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Completed

NCT Number: NCT04842201

Single Ascending Dose Study of CM326 in Healthy Volunteers

Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of CM326 in healthy volunteers.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PKUCare Luzhong Hospital

Zibo, Shandong, China

Who can participate

Healthy volunteers accepted: Yes

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

Key Inclusion Criteria:

  • Healthy adult male participant,18 to 65 years of age, inclusive.
  • Body Mass Index (BMI) 18 to 26 kg/m2, inclusive.
  • History, physical examination, laboratory tests and test related items of inspection were normal or abnormal without clinically insignificant.
  • Males must abstain from sex or use highly effective methods of birth control.
  • Having given written informed consent prior to undertaking any study-related procedure.

Key Exclusion Criteria:

  • Positive for HIV, or Hepatitis B, or C.
  • Positive result on urine drug screen.
  • Clinical laboratory abnormalities of clinical significance, or other clinical findings suggest clinically significant following diseases (including, but not limited to the gastrointestinal tract, kidney, liver, nerve, blood, endocrine, cancer, lung, immune, mental or cardiovascular disease).
  • With any condition that inappropriate for entry into this study.

Treatment and study plan

CM326

Drug

subcutaneous injection

Placebo

Drug

subcutaneous injection

Primary outcomes

  1. Safety of CM326 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs

    Time frame: Day 1 through Day 85

Secondary outcomes

  1. Pharmacokinetics (PK) of CM326

    Time frame: Day 1 through Day 85

    Serum concentrations of CM326 over time

  2. Pharmacodynamics of CM326

    Time frame: Day 1 through Day 85

    Serum total Immunoglobulin E (IgE) and Thymus and activation regulated chemokine (TARC) over time

  3. Immunogenicity

    Time frame: Day 1 through Day 85

    anti-drug antibody (ADA)

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

A Phase 1, Randomized, Placebo-Controlled, Double-blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CM326 in Adult Healthy Volunteers

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 13, 2021
Registry last updated
Apr 12, 2022

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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