A Comparative Pharmacokinetic Study of CM326 in Healthy Subjects

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-55
SponsorCSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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;

Healthy male participants aged 18 to 55 years;

Body weight between 55.0 and 85.0 kg, and body mass index between 19.0 and 26.0 kg/m²;

Physical examination, vital signs, 12-lead electrocardiogram, laboratory tests, and other examination results are normal, or abnormal but without clinical significance;

Disqualifiers

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.;

Presence or suspicion of any active viral, bacterial, fungal, or parasitic infection within 14 days before dosing;

Participants who have undergone major surgery within 3 months before screening, or who plan to undergo major surgery during the study period;

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;

Trial design

Treatments tested in this trial

  • CM326(formulation 1)
  • CM326(formulation 2)

Treatment groups

192 Participants
are divided into 2 treatment groups

Locations

This trial has no locations