Not yet recruitingNCT07823764Updated Sep 16, 2026

Study of CM583 in Healthy Participants

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

Phase: Phase 1
Study type: Interventional
Enrollment: 40
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: All

Study 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. Within each cohort, participants will be randomized in a 3:1 ratio to receive a single subcutaneous dose of CM583 or placebo.

Conditions studied

Healthy

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Subjects age ≥ 18 years \& ≤45 years.
Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 40 participants (estimated)

Study arms

Experimental
CM583 or matched placebo cohort 1
Biological: CM583 · Drug: Placebo
Experimental
CM583 or matched placebo cohort 2
Biological: CM583 · Drug: Placebo
Experimental
CM583 or matched placebo cohort 3
Biological: CM583 · Drug: Placebo
Experimental
CM583 or matched placebo cohort 4
Biological: CM583 · Drug: Placebo
Experimental
CM583 or matched placebo cohort 5
Biological: CM583 · Drug: Placebo

Interventions

BiologicalCM583
CM583 injection administered SC(Subcutaneous), once
DrugPlacebo
Placebo injection administered SC, once

What researchers measure

Primary outcomes

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

Study locations

1 site

The Second Affiliated Hospital Zhejiang University School of Medcine
Hangzhou, Zhejiang, China
- Bo Jiang · Contact · clinicaltrial@keymedbio.com · 028-88610620

Registry details

Key details

Study ID: NCT07823764
Lead sponsor: Keymed Biosciences Co.Ltd
Responsible party: Sponsor
First posted: Sep 16, 2026
Start date: Oct 2026 (estimated)
Primary completion: Jul 2027 (estimated)
Completion: Jul 2027 (estimated)
Last update: Sep 16, 2026

Study contacts

Qian Jia

Contact

clinicaltrial@keymedbio.com

028-88610620

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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