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Completed

NCT Number: NCT05186285

Single Ascending Dose Study of CM338 in Healthy Volunteers

This study was a single-center, randomized, double blind, placebo-controlled, single-dose, dose-increasing study to evaluate the safety, tolerability, PK characteristics, PD effect, and immunogenicity of CM338 injection administered intravenously or subcutaneously at different doses in healthy subjects.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PKUCare Luzhong Hospital

Zibo, Shandong, China

About this study

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

Sixty-six healthy volunteers will be enrolled and randomized into 8 groups.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • with the ability to understand this study and voluntarily sign the informed consent form.
  • 18 to 65 years of age.
  • with normal or abnormal without clinically significance on medical history, vital signs, physical examination, 12-lead ECG, laboratory examination, chest X-ray, and abdominal color ultrasound, etc.
  • able to communicate with the researchers and follow the requirements specified in the protocol.
  • agree to use effective contraceptive methods from signing the ICF to 6 months after the administration.

Exclusion criteria

  • plan to conduct any major surgery during the study.
  • known allergy to monoclonal antibody drugs or other related drugs, or to the excipients of CM338 injection.
  • with any clinical history including serious diseases or circulatory system, endocrine system, nervous system, blood system, immune system, mental system and metabolic abnormalities.

Treatment and study plan

CM338

Drug

CM338 : a humanized monoclonal antibody.

Placebo

Drug

Placebo.

Primary outcomes

  1. Safety : Incidence of Adverse Events (AEs).

    Time frame: Baseline up to Day 57

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

Secondary outcomes

  1. Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)

    Time frame: Baseline up to Day 57

    Peak Plasma concentration (Cmax)

  2. Pharmacokinetics (PK) parameter : Time to reach peak concentration (Tmax)

    Time frame: Baseline up to Day 57

    Time to reach peak concentration (Tmax)

  3. Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)

    Time frame: Baseline up to Day 57

    Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)

  4. Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve from 0 to t (AUC0-t)

    Time frame: Baseline up to Day 57

    Area under the plasma concentration-time curve from 0 to t (AUC0-t)

  5. Pharmacokinetics (PK) parameter : Clearance rate (CL/F)

    Time frame: Baseline up to Day 57

    Clearance rate (CL/F)

  6. Bioavailability : bioavailability of CM338 with SC

    Time frame: Baseline up to Day 57

    The bioavailability of CM338 with SC

  7. Pharmacodynamics (PD) : C4b deposition activity of mannose-binding lectin serine protease 2 (MASP-2) in serum.

    Time frame: Baseline up to Day 57

    C4b deposition activity of mannose-binding lectin serine protease 2 (MASP-2) in serum.

  8. Pharmacodynamics (PD) : the content of mannose-binding lectin serine protease 2 (MASP-2) in serum.

    Time frame: Baseline up to Day 57

    The content of mannose-binding lectin serine protease 2 (MASP-2) in serum.

  9. Immunogenicity: Proportion of subjects with anti-drug antibody (ADA).

    Time frame: Baseline up to Day 57

    Proportion of subjects with anti-drug antibody (ADA).

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

A Single-dose, Randomized, Double Blind, Placebo-controlled, Dose-increasing Study to Evaluate the Safety, Tolerability, PK Characteristics, PD Effect, and Immunogenicity of CM338 Injection in Healthy Subjects.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 11, 2022
Registry last updated
Nov 8, 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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