HealthyPhase 1NCT06161090
Study of CM310 in Healthy Subjects
A Phase 1 study testing CM310 in people with Healthy, run by Keymed Biosciences Co.Ltd at 1 site in China.
Trial summary
This is a single center, randomized, double-blind, placebo-controlled, dose escalation 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?
- CM310
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2019to 13 Jan 2020
- 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
- Healthy male volunteers.
- aged ≥ 18 and ≤ 65 years old.
- With all clinical laboratory examination normal.
- Voluntary signing of the informed consent form.
Who cannot join
- With a history of asthma and allergic reactions.
- With a history of conjunctivitis and keratitis, as well as previous medical conditions.
- With positive results from alcohol breath or urine drug abuse testing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects
This is a single center, randomized, double-blind, placebo-controlled, dose escalation study.
- Conditions
- Healthy
- Being tested
- CM310, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM310Biological
CM310 injection
PlaceboDrug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Group 75 mg | Experimental | CM310 Recombinant Humanized Monoclonal Antibody Injection Receives: Biological: CM310 |
| Group 150 mg | Experimental | CM310 Recombinant Humanized Monoclonal Antibody Injection Receives: Biological: CM310 |
| Group 300 mg | Experimental | CM310 Recombinant Humanized Monoclonal Antibody Injection Receives: Biological: CM310 |
| Group 600 mg | Experimental | CM310 Recombinant Humanized Monoclonal Antibody Injection Receives: Biological: CM310 |
| Placebo | Placebo comparator | Placebo, Subcutaneous Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
Incidence of adverse events.
Measured: up to Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start3 Sep 2019
- Primary completion13 Jan 2020
- Study completion13 Jan 2020
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161090
- Sponsor's protocol ID
- CM310HV001
- Status last verified
- Nov 2023
- First submitted
- 29 Nov 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang L, Zhang W, Xu Y, Dong L, Sun Y, Jia Y, Li Z, Chen B, Hou J, Zhang J. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Stapokibart in Healthy Volunteers and Adult Subjects with Atopic Dermatitis. Adv Ther. 2024 Jul;41(7):2953-2965. doi: 10.1007/s12325-024-02887-w. Epub 2024 Jun 4.
PubMed 38833140
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06161090
- Acronym / sponsor ID
- CM310HV001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 13 Jan 2020 (actual)
- Study completion
- 13 Jan 2020 (actual)
- First posted
- 7 Dec 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 is a single center, randomized, double-blind, placebo-controlled, dose escalation study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 75 mg | Experimental | Biological: CM310CM310 Recombinant Humanized Monoclonal Antibody Injection |
| Group 150 mg | Experimental | Biological: CM310CM310 Recombinant Humanized Monoclonal Antibody Injection |
| Group 300 mg | Experimental | Biological: CM310CM310 Recombinant Humanized Monoclonal Antibody Injection |
| Group 600 mg | Experimental | Biological: CM310CM310 Recombinant Humanized Monoclonal Antibody Injection |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, Subcutaneous |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male volunteers.
- aged ≥ 18 and ≤ 65 years old.
- With all clinical laboratory examination normal.
- Voluntary signing of the informed consent form.
Key exclusion criteria (3 listed)
- With a history of asthma and allergic reactions.
- With a history of conjunctivitis and keratitis, as well as previous medical conditions.
- With positive results from alcohol breath or urine drug abuse testing.
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 |
|---|---|---|
| CM310CM310 injection | Biological | Group 150 mg, Group 300 mg, Group 600 mg, Group 75 mg |
| Placebosubcutaneous injection | Drug | Placebo |
Primary outcome
Adverse event
Time frame: up to Week 9
Incidence of adverse events.
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 7 Dec 2023.
- Derived from this study: PubMed 38833140Zhang L, Zhang W, Xu Y, Dong L, Sun Y, Jia Y, Li Z, Chen B, Hou J, Zhang J. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Stapokibart in Healthy Volunteers and Adult Subjects with Atopic Dermatitis. Adv Ther. 2024 Jul;41(7):2953-2965. doi: 10.1007/s12325-024-02887-w. Epub 2024 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
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 CM310 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 4 inclusion and 3 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 7 Dec 2023. 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. Some participants in this study may receive a placebo. 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?
Adverse event (time frame: up to Week 9). 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 NCT06161090, 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 7 Dec 2023.