ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Early-phase safety testing is the first step toward developing new IBD treatments; people tracking future therapies may want to note that CM551 has entered a first-in-human trial. This trial enrolls healthy volunteers, so it will only address safety/tolerability, not whether the drug helps IBD yet.
Who Should Pay Attention
Researchers, clinicians, and patients/advocates who follow investigational IBD therapies and drug development progress.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 1
Enrollment48 participants
Study statusNot_yet_recruiting
Source depthTrial registry record
What To Know
This is a ClinicalTrials.gov record for a Phase 1, randomized, double-blind, placebo-controlled study of CM551 given as single ascending subcutaneous doses (SAD) and multiple ascending subcutaneous doses (MAD) in healthy adult participants.
The trial is not yet recruiting and plans to enroll about 48 participants in China; primary outcomes are safety and incidence of treatment-emergent adverse events through study completion.
The study is targeted at inflammatory bowel disease (Crohn’s disease and ulcerative colitis) as the intended conditions but the current trial enrolls healthy volunteers to assess safety and tolerability before patient studies. Participants will receive CM551 or matching placebo across sequential dose-escalation cohorts.
If you follow IBD drug development, this is an early first-in-human safety study for an investigational therapy (CM551). It does not report results and does not imply clinical benefit; it is primarily designed to characterize safety and tolerability.
Keep In Mind
Phase 1 trials in healthy volunteers focus on safety and dose escalation; they do not provide evidence of benefit in patients. The record lists no results; the study status is not yet recruiting.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorKeymed Biosciences Co.Ltd
Trial IDNCT07900945
Study typeInterventional
Trial phasePhase 1
Enrollment48 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedOct 28, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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