HealthyPhase 1NCT07823764
Study of CM583 in Healthy Participants
A Phase 1 study testing CM583 in people with Healthy, run by Keymed Biosciences Co.Ltd at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CM583
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Jul 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects age ≥ 18 years \& ≤45 years.
- Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.
Who cannot join
- The average number of cigarettes smoked per day is greater than 5 within 3 months prior to screening.
- Drinking heavily within 3 months prior to screening, or unable to guarantee not to drink alcohol during the research period, or positive alcohol breath testing.
- History of drug abuse within 1 year prior to screening, or positive urine drug abuse screening.
- Blood donation or any other form of blood loss exceeding 400mL, or accepting blood transfusion within 12 weeks prior to screening.
- Suspected allergy to CGRP(Calcitonin Gene-Related Peptide)- or PACAP(Pituitary Adenylate Cyclase-Activating Polypeptide)-targeting antibody drugs, humanized monoclonal antibody drugs and their excipients, or other biological agents, or have a history of severe allergic reactions to other drugs.
- Severe trauma or undergo major surgery within 3 months prior to screening, or planned surgery during the research period.
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
The Second Affiliated Hospital Zhejiang University School of Medcine
Hangzhou, Zhejiang
Bo Jiang, 028-88610620, clinicaltrial@keymedbio.com
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single Ascending Doses of CM583 in Healthy Adult Participants
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.
- Conditions
- Healthy
- Being tested
- CM583, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM583Biological
CM583 injection administered SC(Subcutaneous), once
PlaceboDrug
Placebo injection administered SC, once
| Study group | Role | What they receive |
|---|---|---|
| CM583 or matched placebo cohort 1 | Experimental | Not described Receives: Biological: CM583; Drug: Placebo |
| CM583 or matched placebo cohort 2 | Experimental | Not described Receives: Biological: CM583; Drug: Placebo |
| CM583 or matched placebo cohort 3 | Experimental | Not described Receives: Biological: CM583; Drug: Placebo |
| CM583 or matched placebo cohort 4 | Experimental | Not described Receives: Biological: CM583; Drug: Placebo |
| CM583 or matched placebo cohort 5 | Experimental | Not described Receives: Biological: CM583; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 up to Day 169 or early discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 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
- NCT07823764
- Sponsor's protocol ID
- CM583-100001
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 16 Sep 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single Ascending Doses of CM583 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07823764
- Acronym / sponsor ID
- CM583-100001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 16 Sep 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-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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CM583 or matched placebo cohort 1 | Experimental | Biological: CM583, Drug: Placebo |
| CM583 or matched placebo cohort 2 | Experimental | Biological: CM583, Drug: Placebo |
| CM583 or matched placebo cohort 3 | Experimental | Biological: CM583, Drug: Placebo |
| CM583 or matched placebo cohort 4 | Experimental | Biological: CM583, Drug: Placebo |
| CM583 or matched placebo cohort 5 | Experimental | Biological: CM583, Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects age ≥ 18 years \& ≤45 years.
- Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.
Key exclusion criteria (6 listed)
- The average number of cigarettes smoked per day is greater than 5 within 3 months prior to screening.
- Drinking heavily within 3 months prior to screening, or unable to guarantee not to drink alcohol during the research period, or positive alcohol breath testing.
- History of drug abuse within 1 year prior to screening, or positive urine drug abuse screening.
- Blood donation or any other form of blood loss exceeding 400mL, or accepting blood transfusion within 12 weeks prior to screening.
- Suspected allergy to CGRP(Calcitonin Gene-Related Peptide)- or PACAP(Pituitary Adenylate Cyclase-Activating Polypeptide)-targeting antibody drugs, humanized monoclonal antibody drugs and their excipients, or other biological agents, or have a history of severe allergic reactions to other drugs.
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 |
|---|---|---|
| CM583CM583 injection administered SC(Subcutaneous), once | Biological | CM583 or matched placebo cohort 1, CM583 or matched placebo cohort 2, CM583 or matched placebo cohort 3, CM583 or matched placebo cohort 4, CM583 or matched placebo cohort 5 |
| PlaceboPlacebo injection administered SC, once | Drug | CM583 or matched placebo cohort 1, CM583 or matched placebo cohort 2, CM583 or matched placebo cohort 3, CM583 or matched placebo cohort 4, CM583 or matched placebo cohort 5 |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day 1 up to Day 169 or early discontinuation
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.
Number of Participants With Clinically Significant Physical Examination Abnormalities
Time frame: Day 1 up to Day 169 or early discontinuation
Physical examination findings judged to be clinically significant by the investigator will be summarized.
Number of Participants With Clinically Significant Vital Sign Abnormalities
Time frame: Day 1 up to Day 169 or early discontinuation
Vital sign assessments include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Clinically significant postbaseline abnormalities will be summarized.
Change From Baseline in Heart Rate, PR Interval, QRS Duration, QT Interval, QTcF Measured by 12-Lead Electrocardiogram
Time frame: Day 1 up to Day 169 or early discontinuation
Heart Rate, PR Interval, QRS Duration, QT Interval, QTcF (calculated as QT/RR^0.33) will be measured using a 12-lead electrocardiogram.
Number of Participants With Clinically Significant Laboratory Test Abnormalities
Time frame: Day 1 up to Day 169 or early discontinuation
Laboratory assessments include hematology, blood chemistry, coagulation, lipid tests, and urinalysis. Clinically significant postbaseline abnormalities will be summarized.
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 16 Sep 2026.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 CM583 in people with Healthy, 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 6 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 16 Sep 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. 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?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Day 1 up to Day 169 or early discontinuation). The study lists 5 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 16 Sep 2026.