gan Zhou, Contact, +86-0731-89753401, [email protected]
Gan Zhou, Investigateur principal