Single Ascending Dose Study of CM326 in Healthy Volunteers

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

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: CM326

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Zibo, Shandong, China
      • PKUCare Luzhong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CM326; subcutaneous injection	Drug: CM326; subcutaneous injection
PLACEBO_COMPARATOR: Placebo; subcutaneous injection	Drug: Placebo; subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety of CM326 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs	Day 1 through Day 85

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK) of CM326	Serum concentrations of CM326 over time	Day 1 through Day 85
Pharmacodynamics of CM326	Serum total Immunoglobulin E (IgE) and Thymus and activation regulated chemokine (TARC) over time	Day 1 through Day 85
Immunogenicity	anti-drug antibody (ADA)	Day 1 through Day 85

Collaborators and Investigators

• Sponsor: Keymed Biosciences Co.Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 13, 2021
• Primary Completion (ACTUAL): September 28, 2021
• Study Completion (ACTUAL): September 28, 2021

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (ACTUAL): April 13, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CM326HV001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No