Alzheimers disease
Conditions
Interventions
ONC-841 Group 1:Single intravenous infusion of ONC-841 Injection at a dose level of 5 mg/kg.
ONC-841 Group 2:Single intravenous infusion of ONC-841 Injection at a dose level of 10 mg/kg.
ONC-841 Group 3:Single intravenous infusion of ONC-841 Injection at a dose level of 20 mg/kg.
ONC-841 Group 4:Single intravenous infusion of ONC-841 Injection at a dose level of 30 mg/kg.
Placebo group:Single intravenous infusion of 0.9% Sodium Chloride Injection.
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Adult male or female participants aged 18–75 years (inclusive) at the time of signing the informed consent form (ICF). 2. Body weight between 45.0 kg and 100.0 kg (inclusive) at screening, with a body mass index (BMI) of 18.0–28.0 kg/m² (inclusive). 3. Participants must be in good health prior to study drug administration. 4. Female healthy participants must be non-childbearing potential. If of childbearing potential, they must not be pregnant or breastfeeding, must have no plans for pregnancy (for themselves or their partners) during the study and within 6 months after dosing, must agree to use contraception after signing the ICF, throughout the study, and for 6 months after dosing, must not breastfeed during the study and within 6 months after dosing, and must not donate ova within 6 months after dosing. 5. Male healthy participants who have not undergone surgical sterilization must agree not to donate sperm from the time of signing the ICF, throughout the study, and for at least 6 months after study drug administration, and must agree that both they and their partners will have no plans for pregnancy and will use contraception for 6 months after dosing. 6. Participants must have suitable venous access for blood collection and intravenous administration, with no history of syncope related to needles or blood.
Exclusion criteria
Exclusion criteria: 1. History or presence of significant cardiovascular, pulmonary, hepatic, urinary, hematologic, gastrointestinal, endocrine, immune, dermatologic, or neurological diseases. 2. History within 12 months prior to signing the informed consent form, or current sequelae, of gastrointestinal, hepatic, renal, or other diseases known to interfere with drug absorption, distribution, metabolism, or excretion. 3. Any arrhythmia considered by the investigator to make the participant unsuitable for the study, or a history of psychiatric disorders, malignancy, infectious diseases, allergy, or infection that may interfere with the study, as judged by the investigator. 4. Use of any prescription or non-prescription drugs, including herbal products, within 10 days prior to study drug administration (or within 3 months for biologics) or within 5 half-lives of the drug (whichever is longer), or planned use during the study period. 5. Participation in any clinical study involving a drug or non-invasive medical device within 30 days prior to study drug administration (or within 3 months for biologics), participation in a clinical study involving an invasive medical device within 6 months prior to dosing, inability to confirm that the medical device has been completely removed with no residual effects, or still being in the follow-up period of another clinical study at screening. Participants with written documentation confirming that only placebo was used in the previous study are exempt. 6. Receipt of any vaccination within 4 weeks prior to study drug administration or planned vaccination during the study period. 7. Blood donation (including component donation) within 30 days prior to study drug administration, blood loss =400 mL within 3 months prior to dosing, or receipt of blood transfusion within 1 year prior to dosing. 8. Use or planned use of systemic immunosuppressive or immunomodulatory drugs within 3 months prior to study drug administration or during the study period. 9. History of hepatitis B or C infection, human immunodeficiency virus (HIV) infection, or syphilis; or positive results at screening for hepatitis B surface antigen (HBsAg), HIV antibody (HIV-Ab), Treponema pallidum antibody, or hepatitis C virus IgG antibody (HCV-Ab). 10. History of alcohol consumption within 6 months prior to signing the informed consent form, a positive alcohol test during screening or at baseline, or inability to comply with alcohol abstinence requirements during the study period. 11. Smoking more than 10 cigarettes per day within 3 months prior to signing the informed consent form, or inability to comply with smoking restrictions during the study period. 12. History of drug abuse and/or illicit drug use within 1 year prior to signing the informed consent form, or a positive urine drug abuse screening test at screening or baseline. 13. Any other condition that, in the opinion of the investigator, would make the participant unsuitable for the study, including inability to fully comply with study requirements or a likelihood of non-compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, severity, and relationship to study drug of adverse events;Maximum tolerated dose (MTD) and/or safe dose range;Changes in safety assessments from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic characteristics of ONC-841 following a single dose;Immunogenicity characteristics; | — |
Countries
China
Contacts
Public ContactCuibai Wei/Yi Tang
Xuanwu Hospital Capital Medical University
Outcome results
None listed