HealthyPhase 1NCT06285227
Study of CM313 in Healthy Subjects
A Phase 1 study testing CM313 injection in people with Healthy, run by Keymed Biosciences Co.Ltd at 1 site in China.
Trial summary
This study is a single center, randomized, open/double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacokinetic characteristics, and immunogenicity of CM313 administered subcutaneously or intravenously at different… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CM313 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2024to 30 Apr 2025
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects age ≥ 18 years \& ≤50 years.
- Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.
Who cannot join
- With history of malignant tumors;
- Plan to undergo major surgery during the research period
- Known to be allergic to monoclonal antibody drugs or other related drugs, food, or CM313 excipients;
- With any voluntary blood donation or any other form of blood loss exceeding 400 mL;
- The average daily smoking volume within the first three months of screening is greater than 5 cigarettes;
- Positive results in baseline alcohol breath test or urine drug abuse screening.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital Fudan University
Shanghai
Qing Zhang
About this study
Official title: A Randomized, Open/Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM313 in Healthy Subjects With Single Subcutaneous Injection/Intravenous Infusion
This study is a single center, randomized, open/double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacokinetic characteristics, and immunogenicity of CM313 administered subcutaneously or intravenously at different doses in healthy male subjects.
- Conditions
- Healthy
- Being tested
- CM313 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM313 injectionBiological
CM313
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | CM313, subcutaneous injection, once Receives: Biological: CM313 injection |
| Group 2 | Experimental | CM313, subcutaneous injection, once Receives: Biological: CM313 injection |
| Group 3 | Experimental | CM313, subcutaneous injection, once Receives: Biological: CM313 injection |
| Group 4 | Experimental | CM313, infusion, once Receives: Biological: CM313 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
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 posted29 Feb 2024
- Study start12 Mar 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
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
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qing Zhang, Principal investigator, Huashan HospitalYu Xue, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285227
- Sponsor's protocol ID
- CM313-100001
- Status last verified
- Feb 2024
- First submitted
- 22 Feb 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yu S, Wu J, Zhao J, He J, Yan H, Zhang X, Yang Y, Song H, Hou Q, Guo B, Qiu Y, Chen B, Xue Y, Zhang J. Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM313 in Healthy Participants: An Open-Label/Double-Blind, Randomized, Placebo-Controlled Phase 1 Trial. Clin Transl Sci. 2025 Sep;18(9):e70334. doi: 10.1111/cts.70334.
PubMed 40965985
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open/Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM313 in Healthy Subjects With Single Subcutaneous Injection/Intravenous Infusion
- ClinicalTrials.gov ID
- NCT06285227
- Acronym / sponsor ID
- CM313-100001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 29 Feb 2024 (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, open/double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacokinetic characteristics, and immunogenicity of CM313 administered subcutaneously or intravenously 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: CM313 injectionCM313, subcutaneous injection, once |
| Group 2 | Experimental | Biological: CM313 injectionCM313, subcutaneous injection, once |
| Group 3 | Experimental | Biological: CM313 injectionCM313, subcutaneous injection, once |
| Group 4 | Experimental | Biological: CM313 injectionCM313, infusion, once |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects age ≥ 18 years \& ≤50 years.
- Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.
Key exclusion criteria (6 listed)
- With history of malignant tumors;
- Plan to undergo major surgery during the research period
- Known to be allergic to monoclonal antibody drugs or other related drugs, food, or CM313 excipients;
- With any voluntary blood donation or any other form of blood loss exceeding 400 mL;
- The average daily smoking volume within the first three months of screening is greater than 5 cigarettes;
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 |
|---|---|---|
| CM313 injectionCM313 | Biological | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Adverse event
Time frame: Up to week 12
Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Derived from this study: PubMed 40965985Yu S, Wu J, Zhao J, He J, Yan H, Zhang X, Yang Y, Song H, Hou Q, Guo B, Qiu Y, Chen B, Xue Y, Zhang J. Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM313 in Healthy Participants: An Open-Label/Double-Blind, Randomized, Placebo-Controlled Phase 1 Trial. Clin Transl Sci. 2025 Sep;18(9):e70334. doi: 10.1111/cts.70334.
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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.
Qing Zhang principal investigator
Huashan Hospital
Yu Xue principal investigator
Huashan 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 CM313 injection 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qian Jia (028-88610620, qianjia@keymedbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event (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 NCT06285227, 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 16 Oct 2024.