NCT07900945Not yet recruitingPhase 1
Study of Single and Multiple Ascending Doses of CM551 in Healthy Participants
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
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 22 Oct 2026
- Start date
- Oct 2026
- Primary completion date
- Sept 2027
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07900945
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 48
- From Oct 2026 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Any other condition judged by the investigator to make the participant unsuitable for study enrollment or unable to complete study procedures.
Other
- Planned strenuous exercise during the study, or inadequate contraception / pregnancy / lactation status for female or male participants of reproductive potential.
- Pregnancy.
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.