Related Experiment Video
Updated: Aug 10, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Safety, Tolerability, and Pharmacokinetics of Donanemab in Healthy Chinese Participants: A Phase 1, Randomized,
Junyu Xu1, Nan Zhao1, Yihui Wang2
1Drug Clinical Trial Institution, Peking University First Hospital, Beijing, China.
Abstract:
Alzheimer's disease (AD), characterized by β-amyloid (Aβ) plaques and neurofibrillary tangles, is the leading cause of dementia globally. Donanemab is a humanized immunoglobulin G1 in development as a treatment to slow AD progression. This study aimed to evaluate the safety, tolerability, pharmacokinetics (PKs), and immunogenicity of donanemab in healthy Chinese adults. The study included screening, inpatient, and follow-up periods. Following successful screening, participants were assigned to one of three donanemab cohorts (350, 700, or 1400 mg) and randomized in a 5:1 ratio to receive donanemab or placebo. Participants received a single intravenous (IV) dose of donanemab or placebo, and the safety, PKs, and immunogenicity of donanemab were monitored. A total of 36 male Chinese participants were included. All treatment-emergent adverse events (TEAEs) were mild in severity. Two participants on 350 mg donanemab experienced treatment-related TEAEs. Serum concentrations decreased over time with dose-dependent PK parameters (Cmax, t1/2, AUC0-tlast, and AUC0-inf) as expected. Clearance values were similar across doses. All donanemab recipients developed treatment-emergent antidrug antibodies (ADAs) in the inpatient and follow-up periods, with similar ADA titer ranges across all donanemab doses. Single IV doses of donanemab 350, 700, and 1400 mg showed acceptable safety, tolerability, and dose-proportional PK in healthy Chinese adults.
More Related Videos
08:17A Human Peripheral Blood Mononuclear Cell PBMC Engrafted Humanized Xenograft Model for Translational Immuno-oncology I-O Research
Published on: August 15, 2019
06:37Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety
Published on: September 15, 2023
Related Concept Videos
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Bioavailability Study Design: Single Versus Multiple Dose Studies
Bioavailability Study Design: Healthy Subjects Versus Patients
Bioavailability Enhancement: Drug Stability Enhancement and GI Retention
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs
Modified-Release Drug Delivery Systems: Bioavailability