A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TNX-1500 in Healthy Subjects
Model scores of the 29,894 trials active now.
Model score 8% 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 2024-02-22, after 2023-07-18 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 2024-02-22. 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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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Sponsor's past termination rate: 20.8% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: ascendingdlsafety tolerabilitytolerability pharmacokineticsand pharmacodynamics
Phrases that lowered it: healthyscreeninghepatitisozpositive -
Phase: 1 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Number of arms: 4 (lowers risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Sponsor's past trials: 24 (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 6 (lowers risk) · Sponsor's track record
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Collaborators: 1 (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
- 4 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- basic science (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 65 (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
- 24 (typical: 32)
- Sponsor's past termination rate
- 20.8% (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
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 8 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- 87.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- keyhole limpet hemocyanin
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
- A Study of Subcutaneous DR-01 in Healthy Volunteers NCT06766864 · started 2025 · scored riskier than 4% of active trials completed
- A First-in-human Study of YN001 in Healthy Volunteers NCT05635084 · started 2022 · scored riskier than 5% of active trials completed
- A Phase I Pharmacokinetics Study for KT07 Capsule NCT05223660 · started 2022 · scored riskier than 3% of active trials completed
- Study to Evaluate Safety and PK of a Single IM Dose of G03-52-01 vs Placebo in Adult Subjects NCT04171115 · started 2020 · scored riskier than 5% of active trials completed
- Study of CD388 Subcutaneous Administration in Healthy Japanese Subjects NCT05619536 · started 2022 · scored riskier than 3% 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.