Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)Phase 1NCT07900945
Study of Single and Multiple Ascending Doses of CM551 in Healthy Participants
A Phase 1 study testing CM551 in people with Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), run by Keymed Biosciences Co.Ltd at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-parallel controlled phase I study to evaluate the safety and tolerability of single and multiple doses of CM551 in healthy participants Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
- What is being tested?
- CM551
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Sep 2027
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to understand and comply with study-related procedures, voluntarily sign the Informed Consent Form(ICF).
- Male and female participants must be between 18 and 55 years of age, inclusive, at the time of signing the ICF.
- Participants are in good health as assessed by the investigator during the screening period according to the results of medical history, physical examination, vital signs and various examinations, which are normal or abnormal without clinically significant.
- Body mass index (BMI) between 18.0 and 26.0 kg/m², inclusive, with a body weight at least 50 kg.
Who cannot join
- Restricted concomitant medications, recent clinical trial participation, recent major surgery/severe infection/trauma, blood transfusion/blood donation, prohibited vaccinations, or positive screening serology for Hepatitis B Virus, Hepatitis C Virus, syphilis or Human Immunodeficiency Virus.
- Positive drug abuse or alcohol breath test, tobacco or alcohol use exceeding predefined limits, or inability to abstain from tobacco/alcohol before dosing and during hospitalization.
- Planned strenuous exercise during the study, or inadequate contraception / pregnancy / lactation status for female or male participants of reproductive potential.
- Pregnancy.
- Any other condition judged by the investigator to make the participant unsuitable for study enrollment or unable to complete study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Qian Jia, 028-88610620, clinicaltrial@keymedbio.com
Xiaodong Zhu, MD
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Single/Multiple Ascending Doses of CM551 in Healthy Participants
This is a randomized, double-blind, placebo-parallel controlled phase I study to evaluate the safety and tolerability of single and multiple doses of CM551 in healthy participants
- Being tested
- CM551, Placebo
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM551Biological
Participants will receive single subcutaneous doses of CM551 solution in a dose escalation format across 4 sequential SAD cohorts.
PlaceboDrug
Participants will receive single subcutaneous doses of CM551-matching placebo solution in a dose escalation format across 4 sequential SAD cohorts.
CM551Biological
Participants will receive repeated subcutaneous doses of CM551 solution in a dose escalation format across 2 sequential MAD cohorts.
PlaceboDrug
Participants will receive repeated subcutaneous doses of CM551-matching placebo solution in a dose escalation format across 2 sequential MAD cohorts.
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohorts 1~4 Experimental Arm | Experimental | Not described Receives: Biological: CM551 |
| SAD Cohorts 1~4 Placebo Arm | Placebo comparator | Not described Receives: Drug: Placebo |
| MAD Cohorts 5~6 Experimental Arm | Experimental | Not described Receives: Biological: CM551 |
| MAD Cohorts 5~6 Placebo Arm | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
any adverse event (AE)
Measured: through study completion, an average of 1.5 years
Incidence of Treatment-Emergent Adverse Events
physical examination
Measured: through study completion, an average of 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)Studies 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
- 48 participants (estimated)
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
- NCT07900945
- Sponsor's protocol ID
- CM551-100001
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. 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, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Single/Multiple Ascending Doses of CM551 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07900945
- Acronym / sponsor ID
- CM551-100001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 28 Oct 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, double-blind, placebo-parallel controlled phase I study to evaluate the safety and tolerability of single and multiple doses of CM551 in healthy participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SAD Cohorts 1~4 Experimental Arm | Experimental | Biological: CM551 |
| SAD Cohorts 1~4 Placebo Arm | Placebo comparator | Drug: Placebo |
| MAD Cohorts 5~6 Experimental Arm | Experimental | Biological: CM551 |
| MAD Cohorts 5~6 Placebo Arm | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Able to understand and comply with study-related procedures, voluntarily sign the Informed Consent Form(ICF).
- Male and female participants must be between 18 and 55 years of age, inclusive, at the time of signing the ICF.
- Participants are in good health as assessed by the investigator during the screening period according to the results of medical history, physical examination, vital signs and various examinations, which are normal or abnormal without clinically significant.
- Body mass index (BMI) between 18.0 and 26.0 kg/m², inclusive, with a body weight at least 50 kg.
Key exclusion criteria (5 listed)
- Restricted concomitant medications, recent clinical trial participation, recent major surgery/severe infection/trauma, blood transfusion/blood donation, prohibited vaccinations, or positive screening serology for Hepatitis B Virus, Hepatitis C Virus, syphilis or Human Immunodeficiency Virus.
- Positive drug abuse or alcohol breath test, tobacco or alcohol use exceeding predefined limits, or inability to abstain from tobacco/alcohol before dosing and during hospitalization.
- Planned strenuous exercise during the study, or inadequate contraception / pregnancy / lactation status for female or male participants of reproductive potential.
- Pregnancy.
- Any other condition judged by the investigator to make the participant unsuitable for study enrollment or unable to complete study procedures.
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 |
|---|---|---|
| CM551Participants will receive single subcutaneous doses of CM551 solution in a dose escalation format across 4 sequential SAD cohorts. | Biological | SAD Cohorts 1~4 Experimental Arm |
| PlaceboParticipants will receive single subcutaneous doses of CM551-matching placebo solution in a dose escalation format across 4 sequential SAD cohorts. | Drug | SAD Cohorts 1~4 Placebo Arm |
| CM551Participants will receive repeated subcutaneous doses of CM551 solution in a dose escalation format across 2 sequential MAD cohorts. | Biological | MAD Cohorts 5~6 Experimental Arm |
| PlaceboParticipants will receive repeated subcutaneous doses of CM551-matching placebo solution in a dose escalation format across 2 sequential MAD cohorts. | Drug | MAD Cohorts 5~6 Placebo Arm |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: through study completion, an average of 1.5 years
any adverse event (AE)
Incidence of Treatment-Emergent Adverse Events
Time frame: through study completion, an average of 1.5 years
physical examination
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 28 Oct 2026.
Related trials for Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Not yet recruiting
Effects of Different Physical Activity Strategies on Disease Activity of IBD Patients
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
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.
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 CM551 in people with Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), 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 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: opening soon, as of the sponsor's last update on 28 Oct 2026. 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?
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 Qian Jia (028-88610620, clinicaltrial@keymedbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: through study completion, an average of 1.5 years). 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 28 Oct 2026.