Atopic DermatitisPhase 1NCT06553209
Study of CM512 in Healthy Subjects and Patients With Atopic Dermatitis
A Phase 1 study testing CM512 in people with Atopic Dermatitis, run by Keymed Biosciences Co.Ltd at 1 site in China.
Trial summary
This is a randomized, double-blind, single/multiple dose escalation, placebo-controlled phase I study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in healthy subjects and patients with moderate to severe atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- CM512
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2024to 12 Sep 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
- Body mass index (BMI) ranges from 18.0 to 26.0 kg/m2 (including boundary values).
Who cannot join
- Have participated in any clinical trials of drugs or medical devices within 3 months before the screening.
- Have severe infections, severe injuries, or undergone major surgical procedures within 3 months before screening.
- Have lost more than 400 mL of blood due to blood donation or other reasons within 3 months before screening.
- Positive drug abuse test or positive alcohol breath test result.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Single/Multiple Dose Escalation, Placebo-controlled Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM512 in Healthy Subjects and Patients With Moderate to Severe Atopic Dermatitis
This is a randomized, double-blind, single/multiple dose escalation, placebo-controlled phase I study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in healthy subjects and patients with moderate to severe atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- CM512, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM512Biological
CM512 injection
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Biological: CM512; Drug: Placebo |
| Group 2 | Experimental | Not described Receives: Biological: CM512; Drug: Placebo |
| Group 3 | Experimental | Not described Receives: Biological: CM512; Drug: Placebo |
| Group 4 | Experimental | Not described Receives: Biological: CM512; Drug: Placebo |
| Group 5 | Experimental | Not described Receives: Biological: CM512; Drug: Placebo |
| Group 6 | Experimental | Not described Receives: Biological: CM512; Drug: Placebo |
| Group 7 | Experimental | Not described Receives: Biological: CM512; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Incidence of adverse events.
Measured: Up to 141 days or up to 169 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start2 Sep 2024
- Primary completion26 Aug 2025
- Study completion12 Sep 2025
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 Atopic DermatitisStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jingyi Li, Principal investigator, West China HospitalPing Feng, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553209
- Sponsor's protocol ID
- CM512-100001
- Status last verified
- Sep 2025
- First submitted
- 11 Aug 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng Y, Liu Q, Li M, Xie Y, Men Y, He M, Wang H, Feng X, Zeng M, Zhang L, Chen B, Li J, Feng P. First-in-human, phase 1 study of CM512, a TSLP/IL-13 bispecific antibody, in healthy volunteers: safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity. Front Immunol. 2026 May 28;17:1811041. doi: 10.3389/fimmu.2026.1811041. eCollection 2026.
PubMed 42292382
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single/Multiple Dose Escalation, Placebo-controlled Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM512 in Healthy Subjects and Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06553209
- Acronym / sponsor ID
- CM512-100001
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- 12 Sep 2025 (actual)
- First posted
- 14 Aug 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 is a randomized, double-blind, single/multiple dose escalation, placebo-controlled phase I study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in healthy subjects and patients with moderate to severe atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: CM512, Drug: Placebo |
| Group 2 | Experimental | Biological: CM512, Drug: Placebo |
| Group 3 | Experimental | Biological: CM512, Drug: Placebo |
| Group 4 | Experimental | Biological: CM512, Drug: Placebo |
| Group 5 | Experimental | Biological: CM512, Drug: Placebo |
| Group 6 | Experimental | Biological: CM512, Drug: Placebo |
| Group 7 | Experimental | Biological: CM512, Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
- Body mass index (BMI) ranges from 18.0 to 26.0 kg/m2 (including boundary values).
Key exclusion criteria (4 listed)
- Have participated in any clinical trials of drugs or medical devices within 3 months before the screening.
- Have severe infections, severe injuries, or undergone major surgical procedures within 3 months before screening.
- Have lost more than 400 mL of blood due to blood donation or other reasons within 3 months before screening.
- Positive drug abuse test or positive alcohol breath test result.
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 |
|---|---|---|
| CM512CM512 injection | Biological | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6, Group 7 |
| PlaceboPlacebo | Drug | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6, Group 7 |
Primary outcome
Adverse events
Time frame: Up to 141 days or up to 169 days
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 22 Sep 2025.
- Derived from this study: PubMed 42292382Cheng Y, Liu Q, Li M, Xie Y, Men Y, He M, Wang H, Feng X, Zeng M, Zhang L, Chen B, Li J, Feng P. First-in-human, phase 1 study of CM512, a TSLP/IL-13 bispecific antibody, in healthy volunteers: safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity. Front Immunol. 2026 May 28;17:1811041. doi: 10.3389/fimmu.2026.1811041. eCollection 2026.
- Individual participant dataSharing planned: No
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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.
Jingyi Li principal investigator
West China Hospital
Ping Feng principal investigator
West China 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 CM512 in people with Atopic Dermatitis, 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 4 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 22 Sep 2025. 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?
Adverse events (time frame: Up to 141 days or up to 169 days). 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 NCT06553209, 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 22 Sep 2025.