Study of CM583 in Healthy Participants

NCT07823764 | Not Yet Recruiting Phase 1

• 1 other identifier: CM583-100001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Healthy

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Day 1 up to Day 169 or early discontinuation

Study Arms (5)

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

Interventions

CM583 BIOLOGICAL

CM583 injection administered SC(Subcutaneous), once

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

Placebo DRUG

Placebo injection administered SC, once

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keymed Biosciences Co.Ltd: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medcine

Hangzhou, Zhejiang, China

Location

Central Study Contacts

Qian Jia

CONTACT

028-88610620; clinicaltrial@keymedbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 16, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09

Locations

CN (1)