beta
Trial Radar IA
Lo studio clinico NCT07495930 per Health Adult Subjects è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
Un studio corrisponde ai criteri del filtro
Vista a schede
Torna alla ricerca

A Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 and EU-Phesgo®. Fase I 24

Non ancora in arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07495930 è uno studio interventistico di Fase I volto a esaminare il trattamento per Health Adult Subjects, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 30 aprile 2026, con l'obiettivo di raggiungere 24 partecipanti. Sotto la guida di Shanghai Henlius Biotech, dovrebbe concludersi entro il 10 ottobre 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 27 marzo 2026.
Sommario breve
The study is being conducted to compare the pharmacokinetic (PK) parameters of HLX319 and EU-Phesgo® after a single subcutaneous administration in healthy male subjects in China, providing a basis for the design of subsequent clinical study protocols.
Titolo ufficiale

A Randomized, Double-blind, Single Subcutaneous Administration, Parallel Control Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 and EU-Phesgo® in Chinese Healthy Male Subjects.

Patologie
Health Adult Subjects
Altri ID dello studio
  • HLX319-001
Numero NCT
NCT07495930
Data di inizio (effettiva)
2026-04-30
Ultimo aggiornamento pubblicato
2026-03-27
Data di completamento (stimata)
2026-10-10
Arruolamento (previsto)
24
Tipo di studio
Interventistico
FASE
Fase I
Stato
Non ancora in arruolamento
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Doppio
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleHLX319 arm
subjects will receive a single subcutaneous injection of HLX319.
HLX319
HLX319 is a biosimilar of pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection).
Comparatore attivoEu-Phesgo arm
subjects will receive a single subcutaneous injection of Eu-Phesgo.
EU-Phesgo
EU-Phesgo is an original marketed drug product, with the generic name pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection).
Esito primario
Misure di esitoDescrizione della misuraArco temporale
AUC0-inf
Area-under-curve of blood drug concentration-time from time 0 to infinity after a single drug administration
up to 85 days
Cmax
Peak concentration after a single administration
up to 85 days
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
AUC0-t
Area-under-curve of the blood drug concentration-time curve from time zero to the last quantifiable concentration time
up to 85 days
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto
Età minima
18 Years
Sessi idonei
Maschio
Accetta volontari sani
Sì
  1. Male subjects aged ≥18 and ≤45 years;
  2. The skin at the injection site is intact, without damage, tattoos, or other markings;
  3. Subjects have no history of disease or past medical history abnormalities that, in the judgment of the study physician, would affect the trial;
  4. Physical examination, vital signs, chest x-ray, electrocardiogram, and laboratory investigations are normal or show abnormalities without clinical significance.
  5. Body weight (BW) ≥50 and ≤75 kg;
  6. Body mass index (BMI) ≥19 and ≤24 kg/m² \[BMI = weight (kg) / height² (m²)\];
  7. Within 14 days prior to random allocation, left ventricular ejection fraction (LVEF) assessed by echocardiography is within the normal range (≥55%);

  1. Clinically significant diseases including but not limited to the gastrointestinal tract, kidneys, liver, nerves, blood, endocrine system, tumors, respiratory system, immune system, mental health, and cardiovascular and cerebrovascular diseases;
  2. History of allergy or hypersensitivity reactions.
  3. Intake of prescription drugs, over-the-counter drugs, or traditional Chinese medicine within 28 days prior to randomization;
  4. History of blood donation or blood loss (>450mL) within 3 months prior to randomization;
  5. Positive test results for Hepatitis B Surface Antigen (HbsAg), Hepatitis C Virus (HCV) antibodies, and Human Immunodeficiency Virus (HIV) antibodies, or abnormal and clinically significant quantitative test results for syphilis spirochetes as determined by the sub investigator;
  6. History of upper respiratory tract infection or other acute infections within 2 weeks prior to r randomization;
  7. History of drug abuse, substance use;
  8. History of alcoholism or positive alcohol test results;

11. History of long-term heavy smoking .

Shanghai Henlius Biotech logoShanghai Henlius Biotech
Contatti principali dello studio
Contatto: qi Jin, 86 159 5516 0489, [email protected]
1 Centri dello studio in 1 paesi

Anhui

Anhui Medical University Second Affiliated Hospital, Hefei, Anhui, 230601, China
Wei Hu, Dr, Contatto, 0551-65997164, [email protected]