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Completed

NCT Number: NCT05371379

Multiple Ascending Dose Study of CM338 in Healthy Volunteers

This study was a multi-center, randomized, double blind, placebo-controlled, single-dose, dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM338 with multiple dosing in healthy subjects.

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Key information

Conditions

Healthy Subjects

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PKUCare Luzhong Hospital

Zibo, China

About this study

The study included screening period, administration and safety follow-up period.

Forty-eight healthy volunteers will be enrolled and randomized into 4 groups.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male volunteers, aged ≥18 and ≤65 years.
  • Medical history, vital signs, physical examination, 12-lead ECG, X-ray, and abdominal color ultrasound results are normal, or abnormal without clinically significance.
  • All clinical laboratory examination are normal, or abnormal without clinical significance.

Exclusion criteria

  • Take any prescription medicine within 2 weeks before administration, or take any Chinese medicine or non-prescription medicine within 1 week.
  • Live attenuated vaccine was administered within 30 days prior to administration or planned to vaccinate during the study period.
  • Major surgery will be planned during the study period, or major surgery was performed within 4 weeks prior to dosing.
  • Any blood loss greater than 400 mL by voluntary blood donation or in any other manner within 4 weeks prior to administration.

Treatment and study plan

CM338 Injection

Biological

A humanized monoclonal antibody.

Primary outcomes

  1. Incidence of Adverse Events (AEs).

    Time frame: Up to Week 12.

    Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

A Multiple-dose, Randomized, Double Blind, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM338 Injection in Healthy Subjects

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 12, 2022
Registry last updated
Oct 15, 2024

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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