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
Status: Recruiting
Location: See location...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 85
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
The First Affiliated Hospital of University of Science and Technology of China
RECRUITING
Hefei
Contact Information
Primary
Qian Jia
qianjia@keymedbio.com
86 + 02888610620
Time Frame
Start Date: 2024-11-08
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 48
Treatments
Experimental: Group 1
CM383 injection, Intravenous infusion
Experimental: Group 2
CM383 injection, Intravenous infusion
Experimental: Group 3
CM383 injection, Intravenous infusion
Experimental: Group 4
CM383 injection, Intravenous infusion
Related Therapeutic Areas
Sponsors
Leads: Keymed Biosciences Co.Ltd