BAT1806 Phase I Clinical Trial: Pharmacokinetics and Safety in Healthy Chinese Men

Hong Zhang published a Phase I clinical trial comparing biosimilar BAT1806 to reference drugs RoActemra-EU and Actemra-US. The study includes pharmacokinetic, immunogenicity, and tolerance data from 129 healthy Chinese male participants over a 57-day follow-up period. Results show bioequivalence with low intersubject variability ranging from 14.5% to 21.5%.

Use Cases

• Compare pharmacokinetic parameters (Cmax, AUC) between biosimilar and reference biologics.
• Analyze immunogenicity profiles based on anti-drug antibody and neutralizing antibody rates.
• Evaluate safety and tolerance through treatment-emergent adverse event (TEAE) incidence.
• Assess intersubject variability in drug response within a homogeneous population.
• Conduct sensitivity analyses for bioequivalence testing in regulatory submissions.

Strengths

• Data from a randomized, double-blind, three-arm parallel study design.
• Includes specific pharmacokinetic metrics with 90% confidence intervals (e.g., 86.90–104.41% for BAT1806 vs. RoActemra-EU).
• Reports concrete participant counts (n=45, 42, 42) and adverse event frequencies (27, 34, 32).
• Provides immunogenicity results with antibody positivity rates (e.g., 42.2% for BAT1806).

Limitations

• Column-level documentation is absent; field semantics must be inferred after download.
• Row count is unknown, which may limit suitability assessment.
• Data is limited to a single demographic (healthy Chinese men) and a 57-day observation period.

Provenance

Source

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Collection Method

Data likely originates from a randomized, double-blind, single-dose clinical trial.

Time Range

Study follow-up period was 57 days.

Freshness

Last updated 2026-05-22 15:22:14; freshness should be verified.

Geography

Participants were healthy Chinese men.