CompletedNCT05171348Updated Jun 22, 2023

A Multiple Ascending Doses Study of CM326 Injection in Healthy Subjects

A Phase 1 interventional study of CM326 and Placebo in Asthma, sponsored by Keymed Biosciences Co.Ltd. Completed at 1 site in China. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-22.

Sponsored by Keymed Biosciences Co.Ltd · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 40
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: Male

Study 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.

Conditions studied

Asthma

In context

Lead sponsor

Keymed Biosciences Co.Ltd is the lead sponsor of 63 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: Male
Accepts 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

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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 40 participants (actual)

Study arms

Experimental
CM326 55mg Q2W
55mg for 6 doses, SC, Q2W
Drug: CM326
Experimental
CM326 110mg Q2W
110mg for 6 doses, SC, Q2W
Drug: CM326
Experimental
CM326 220mg Q2W
220mg for 6 doses, SC, Q2W
Drug: CM326
Experimental
CM326 220mg Q4W
220mg for 3 doses, SC, Q4W
Drug: CM326
Placebo comparator
Placebo
Placebo
Drug: Placebo

Interventions

DrugCM326
a humanized monoclonal antibody
DrugPlacebo
Placebo

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

West China Hospital of Sichuan University
Chengdu, Sichuan, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05171348
Lead sponsor: Keymed Biosciences Co.Ltd
Responsible party: Sponsor
First posted: Dec 28, 2021
Start date: Jan 7, 2022
Primary completion: Oct 11, 2022
Completion: Oct 11, 2022
Last update: Jun 22, 2023

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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