A Study of Pharmacokinetics, Safety, and Immunogenicity of BCD-057 100 mg/mL, BCD-057 50 mg/mL, and Humira 100 mg/mL in Healthy Subjects

Model scores of the 29,894 trials active now.

Model score 3% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2026-02-12. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: tumorrandomizationchronicmonoclonalhours
  Phrases that lowered it: healthypharmacokineticsscreeningrangekg
• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Sponsor's past termination rate: 3.8% (lowers risk) · Sponsor's track record
• Primary purpose: other (lowers risk) · Design
• Phase: 1 (lowers risk) · Design
• Drug's FAERS reports marked serious: 56.1% (lowers risk) · Drug's FDA history
• Design: parallel (raises risk) · Design
• Drug's FAERS reports with a death: 4.2% (lowers risk) · Drug's FDA history
• Blinding: triple (raises risk) · Design
• Drug's FAERS reports in the prior 12 months: 28229 (raises risk) · Drug's FDA history
• Has a data monitoring committee: No (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Number of arms: 3 (lowers risk) · Design
• Sponsor's past trials: 52 (lowers risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 14 (lowers risk) · Sponsor's track record
• Disease area, neurology: No (lowers risk) · Disease area
• Drug's FAERS reports before start: 523915 (raises risk) · Drug's FDA history

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

• A Study to Assess the PK, PD, Safety and Immunogenicity of Single IV Infusion of BCD-264 and Darzalex in Healthy Subjects NCT05974969 · started 2023 · scored riskier than 1% of active trials completed
• Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS NCT04018599 · started 2019 · scored riskier than 2% of active trials completed
• Comparative Clinical Study of Pharmacokinetics, Tolerance and Safety of BCD-057 and Humira in Healthy Volunteers NCT02395055 · started 2015 · scored riskier than 1% of active trials completed
• Study to Determine the Pharmacokinetic (PK) Bioequivalence of ABP 501 and Adalimumab (Humira®) in Healthy Adult Japanese Participants NCT05995691 · started 2014 · scored riskier than 3% of active trials completed
• Assessment of Pharmacokinetics and Safety of M923 Administered Via Auto-injector or Prefilled Syringe, in Healthy Subjects NCT02675023 · started 2016 · scored riskier than 2% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.