NCT05171348

Brief Summary

This is a single-center, randomized, double-blind, placebo-controlled, dose-escalating study to evaluate the safety, tolerability, PK profile, and immunogenicity of multiple SC administraion of CM326 at different doses in healthy subjects. 40 healthy male subjects will be enrolled in the study. The drug will be administered by dose-escalating principle at 4 dose levels: 55 mg Q2W, 110 mg Q2W, 220 mg Q2W, 220 mg Q4W.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 asthma

Timeline
Completed

Started Jan 2022

Typical duration for phase_1 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 28, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

January 7, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2022

Completed
Last Updated

June 22, 2023

Status Verified

December 1, 2021

Enrollment Period

9 months

First QC Date

December 9, 2021

Last Update Submit

June 20, 2023

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events (AEs)

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

    up to Week 24

Secondary Outcomes (5)

  • PK parameters: time to maximum concentration (Tmax).

    up to Week 16

  • PK parameters: maximum concentration (Cmax).

    up to Week 16

  • PK parameters: area under the plasma concentration-time curve over a dosing interval (AUCtau).

    up to Week 16

  • PK parameters: area under the plasma concentration-time curve from 0 to t (AUC0-t).

    up to Week 16

  • Immunogenicity endpoints: Occurrence of anti-drug antibodies (ADA) to CM326.

    up to Week 16

Study Arms (5)

CM326 55mg Q2W

EXPERIMENTAL

55mg for 6 doses, SC, Q2W

Drug: CM326

CM326 110mg Q2W

EXPERIMENTAL

110mg for 6 doses, SC, Q2W

Drug: CM326

CM326 220mg Q2W

EXPERIMENTAL

220mg for 6 doses, SC, Q2W

Drug: CM326

CM326 220mg Q4W

EXPERIMENTAL

220mg for 3 doses, SC, Q4W

Drug: CM326

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

CM326DRUG

a humanized monoclonal antibody

CM326 110mg Q2WCM326 220mg Q2WCM326 220mg Q4WCM326 55mg Q2W
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male healthy volunteers, aged between 18 and 65 years of age inclusive, with a body mass index (BMI) within 18-26 kg/m2 (inclusive);
  • Medical history, vital signs, physical examination, 12-lead Electrocardiogram, chest X-ray and abdominal color ultrasound are normal or abnormal with no clinical significance;
  • All variables of clinical laboratory tests are normal or abnormal with no clinical significance;
  • Subjects and partners agree to take effective contraception throughout the study (from screening to 3 months after the end of treatment);
  • Capable of understanding the nature of the study and voluntarily signing the Informed Consent Form.

You may not qualify if:

  • Known allergy to monoclonal antibody drugs or other related drugs, or allergy to excipients of CM326 injection;
  • History of any clinically serious disease or history of circulatory, endocrine, neurological or hematological, immune, psychiatric, and metabolic diseases;
  • History of asthma and allergic reactions;
  • Use of any prescription drugs within 2 weeks prior to dosing, use of traditional Chinese medicine or over-the-counter drugs within 1 week prior to dosing;
  • Received any marketed or investigational biologics within 5 half-lives (if known) or 12 weeks (whichever is longer) prior to dosing, or any investigational non-biologics within 5 half-lives (if known) or 4 weeks (whichever is longer) prior to dosing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

Related Publications (1)

  • Di Y, Yang L, Zhou J, Zhang L, Huang Y, Jia Y, Yan H, Chen L, Hou Q, Chen B, Luo Z, Hou J. Translational Investigation of CM326 from Preclinical Studies to Randomized Phase I Clinical Trials in Healthy Adults. BioDrugs. 2025 May;39(3):487-498. doi: 10.1007/s40259-025-00714-4. Epub 2025 Apr 4.

    PMID: 40185989DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2021

First Posted

December 28, 2021

Study Start

January 7, 2022

Primary Completion

October 11, 2022

Study Completion

October 11, 2022

Last Updated

June 22, 2023

Record last verified: 2021-12

Locations

CN(1)