A Phase 1 interventional study of CM583 and Placebo in Healthy, sponsored by Keymed Biosciences Co.Ltd. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Keymed Biosciences Co.Ltd · Phase 1, Interventional, and Treatment
This is a randomized, double-blind, placebo-controlled, single-ascending-dose Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM583 in healthy adult participants. Approximately 40 participants will be enrolled in five dose cohorts. Within each cohort, participants will be randomized in a 3:1 ratio to receive a single subcutaneous dose of CM583 or placebo.
Keymed Biosciences Co.Ltd is the lead sponsor of 68 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: CM583 · Drug: Placebo
Biological: CM583 · Drug: Placebo
Biological: CM583 · Drug: Placebo
Biological: CM583 · Drug: Placebo
Biological: CM583 · Drug: Placebo
CM583 injection administered SC(Subcutaneous), once
Placebo injection administered SC, once
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs will be coded using Medical Dictionary for Regulatory Activities(MedDRA) and summarized by System Organ Class and Preferred Term. Serious, severe, treatment-related, fatal TEAEs and TEAEs leading to study withdrawal will also be summarized.
Time frame: Day 1 up to Day 169 or early discontinuation
Number of Participants With Clinically Significant Physical Examination Abnormalities
Physical examination findings judged to be clinically significant by the investigator will be summarized.
Time frame: Day 1 up to Day 169 or early discontinuation
Number of Participants With Clinically Significant Vital Sign Abnormalities
Vital sign assessments include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Clinically significant postbaseline abnormalities will be summarized.
Time frame: Day 1 up to Day 169 or early discontinuation
Change From Baseline in Heart Rate, PR Interval, QRS Duration, QT Interval, QTcF Measured by 12-Lead Electrocardiogram
Heart Rate, PR Interval, QRS Duration, QT Interval, QTcF (calculated as QT/RR\^0.33) will be measured using a 12-lead electrocardiogram.
Time frame: Day 1 up to Day 169 or early discontinuation
Number of Participants With Clinically Significant Laboratory Test Abnormalities
Laboratory assessments include hematology, blood chemistry, coagulation, lipid tests, and urinalysis. Clinically significant postbaseline abnormalities will be summarized.
Time frame: Day 1 up to Day 169 or early discontinuation
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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