Healthy SubjectsPhase 1NCT07560033
A Comparative Pharmacokinetic Study of CM326 in Healthy Subjects
A Phase 1 study testing CM326(formulation 1) and CM326(formulation 2) in people with Healthy Subjects, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- CM326(formulation 1) and CM326(formulation 2)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- 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;
- Use of any marketed or investigational biological products within 6 months or 5 half-lives (whichever is longer) before dosing;
- Participants who have previously used CM326 or drugs targeting TSLP;
- Vaccination within 4 weeks before screening, or plan to receive such vaccines during the study;
- Participation in any clinical trial within 3 months before screening;
- Average daily smoking of more than 5 cigarettes within 3 months before screening, or unwilling to avoid using any tobacco products during the study;
- 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;
- Regular consumption of excessive amounts of tea, coffee, and/or caffeinated beverages within 3 months before screening;
- Participants who have special dietary requirements and are unable to comply with the standardized diet;
- History of needle phobia or hemophobia, or d difficulty with venipuncture or unable to tolerate venous puncture;
- Participants who, in the Investigator's judgment, may be unable to complete the study for other reasons or are considered unsuitable for enrollment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Healthy Subjects
- Being tested
- CM326(formulation 1), CM326(formulation 2)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM326(formulation 1)Drug
subcutaneous injection
CM326(formulation 2)Drug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| CM326 group 1 | Experimental | Subjects will receive a single subcutaneous injection of CM326 on Day 1. Receives: Drug: CM326(formulation 1) |
| CM326 group 2 | Experimental | Subjects will receive a single subcutaneous injection of CM326 on Day 1. Receives: Drug: CM326(formulation 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax)
To compare the Cmax of CM326 administered via different delivery devices
Measured: Pre-dose at day 1 to Day 113
Area under the concentration-time curve from zero to infinity (AUCinf)
To compare the AUCinf of CM326 administered via different delivery devices
Measured: Pre-dose at day 1 to Day 113
Secondary outcomes (7)
Time to maximum concentration (Tmax)
To characterize the Tmax of CM326 in healthy subjects
Measured: Pre-dose at day 1 to Day 113
Area under the concentration-curve from zero to the last quantifiable concentration (AUClast)
To characterize the AUClast of CM326 in healthy subjects
Measured: Pre-dose at day 1 to Day 113
Terminal elimination half-life (t1/2)
To characterize the t1/2 of CM326 in healthy subjects
Measured: Pre-dose at day 1 to Day 113
Apparent clearance (CL/F)
To characterize the Vz/F of CM326 in healthy subjects
Measured: Pre-dose at day 1 to Day 113
Apparent volume of distribution (Vz/F)
To characterize the Vz/F of CM326 in healthy subjects
Measured: Pre-dose at day 1 to Day 113
Number of subjects with adverse events as Assessed by CTCAE v6.0
To assess the safety of CM326 in healthy subjects
Measured: Pre-dose at day 1 to Day 113
Incidence of ADA
To assess the immunogenicity of CM326 in healthy subjects
Measured: Pre-dose at day 1 to Day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560033
- Sponsor's protocol ID
- CM326-006
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07560033
- Acronym / sponsor ID
- CM326-006
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CM326 group 1 | Experimental | Drug: CM326(formulation 1)Subjects will receive a single subcutaneous injection of CM326 on Day 1. |
| CM326 group 2 | Experimental | Drug: CM326(formulation 2)Subjects will receive a single subcutaneous injection of CM326 on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CM326(formulation 1)subcutaneous injection | Drug | CM326 group 1 |
| CM326(formulation 2)subcutaneous injection | Drug | CM326 group 2 |
Primary outcome
Maximum concentration (Cmax)
Time frame: Pre-dose at day 1 to Day 113
To compare the Cmax of CM326 administered via different delivery devices
Area under the concentration-time curve from zero to infinity (AUCinf)
Time frame: Pre-dose at day 1 to Day 113
To compare the AUCinf of CM326 administered via different delivery devices
7 secondary outcomes
Time to maximum concentration (Tmax)
Time frame: Pre-dose at day 1 to Day 113
Area under the concentration-curve from zero to the last quantifiable concentration (AUClast)
Time frame: Pre-dose at day 1 to Day 113
Terminal elimination half-life (t1/2)
Time frame: Pre-dose at day 1 to Day 113
Apparent clearance (CL/F)
Time frame: Pre-dose at day 1 to Day 113
Apparent volume of distribution (Vz/F)
Time frame: Pre-dose at day 1 to Day 113
Number of subjects with adverse events as Assessed by CTCAE v6.0
Time frame: Pre-dose at day 1 to Day 113
Incidence of ADA
Time frame: Pre-dose at day 1 to Day 113
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CM326(formulation 1) and CM326(formulation 2) in people with Healthy Subjects, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (+86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum concentration (Cmax) (time frame: Pre-dose at day 1 to Day 113). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.