Phase I, Pharmacokinetic, Safety and Tolerability Study in Healthy Volunteers
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.
How it ended
Completed on 2018-12-20, after 2017-10-17 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2018-12-20. 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.
What moved the score
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: ulntolerabilitydefinedivactive
Phrases that lowered it: healthyvolunteersvaccinationtocilizumabkg -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Drug's FAERS reports with a death: 7.3% (lowers risk) · Drug's FDA history
-
Blinding: triple (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 80.5% (lowers risk) · Drug's FDA history
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Number of arms: 3 (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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.
The trial
Design
- Phase
- 1 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 55 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 21999 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 7782 (typical: 412.5)
- Drug's FAERS reports marked serious
- 80.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- tocilizumab
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Comparative Study of 3 Tocilizumab Products in Normal Healthy Volunteeers NCT04885829 · started 2021 · scored riskier than 2% of active trials completed
- A Clinical Study Aiming to Assess Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TRX-100 in Healthy Volunteers NCT06757738 · started 2024 · scored riskier than 5% of active trials completed
- First in Human Study to Assess Safety of VIS649 in Healthy Subjects NCT03719443 · started 2018 · scored riskier than 4% of active trials completed
- Safety, Tolerability and Pharmacokinetics of FTP-198 in Healthy Australian Volunteers NCT04526496 · started 2020 · scored riskier than 3% of active trials completed
- Сlinical Study Aiming to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of ZE63-0302 in Healthy Volunteers NCT06780124 · started 2024 · scored riskier than 4% 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.