HealthyPhase 1NCT05715333
Study of CM326 Injection in Healthy Subjects
A Phase 1 study testing CM326 in people with Healthy, run by Keymed Biosciences Co.Ltd at 1 site in China.
Trial summary
This study is a single-center, randomized, double-blind, placebo-controlled, dose-increasing phase I clinical study. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CM326
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2023to 4 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤ 65 years, healthy male.
- With normal or abnormal laboratory test results without clinical significanceat screening period and baseline.
- Subjects can communicate well with investigators and comply with protocol requirements.
Who cannot join
- Any live attenuated vaccine is planned to be inoculated 30 days before administration or during the study period.
- Major surgery is planned during the study period.
- The average daily smoking volume is more than 5 cigarettes within 3 months before screening.
- Within 12 weeks before administration, blood loss from voluntary blood donation or any attempt to visit is greater than 400 mL.
- There are any reasons that the investigator believes will prevent the subject from participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Immunogenicity of CM326 Injection in Healthy Subjects
This study is a single-center, randomized, double-blind, placebo-controlled, dose-increasing phase I clinical study.
Read the detailed description
The purpose of this study is to evaluate the safety, tolerance, pharmacokinetics and immunogenicity of single and multiple subcutaneous administration of CM326 at different doses in healthy male subjects.
- Conditions
- Healthy
- Being tested
- CM326, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM326Biological
CM326 Injection
PlaceboOther
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | CM326 220 mg/2 mL or matched placebo, subcutaneous at low dose Receives: Biological: CM326; Other: Placebo |
| Group 2 | Experimental | CM326 220mg/2 mL or matched placebo, subcutaneous at medium dose Receives: Biological: CM326; Other: Placebo |
| Group 3 | Experimental | CM326 220mg/2mL or matched placebo, subcutaneous at high dose Receives: Biological: CM326; Other: Placebo |
| Group 4 | Experimental | CM326 220mg/2mL or matched placebo, subcutaneous at medium dose Receives: Biological: CM326; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency adverse events during treatment
By assessing the number and severity of adverse events during the study.
Measured: Up to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start21 Mar 2023
- Primary completion4 Oct 2023
- Study completion4 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Keymed Biosciences Co.LtdThe sponsor's other registered studies.
- 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jie Hou, Principal investigator, Peking University Care Luzhong HospitalHong Wang, Principal investigator, Peking University Care Luzhong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715333
- Sponsor's protocol ID
- CM326-100003
- Status last verified
- Mar 2023
- First submitted
- 27 Jan 2023
- Last updated
- 8 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Di Y, Yang L, Zhou J, Zhang L, Huang Y, Jia Y, Yan H, Chen L, Hou Q, Chen B, Luo Z, Hou J. Translational Investigation of CM326 from Preclinical Studies to Randomized Phase I Clinical Trials in Healthy Adults. BioDrugs. 2025 May;39(3):487-498. doi: 10.1007/s40259-025-00714-4. Epub 2025 Apr 4.
PubMed 40185989
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Immunogenicity of CM326 Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05715333
- Acronym / sponsor ID
- CM326-100003
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 4 Oct 2023 (actual)
- Study completion
- 4 Oct 2023 (actual)
- First posted
- 8 Feb 2023 (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 study is a single-center, randomized, double-blind, placebo-controlled, dose-increasing phase I clinical study.
Detailed description
The purpose of this study is to evaluate the safety, tolerance, pharmacokinetics and immunogenicity of single and multiple subcutaneous administration of CM326 at different doses in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: CM326, Other: PlaceboCM326 220 mg/2 mL or matched placebo, subcutaneous at low dose |
| Group 2 | Experimental | Biological: CM326, Other: PlaceboCM326 220mg/2 mL or matched placebo, subcutaneous at medium dose |
| Group 3 | Experimental | Biological: CM326, Other: PlaceboCM326 220mg/2mL or matched placebo, subcutaneous at high dose |
| Group 4 | Experimental | Biological: CM326, Other: PlaceboCM326 220mg/2mL or matched placebo, subcutaneous at medium dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years and ≤ 65 years, healthy male.
- With normal or abnormal laboratory test results without clinical significanceat screening period and baseline.
- Subjects can communicate well with investigators and comply with protocol requirements.
Key exclusion criteria (5 listed)
- Any live attenuated vaccine is planned to be inoculated 30 days before administration or during the study period.
- Major surgery is planned during the study period.
- The average daily smoking volume is more than 5 cigarettes within 3 months before screening.
- Within 12 weeks before administration, blood loss from voluntary blood donation or any attempt to visit is greater than 400 mL.
- There are any reasons that the investigator believes will prevent the subject from participating in the study.
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 |
|---|---|---|
| CM326CM326 Injection | Biological | Group 1, Group 2, Group 3, Group 4 |
| PlaceboSubcutaneous injection | Other | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Emergency adverse events during treatment
Time frame: Up to week 12
By assessing the number and severity of adverse events during the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Derived from this study: PubMed 40185989Di Y, Yang L, Zhou J, Zhang L, Huang Y, Jia Y, Yan H, Chen L, Hou Q, Chen B, Luo Z, Hou J. Translational Investigation of CM326 from Preclinical Studies to Randomized Phase I Clinical Trials in Healthy Adults. BioDrugs. 2025 May;39(3):487-498. doi: 10.1007/s40259-025-00714-4. Epub 2025 Apr 4.
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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. This study is not recruiting at the moment.
Jie Hou principal investigator
Peking University Care Luzhong Hospital
Hong Wang principal investigator
Peking University Care Luzhong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CM326 in people with Healthy, run by Keymed Biosciences Co.Ltd at 1 site in China.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergency adverse events during treatment (time frame: Up to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05715333, which also lists 1 linked publication.
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 8 Nov 2024.