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NCT Number: NCT07823764

Study of CM583 in Healthy 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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Second Affiliated Hospital Zhejiang University School of Medcine

Hangzhou, Zhejiang, China

Location contact

Bo Jiang

CONTACT

[email protected]

028-88610620

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

CM583

Biological

CM583 injection administered SC(Subcutaneous), once

Placebo

Drug

Placebo injection administered SC, once

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Jia

CONTACT

[email protected]

028-88610620

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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