Healthy volunteers needed to test new injection method for experimental drug
NCT ID NCT07560033
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an experimental drug called CM326 in 192 healthy men aged 18 to 55. The goal is to see how the drug moves through the body and if it is safe when given through different injection devices. Participants will receive a single shot and be monitored for side effects and drug levels. This is an early-stage study with no direct treatment benefit.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 192 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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