Alzheimer DiseasePhase 1NCT06619613
A Study of CM383 in Patients With Alzheimer's Disease Related Mild Cognitive Impairment and Mild Alzheimer's Disease
A Phase 1 study testing Alzheimer Disease (AD) in people with Alzheimer Disease, run by Keymed Biosciences Co.Ltd at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled and multiple dose escalation phase Ib study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM383 in patients with Alzheimer's disease related mild cognitive impairment and mild Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Alzheimer Disease (AD)
- 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
- 8 Nov 2024to 30 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate and have the subject and their legal guardian jointly sign the Informed Consent Form.
- The age of the subjects is between 50 and 85 years old.
- BMI≥19kg/m2 and ≤32.5 kg/m2, weight ≥45 kg and ≤100 kg at screening or baseline.
Who cannot join
- Cognitive impairment of subjects due to other medical or neurological factors (other than AD)
- History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past year
- With any mental illness that may interfere with the cognitive assessment of the subjects.
- With history of moderate or severe renal dysfunction.
- With Uncontrolled stable hypertension.
- With history of severe trauma or major surgery in the 6 months prior to the screening period, or planned surgery during the study.
- History of malignancy within 5 years prior to screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei
Jiong Shi
About this study
Official title: A Randomized, Double-blind, Placebo-controlled and Multiple Dose Escalation Phase Ib Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM383 in Patients With Alzheimer's Disease Related Mild Cognitive Impairment and Mild Alzheimer's Disease
This is a randomized, double-blind, placebo-controlled and multiple dose escalation phase Ib study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM383 in patients with Alzheimer's disease related mild cognitive impairment and mild Alzheimer's disease.
- Conditions
- Alzheimer Disease
- Being tested
- Alzheimer Disease (AD), 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.
Alzheimer Disease (AD)Biological
CM383 injection
PlaceboOther
Matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | CM383 injection, Intravenous infusion Receives: Biological: Alzheimer Disease (AD); Other: Placebo |
| Group 2 | Experimental | CM383 injection, Intravenous infusion Receives: Biological: Alzheimer Disease (AD); Other: Placebo |
| Group 3 | Experimental | CM383 injection, Intravenous infusion Receives: Biological: Alzheimer Disease (AD); Other: Placebo |
| Group 4 | Experimental | CM383 injection, Intravenous infusion Receives: Biological: Alzheimer Disease (AD); Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
The occurrence of adverse events.
Measured: Up to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start8 Nov 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiong Shi, Principal investigator, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619613
- Sponsor's protocol ID
- CM383-109001
- Status last verified
- Mar 2025
- First submitted
- 27 Sep 2024
- Last updated
- 19 Mar 2025
- 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 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled and Multiple Dose Escalation Phase Ib Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM383 in Patients With Alzheimer's Disease Related Mild Cognitive Impairment and Mild Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06619613
- Acronym / sponsor ID
- CM383-109001
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 Oct 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 is a randomized, double-blind, placebo-controlled and multiple dose escalation phase Ib study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM383 in patients with Alzheimer's disease related mild cognitive impairment and mild Alzheimer's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Alzheimer Disease (AD), Other: PlaceboCM383 injection, Intravenous infusion |
| Group 2 | Experimental | Biological: Alzheimer Disease (AD), Other: PlaceboCM383 injection, Intravenous infusion |
| Group 3 | Experimental | Biological: Alzheimer Disease (AD), Other: PlaceboCM383 injection, Intravenous infusion |
| Group 4 | Experimental | Biological: Alzheimer Disease (AD), Other: PlaceboCM383 injection, Intravenous infusion |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Voluntarily participate and have the subject and their legal guardian jointly sign the Informed Consent Form.
- The age of the subjects is between 50 and 85 years old.
- BMI≥19kg/m2 and ≤32.5 kg/m2, weight ≥45 kg and ≤100 kg at screening or baseline.
Key exclusion criteria (7 listed)
- Cognitive impairment of subjects due to other medical or neurological factors (other than AD)
- History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past year
- With any mental illness that may interfere with the cognitive assessment of the subjects.
- With history of moderate or severe renal dysfunction.
- With Uncontrolled stable hypertension.
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 |
|---|---|---|
| Alzheimer Disease (AD)CM383 injection | Biological | Group 1, Group 2, Group 3, Group 4 |
| PlaceboMatched placebo | Other | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Adverse event
Time frame: Up to Week 26
The occurrence of adverse events.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
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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.
Jiong Shi principal investigator
The First Affiliated Hospital of University of Science and Technology of China
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 Alzheimer Disease (AD) 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 7 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: looking for participants now, as of the sponsor's last update on 19 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qian Jia (86 + 02888610620, qianjia@keymedbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event (time frame: Up to Week 26). 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 19 Mar 2025.