Trial reportClinical pharmacokinetics2025
SHR-1918, A Monoclonal Antibody Against Angiopoietin-Like 3, in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Study.
Trial report in Clinical pharmacokinetics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05432544 (A Phase 1, Randomized, Double Blind, Dose-escalation, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Injection of SHR-1918 Injection in Healthy Subjects), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 1, Randomized, Double Blind, Dose-escalation, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Injection of SHR-1918 Injection in Healthy Subjects
Who cites it
2 citing papers in PubMed.
- Efficacy and Safety of Quarterly Dosing SHR-1918 in Patients With Suboptimally Controlled Hyperlipidemia.JACC. Asia · 2026Article
- Antibody-Based Therapeutics for Hypercholesterolemia.Biologics : targets & therapy · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveAngiopoietin-like 3 (ANGPTL3) increases serum low-density lipoprotein cholesterol and triglyceride by reducing their clearance. SHR-1918 is a monoclonal antibody against ANGPTL3. This study assessed the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of SHR-1918 in healthy subjects.
methodsSix dose cohorts (100, 300, 450, 750, 900, and 1200 mg) were planned, each containing 12 healthy subjects randomized (9:3) to receive a single dose of subcutaneous SHR-1918 or placebo. Subjects were followed up to day 148 for the 100-mg cohort and day 190 for the other cohorts.
resultsA total of 72 subjects were enrolled (SHR-1918, n = 54; placebo, n = 18). SHR-1918 was well tolerated at 100-1200 mg. Treatment-emergent adverse events were comparable between the SHR-1918 (90.7%) and placebo (94.4%) groups. All treatment-emergent adverse events were mild or moderate in severity, with no serious adverse events or treatment-emergent adverse events leading to death. Maximum serum concentration was reached 7.98-10.0 days after injection, and mean half-life was 29.4-53.5 days across the dose range. Serum low-density lipoprotein cholesterol and triglyceride markedly and rapidly decreased upon SHR-1918 administration, whereas those in the placebo group were above baseline at most follow-up visits. The largest median percentage decline in serum low-density lipoprotein cholesterol and triglyceride ranged from - 28.7 to - 49.1% and from - 46.6 to - 82.8%, respectively. For dose levels 300 mg or higher, the low-density lipoprotein cholesterol reduction remained over 30% for 64 days and triglyceride reduction remained over 50% for 85 days.
conclusionsSHR-1918 was well tolerated and showed promising efficacy in lipid reduction among healthy subjects. CLINICAL
trial registrationClinicalTrials.gov, NCT05432544 (24 June, 2022).
Indexed as
Identifiers
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.