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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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

192

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske 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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: CM326 group 1
Subjects will receive a single subcutaneous injection of CM326 on Day 1.
subcutaneous injection
Eksperimentell: CM326 group 2
Subjects will receive a single subcutaneous injection of CM326 on Day 1.
subcutaneous injection

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

20. april 2026

Primær fullføring (Antatt)

1. oktober 2026

Studiet fullført (Antatt)

31. desember 2026

Datoer for studieregistrering

Først innsendt

14. april 2026

Først innsendt som oppfylte QC-kriteriene

23. april 2026

Først lagt ut (Faktiske)

30. april 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. april 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • CM326-006

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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