AsthmaPhase 1NCT04842201
Single Ascending Dose Study of CM326 in Healthy Volunteers
A Phase 1 study testing CM326 in people with Asthma, run by Keymed Biosciences Co.Ltd at 1 site in China.
Trial summary
Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of CM326 in healthy volunteers. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2021to 28 Sep 2021
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- 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
subcutaneous injection
PlaceboDrug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| CM326 | Experimental | subcutaneous injection Receives: Drug: CM326 |
| Placebo | Placebo comparator | subcutaneous injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of CM326 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs
Measured: Day 1 through Day 85
Secondary outcomes (3)
Pharmacokinetics (PK) of CM326
Serum concentrations of CM326 over time
Measured: Day 1 through Day 85
Pharmacodynamics of CM326
Serum total Immunoglobulin E (IgE) and Thymus and activation regulated chemokine (TARC) over time
Measured: Day 1 through Day 85
Immunogenicity
anti-drug antibody (ADA)
Measured: Day 1 through Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start13 Apr 2021
- Primary completion28 Sep 2021
- Study completion28 Sep 2021
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jie Hou, Principal investigator, Peking University Care Luzhong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842201
- Sponsor's protocol ID
- CM326HV001
- Status last verified
- Nov 2021
- First submitted
- 8 Apr 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04842201
- Acronym / sponsor ID
- CM326HV001
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 28 Sep 2021 (actual)
- Study completion
- 28 Sep 2021 (actual)
- First posted
- 13 Apr 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.
Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of CM326 in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CM326 | Experimental | Drug: CM326subcutaneous injection |
| Placebo | Placebo comparator | Drug: Placebosubcutaneous injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (4 listed)
- 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.
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 |
|---|---|---|
| CM326subcutaneous injection | Drug | CM326 |
| Placebosubcutaneous injection | Drug | Placebo |
Primary outcome
Safety of CM326 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs
Time frame: Day 1 through Day 85
3 secondary outcomes
Pharmacokinetics (PK) of CM326
Time frame: Day 1 through Day 85
Pharmacodynamics of CM326
Time frame: Day 1 through Day 85
Immunogenicity
Time frame: Day 1 through Day 85
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 12 Apr 2022.
- 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.
- Individual participant dataSharing planned: No
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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.
Jie Hou principal investigator
Peking University Care Luzhong Hospital
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 4 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 12 Apr 2022. 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?
Safety of CM326 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs (time frame: Day 1 through Day 85). 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 NCT04842201, 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 12 Apr 2022.