A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of ZYIL1 Following Oral Administration in Healthy Volunteers
Model scores of the 29,894 trials active now.
Model score 5% 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 2021-10-25, after 2021-07-12 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 2021-10-25. 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: subjectssafety tolerabilitytolerability pharmacokineticsthe subjectdefined
Phrases that lowered it: healthyvolunteerskggrapefruitopen label -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Sponsor's past termination rate: 25% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Design: single group (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Blinding: none (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (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
- 8 (typical: 32)
- Sponsor's past termination rate
- 25% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 6 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- none matched
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
- Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of ZYIL1 Following Oral Administration in Healthy Volunteers NCT04731324 · started 2020 · scored riskier than 4% of active trials completed
- A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZYIL1 in Subjects With Cryopyrin Associated Periodic Syndromes (CAPS) NCT05186051 · started 2022 · scored riskier than 24% of active trials completed
- A Phase 1, Evaluate the Safety, Tolerability, and Pharmacokinetics of INS018_055 in Healthy Subjects NCT05154240 · started 2022 · scored riskier than 6% of active trials completed
- A Study Of Zy-19489 Administered Via Oral Route To Investigate The Safety, Tolerability And Pharmacokinetics In Healthy Adult Human Subjects NCT05206201 · started 2021 · scored riskier than 10% of active trials completed
- Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Food Effect and DDI of Ascending Doses of the MEK Inhibitor Zapnometinib NCT05555823 · started 2022 · 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.