Alzheimer DiseasePhase 1NCT06412185
Single Dose Escalation Study of CM383 in Healthy Volunteers
A Phase 1 study testing CM383 in people with Alzheimer Disease, run by Keymed Biosciences Co.Ltd at 1 site in China.
Trial summary
This study is a single center, randomized, double-blind, placebo-controlled Phase I clinical study in a single dose escalation to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM383 in male healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- CM383
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 28 May 2024to 30 Jun 2025
- 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 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males, voluntarily participate;
- 18 and 80 years old (including boundary values);
- able to communicate well with the researchers and follow up the protocol requirements.
Who cannot join
- The average daily smoking volume within three months before screening is greater than 5 cigarettes;
- Excessive alcohol consumption within three months before screening, or positive alcohol breath test;
- Urine drug abuse screening is positive;
- Having a family planning or sperm donation plan; Disagree to adopt efficient contraceptive measures.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jinan Central Hospital
Jinan, Shandong
Qing Wen
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single Dose Escalation of CM383 in Male Healthy Subjects
This study is a single center, randomized, double-blind, placebo-controlled Phase I clinical study in a single dose escalation to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM383 in male healthy subjects.
Read the detailed description
Alzheimer's disease (AD) is the most common type of dementia, which is a degenerative disease of the central nervous system with insidious onset and progressive development. Its clinical features mainly include memory impairment, cognitive impairment, psychobehavioral abnormalities, and social decline.
- Conditions
- Alzheimer Disease
- Being tested
- CM383, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM383Biological
CM383 Injection
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | CM383 injection and matched placebo, intravenous injection Receives: Biological: CM383; Other: Placebo |
| Group 2 | Experimental | CM383 injection and matched placebo, intravenous injection Receives: Biological: CM383; Other: Placebo |
| Group 3 | Experimental | CM383 injection and matched placebo, intravenous injection Receives: Biological: CM383; Other: Placebo |
| Group 4 | Experimental | CM383 injection and matched placebo, intravenous injection Receives: Biological: CM383; Other: Placebo |
| Group 5 | Experimental | CM383 injection and matched placebo, intravenous injection Receives: Biological: CM383; Other: Placebo |
| Group 6 | Experimental | CM383 injection and matched placebo, intravenous injection Receives: Biological: CM383; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Incidence of adverse events.
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 posted14 May 2024
- Study start28 May 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qing Wen, Principal investigator, Jinan Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412185
- Sponsor's protocol ID
- CM383-100001
- Status last verified
- May 2024
- First submitted
- 9 May 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. 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 Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single Dose Escalation of CM383 in Male Healthy Subjects
- ClinicalTrials.gov ID
- NCT06412185
- Acronym / sponsor ID
- CM383-100001
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 28 May 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 14 May 2024 (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 is a single center, randomized, double-blind, placebo-controlled Phase I clinical study in a single dose escalation to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM383 in male healthy subjects.
Detailed description
Alzheimer's disease (AD) is the most common type of dementia, which is a degenerative disease of the central nervous system with insidious onset and progressive development. Its clinical features mainly include memory impairment, cognitive impairment, psychobehavioral abnormalities, and social decline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: CM383, Other: PlaceboCM383 injection and matched placebo, intravenous injection |
| Group 2 | Experimental | Biological: CM383, Other: PlaceboCM383 injection and matched placebo, intravenous injection |
| Group 3 | Experimental | Biological: CM383, Other: PlaceboCM383 injection and matched placebo, intravenous injection |
| Group 4 | Experimental | Biological: CM383, Other: PlaceboCM383 injection and matched placebo, intravenous injection |
| Group 5 | Experimental | Biological: CM383, Other: PlaceboCM383 injection and matched placebo, intravenous injection |
| Group 6 | Experimental | Biological: CM383, Other: PlaceboCM383 injection and matched placebo, intravenous injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy males, voluntarily participate;
- 18 and 80 years old (including boundary values);
- able to communicate well with the researchers and follow up the protocol requirements.
Key exclusion criteria (4 listed)
- The average daily smoking volume within three months before screening is greater than 5 cigarettes;
- Excessive alcohol consumption within three months before screening, or positive alcohol breath test;
- Urine drug abuse screening is positive;
- Having a family planning or sperm donation plan; Disagree to adopt efficient contraceptive measures.
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 |
|---|---|---|
| CM383CM383 Injection | Biological | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| PlaceboPlacebo | Other | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
Primary outcome
Adverse events
Time frame: Up to week 12
Incidence of adverse events.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 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.
Qing Wen principal investigator
Jinan Central 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 CM383 in people with Alzheimer Disease, 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: status not confirmed, as of the sponsor's last update on 8 Nov 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qian Jia (028-88610620, qianjia@keymedbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (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 8 Nov 2024.