Health TrialsbyHealthPanel

Study of CM583 in Healthy Participants

ConditionHealthy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorKeymed Biosciences Co.Ltd

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Subjects age ≥ 18 years & ≤45 years.

Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • CM583

    Biological/Vaccine

    CM583 injection administered SC(Subcutaneous), once

  • Placebo

    Drug

    Placebo injection administered SC, once

Treatment groups

40 Participants
are divided into 5 treatment groups
Group A: CM583 or matched placebo cohort 1Experimental treatment 2 interventions
Group B: CM583 or matched placebo cohort 2Experimental treatment 2 interventions
Group C: CM583 or matched placebo cohort 3Experimental treatment 2 interventions
Group D: CM583 or matched placebo cohort 4Experimental treatment 2 interventions
Group E: CM583 or matched placebo cohort 5Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Keymed Biosciences Co.Ltd

Lead sponsor

Source ClinicalTrials.gov

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