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Study of CM326 Injection in Healthy Subjects

Recruiting
18 - 65 years of age
Male
Phase 1

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Overview

This study is a single-center, randomized, double-blind, placebo-controlled, dose-increasing phase I clinical study.

Description

The purpose of this study is to evaluate the safety, tolerance, pharmacokinetics and immunogenicity of single and multiple subcutaneous administration of CM326 at different doses in healthy male subjects.

Eligibility

Inclusion Criteria:

  • Age ≥18 years and ≤ 65 years, healthy male.
  • With normal or abnormal laboratory test results without clinical significanceat screening period and baseline.
  • Subjects can communicate well with investigators and comply with protocol requirements.

Exclusion Criteria:

  • Any live attenuated vaccine is planned to be inoculated 30 days before administration or during the study period.
  • Major surgery is planned during the study period.
  • The average daily smoking volume is more than 5 cigarettes within 3 months before screening.
  • Within 12 weeks before administration, blood loss from voluntary blood donation or any attempt to visit is greater than 400 mL.
  • There are any reasons that the investigator believes will prevent the subject from participating in the study.

Study details

Healthy

NCT05715333

Keymed Biosciences Co.Ltd

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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