CM512 Phase 1 Trial: Safety and Pharmacokinetics in Healthy Volunteers

CM512, a novel bispecific antibody targeting TSLP and IL-13, was well tolerated with a low immunogenicity rate of 3.1% in a first-in-human phase 1 study. The data includes safety, pharmacokinetic, and pharmacodynamic results from 64 healthy participants across single and multiple ascending dose cohorts. Authored by Yue Cheng and shared under CC-BY-4.0, this 34.5 KB document details the trial's outcomes.

Use Cases

• Modeling dose-exposure relationships based on linear, dose-proportional pharmacokinetics from 150–1200 mg
• Assessing safety profiles for novel bispecific antibodies based on treatment-emergent adverse event incidence data
• Evaluating target engagement and biomarker modulation based on reductions in free TSLP, IL-13, eosinophils, IgE, and TARC
• Analyzing immunogenicity risk for subcutaneous biologics based on anti-drug antibody incidence rates

Strengths

• Includes detailed results from both single (40 participants) and multiple ascending dose (24 participants) phases
• Reports specific pharmacokinetic parameters like terminal half-life (58.7-73.6 days) and accumulation ratios (2.50-3.17)
• Provides concrete biomarker response data for key type 2 inflammation indicators

Limitations

• Row count is unknown, which may limit suitability assessment
• Column-level documentation is absent; field semantics must be inferred after download
• The 34.5 KB file size suggests a summary document rather than a raw dataset

Provenance

Source

Clinical trial (NCT06553209), results shared via figshare

Collection Method

Randomized, double-blind, placebo-controlled phase 1 study

Freshness

Last updated 2026-05-28 10:39:30; freshness should be verified