A Multiple Ascending Doses Study of CM326 Injection in Healthy Subjects

A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Multiple Ascending Doses of CM326 Injection by Subcutaneous Administration in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05171348

Enrollment

Registered

2021-12-28

Start date

2022-01-07

Completion date

2022-10-11

Last updated

2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

DRUGCM326

a humanized monoclonal antibody

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of adverse events (AEs)	up to Week 24	Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

Secondary

Measure	Time frame	Description
PK parameters: time to maximum concentration (Tmax).	up to Week 16	Time to maximum concentration (Tmax).
PK parameters: maximum concentration (Cmax).	up to Week 16	Maximum concentration (Cmax).
PK parameters: area under the plasma concentration-time curve over a dosing interval (AUCtau).	up to Week 16	Area under the plasma concentration-time curve over a dosing interval (AUCtau).
PK parameters: area under the plasma concentration-time curve from 0 to t (AUC0-t).	up to Week 16	Area under the plasma concentration-time curve from 0 to t (AUC0-t).
Immunogenicity endpoints: Occurrence of anti-drug antibodies (ADA) to CM326.	up to Week 16	Occurrence of anti-drug antibodies (ADA) to CM326.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026