Healthy SubjectsPhase 1NCT05371379
Multiple Ascending Dose Study of CM338 in Healthy Volunteers
A Phase 1 study testing CM338 Injection in people with Healthy Subjects, run by Keymed Biosciences Co.Ltd at 1 site in China.
Trial summary
This study was a multi-center, randomized, double blind, placebo-controlled, single-dose, dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM338 with multiple dosing in healthy subjects. 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
- Healthy Subjects
- What is being tested?
- CM338 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2022to 4 Nov 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
- Healthy male volunteers, aged ≥18 and ≤65 years.
- Medical history, vital signs, physical examination, 12-lead ECG, X-ray, and abdominal color ultrasound results are normal, or abnormal without clinically significance.
- All clinical laboratory examination are normal, or abnormal without clinical significance.
Who cannot join
- Take any prescription medicine within 2 weeks before administration, or take any Chinese medicine or non-prescription medicine within 1 week.
- Live attenuated vaccine was administered within 30 days prior to administration or planned to vaccinate during the study period.
- Major surgery will be planned during the study period, or major surgery was performed within 4 weeks prior to dosing.
- Any blood loss greater than 400 mL by voluntary blood donation or in any other manner within 4 weeks prior to administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multiple-dose, Randomized, Double Blind, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM338 Injection in Healthy Subjects
This study was a multi-center, randomized, double blind, placebo-controlled, single-dose, dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM338 with multiple dosing in healthy subjects.
Read the detailed description
The study included screening period, administration and safety follow-up period.
Forty-eight healthy volunteers will be enrolled and randomized into 4 groups.
- Conditions
- Healthy Subjects
- Being tested
- CM338 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM338 InjectionBiological
A humanized monoclonal antibody.
| Study group | Role | What they receive |
|---|---|---|
| CM338 75 mg, subcutaneous injection | Experimental | Qquaque week Receives: Biological: CM338 Injection |
| CM338 150 mg, subcutaneous injection | Experimental | Qquaque week Receives: Biological: CM338 Injection |
| CM338 300 mg, subcutaneous injection | Experimental | Qquaque week Receives: Biological: CM338 Injection |
| CM338 300 mg, intravenous infusion | Experimental | Qquaque week Receives: Biological: CM338 Injection |
| Placebo | Placebo comparator | placebo Receives: Biological: CM338 Injection |
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 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start24 May 2022
- Primary completion4 Nov 2022
- Study completion4 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- 48 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
- NCT05371379
- Sponsor's protocol ID
- CM338-100002
- Status last verified
- Oct 2024
- First submitted
- 7 May 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-dose, Randomized, Double Blind, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM338 Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05371379
- Acronym / sponsor ID
- CM338-100002
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 24 May 2022 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 12 May 2022 (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 study was a multi-center, randomized, double blind, placebo-controlled, single-dose, dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM338 with multiple dosing in healthy subjects.
Detailed description
The study included screening period, administration and safety follow-up period.
Forty-eight healthy volunteers will be enrolled and randomized into 4 groups.
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 |
|---|---|---|
| CM338 75 mg, subcutaneous injection | Experimental | Biological: CM338 InjectionQquaque week |
| CM338 150 mg, subcutaneous injection | Experimental | Biological: CM338 InjectionQquaque week |
| CM338 300 mg, subcutaneous injection | Experimental | Biological: CM338 InjectionQquaque week |
| CM338 300 mg, intravenous infusion | Experimental | Biological: CM338 InjectionQquaque week |
| Placebo | Placebo comparator | Biological: CM338 Injectionplacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male volunteers, aged ≥18 and ≤65 years.
- Medical history, vital signs, physical examination, 12-lead ECG, X-ray, and abdominal color ultrasound results are normal, or abnormal without clinically significance.
- All clinical laboratory examination are normal, or abnormal without clinical significance.
Key exclusion criteria (4 listed)
- Take any prescription medicine within 2 weeks before administration, or take any Chinese medicine or non-prescription medicine within 1 week.
- Live attenuated vaccine was administered within 30 days prior to administration or planned to vaccinate during the study period.
- Major surgery will be planned during the study period, or major surgery was performed within 4 weeks prior to dosing.
- Any blood loss greater than 400 mL by voluntary blood donation or in any other manner within 4 weeks prior to administration.
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 |
|---|---|---|
| CM338 InjectionA humanized monoclonal antibody. | Biological | CM338 150 mg, subcutaneous injection, CM338 300 mg, intravenous infusion, CM338 300 mg, subcutaneous injection, CM338 75 mg, subcutaneous injection, Placebo |
Primary outcome
Incidence of Adverse Events (AEs).
Time frame: Up to Week 12.
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
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 15 Oct 2024.
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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 CM338 Injection in people with Healthy Subjects, 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 3 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 15 Oct 2024. 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 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.