Not Yet RecruitingPhase 1

A Comparative Pharmacokinetic Study of CM326 in Healthy Subjects

192 participantsStarted 2026-04-20

Plain-language summary

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.

Who can participate

Age range18 Years – 55 Years

SexMALE

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Inclusion criteria

✓. 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;
✓. Participants and their partners agree to use effective and reliable contraceptive methods from signing the ICF until 3 months after dosing;
✓. Participants are able to communicate well with the investigator, and to understand and comply with the requirements of the study.

Exclusion criteria

✕. 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;
✕. Positive result for any of the following: hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, human immunodeficiency virus antigen/antibody;
✕. 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;
✕. Blood loss or blood donation of more than 200 mL within 3 months before screening;
✕. 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;

What they're measuring

Maximum concentration (Cmax)

Timeframe: Pre-dose at day 1 to Day 113

Area under the concentration-time curve from zero to infinity (AUCinf)

Timeframe: Pre-dose at day 1 to Day 113

Trial details

NCT IDNCT07560033

SponsorCSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-01

Contact for this trial

Clinical Trials Information Group officer

+86-0311-69085587 ctr-contact@cspc.cn

View on ClinicalTrials.gov More Healthy Subjects trials