AsthmaPhase 1NCT05171348
A Multiple Ascending Doses Study of CM326 Injection in Healthy Subjects
A Phase 1 study testing CM326 in people with Asthma, run by Keymed Biosciences Co.Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- CM326
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2022to 11 Oct 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Asthma
- Being tested
- CM326, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM326Drug
a humanized monoclonal antibody
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| CM326 55mg Q2W | Experimental | 55mg for 6 doses, SC, Q2W Receives: Drug: CM326 |
| CM326 110mg Q2W | Experimental | 110mg for 6 doses, SC, Q2W Receives: Drug: CM326 |
| CM326 220mg Q2W | Experimental | 220mg for 6 doses, SC, Q2W Receives: Drug: CM326 |
| CM326 220mg Q4W | Experimental | 220mg for 3 doses, SC, Q4W Receives: Drug: CM326 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Measured: up to Week 24
Secondary outcomes (5)
PK parameters: time to maximum concentration (Tmax).
Time to maximum concentration (Tmax).
Measured: up to Week 16
PK parameters: maximum concentration (Cmax).
Maximum concentration (Cmax).
Measured: 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).
Measured: 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).
Measured: up to Week 16
Immunogenicity endpoints: Occurrence of anti-drug antibodies (ADA) to CM326.
Occurrence of anti-drug antibodies (ADA) to CM326.
Measured: up to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start7 Jan 2022
- Primary completion11 Oct 2022
- Study completion11 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Keymed Biosciences Co.LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171348
- Sponsor's protocol ID
- CM326HV002
- Status last verified
- Dec 2021
- First submitted
- 9 Dec 2021
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40185989
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05171348
- Acronym / sponsor ID
- CM326HV002
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 11 Oct 2022 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 28 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CM326 55mg Q2W | Experimental | Drug: CM32655mg for 6 doses, SC, Q2W |
| CM326 110mg Q2W | Experimental | Drug: CM326110mg for 6 doses, SC, Q2W |
| CM326 220mg Q2W | Experimental | Drug: CM326220mg for 6 doses, SC, Q2W |
| CM326 220mg Q4W | Experimental | Drug: CM326220mg for 3 doses, SC, Q4W |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CM326a humanized monoclonal antibody | Drug | CM326 110mg Q2W, CM326 220mg Q2W, CM326 220mg Q4W, CM326 55mg Q2W |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Incidence of adverse events (AEs)
Time frame: up to Week 24
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
5 secondary outcomes
PK parameters: time to maximum concentration (Tmax).
Time frame: up to Week 16
PK parameters: maximum concentration (Cmax).
Time frame: up to Week 16
PK parameters: 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).
Time frame: up to Week 16
Immunogenicity endpoints: Occurrence of anti-drug antibodies (ADA) to CM326.
Time frame: up to Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Derived from this study: PubMed 40185989Di 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CM326 in people with Asthma, run by Keymed Biosciences Co.Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (time frame: up to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05171348, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.