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A Comparative Pharmacokinetic Study of CM326 in Healthy Subjects

A Randomized, Open-Label, Parallel-Controlled Phase I Study to Compare the Pharmacokinetics, Safety, and Immunogenicity of a Single Subcutaneous Injection of CM326 Via Different Delivery Devices in Healthy Subjects

This is a randomized, open-label, parallel-controlled study to compare the PK, safety, and immunogenicity of CM326 administered via different delivery devices in healthy subjects.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

192

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Clinical Trials Information Group officer
  • Telefonnummer: +86-0311-69085587
  • E-mail: ctr-contact@cspc.cn

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. Participants [c1.1]must be informed of the study before it begins, fully understand the study content, procedures, and potential adverse reactions, and voluntarily sign the written ICF;
  2. Healthy male participants aged 18 to 55 years;
  3. Body weight between 55.0 and 85.0 kg, and body mass index between 19.0 and 26.0 kg/m²;
  4. Physical examination, vital signs, 12-lead electrocardiogram, laboratory tests, and other examination results are normal, or abnormal but without clinical significance;
  5. Participants and their partners agree to use effective and reliable contraceptive methods from signing the ICF until 3 months after dosing;
  6. Participants are able to communicate well with the investigator, and to understand and comply with the requirements of the study.

Exclusion Criteria:

  1. History of chronic diseases or severe diseases involving the circulatory system, blood or hematopoietic system, respiratory system, endocrine system, urinary system, digestive system, immune system, psychiatric or nervous system, reproductive system, etc.;
  2. Presence or suspicion of any active viral, bacterial, fungal, or parasitic infection within 14 days before dosing;
  3. Participants who have undergone major surgery within 3 months before screening, or who plan to undergo major surgery during the study period;
  4. History of allergies to drugs, food, etc., or Participants who may be allergic to the study drug or its components in the Investigator's judgment;
  5. Positive result for any of the following: hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, human immunodeficiency virus antigen/antibody;
  6. History of drug abuse, or use of illicit drugs within 3 months before screening, or habitual use of any psychotropic drugs (including herbal medicines), or a positive urine drug screen;
  7. Blood loss or blood donation of more than 200 mL within 3 months before screening;
  8. Intolerance to subcutaneous injection, or presence of abdominal scars that affect subcutaneous administration, and any skin abnormalities and/or tattoos that may affect the safety assessment of the injection site;
  9. Use of any prescription drugs, over-the-counter drugs, herbal medicines or vitamin and dietary supplements within 14 days or 5 half-lives (whichever is longer) before dosing;
  10. Use of any marketed or investigational biological products within 6 months or 5 half-lives (whichever is longer) before dosing;
  11. Participants who have previously used CM326 or drugs targeting TSLP;
  12. Vaccination within 4 weeks before screening, or plan to receive such vaccines during the study;
  13. Participation in any clinical trial within 3 months before screening;
  14. Average daily smoking of more than 5 cigarettes within 3 months before screening, or unwilling to avoid using any tobacco products during the study;
  15. Regular alcohol consumption within 3 months before screening, defined as weekly alcohol consumption exceeding 14 units (1 unit = 360 mL of 5% alcohol beer or 45 mL of 40% alcohol spirits or 150 mL of 12% alcohol wine), or inability to stop alcohol intake during the study, or a positive blood alcohol test;
  16. Regular consumption of excessive amounts of tea, coffee, and/or caffeinated beverages within 3 months before screening;
  17. Participants who have special dietary requirements and are unable to comply with the standardized diet;
  18. History of needle phobia or hemophobia, or d difficulty with venipuncture or unable to tolerate venous puncture;
  19. Participants who, in the Investigator's judgment, may be unable to complete the study for other reasons or are considered unsuitable for enrollment.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CM326 group 1
Subjects will receive a single subcutaneous injection of CM326 on Day 1.
subcutaneous injection
Eksperimentel: CM326 group 2
Subjects will receive a single subcutaneous injection of CM326 on Day 1.
subcutaneous injection

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum concentration (Cmax)
Tidsramme: Pre-dose at day 1 to Day 113
To compare the Cmax of CM326 administered via different delivery devices
Pre-dose at day 1 to Day 113
Area under the concentration-time curve from zero to infinity (AUCinf)
Tidsramme: Pre-dose at day 1 to Day 113
To compare the AUCinf of CM326 administered via different delivery devices
Pre-dose at day 1 to Day 113

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to maximum concentration (Tmax)
Tidsramme: Pre-dose at day 1 to Day 113
To characterize the Tmax of CM326 in healthy subjects
Pre-dose at day 1 to Day 113
Area under the concentration-curve from zero to the last quantifiable concentration (AUClast)
Tidsramme: Pre-dose at day 1 to Day 113
To characterize the AUClast of CM326 in healthy subjects
Pre-dose at day 1 to Day 113
Terminal elimination half-life (t1/2)
Tidsramme: Pre-dose at day 1 to Day 113
To characterize the t1/2 of CM326 in healthy subjects
Pre-dose at day 1 to Day 113
Apparent clearance (CL/F)
Tidsramme: Pre-dose at day 1 to Day 113
To characterize the Vz/F of CM326 in healthy subjects
Pre-dose at day 1 to Day 113
Apparent volume of distribution (Vz/F)
Tidsramme: Pre-dose at day 1 to Day 113
To characterize the Vz/F of CM326 in healthy subjects
Pre-dose at day 1 to Day 113
Number of subjects with adverse events as Assessed by CTCAE v6.0
Tidsramme: Pre-dose at day 1 to Day 113
To assess the safety of CM326 in healthy subjects
Pre-dose at day 1 to Day 113
Incidence of ADA
Tidsramme: Pre-dose at day 1 to Day 113
To assess the immunogenicity of CM326 in healthy subjects
Pre-dose at day 1 to Day 113

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

20. april 2026

Primær færdiggørelse (Anslået)

1. oktober 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

14. april 2026

Først indsendt, der opfyldte QC-kriterier

23. april 2026

Først opslået (Faktiske)

30. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. april 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • CM326-006

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med CM326(formulation 1)

Abonner