Healthy
Conditions
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.
Interventions
BIOLOGICALCM583
CM583 injection administered SC(Subcutaneous), once
DRUGPlacebo
Placebo injection administered SC, once
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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 | 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 | 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 | 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 | 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. |
Countries
China
Contacts
CONTACTQian Jia
Outcome results
None listed