Single Ascending Doses of HER-096 in Healthy Subjects
Model scores of the 29,894 trials active now.
Model score 6% 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 8% of the time (544 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-09-29, after 2023-03-29 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 2023-09-29. 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
-
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: hepatitisvirustypeto severecause
Phrases that lowered it: healthymmhgexaminationthe studymale -
Sponsor's past termination rate: 25% (raises risk) · Sponsor's track record
-
Minimum age: 20 (lowers risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Disease area, neurology: Yes (raises risk) · Disease area
-
Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
-
Sponsor's past trials: 4 (lowers risk) · Sponsor's track record
-
Number of arms: 3 (lowers risk) · Design
-
Design: sequential (raises risk) · Design
-
Blinding: quadruple (lowers risk) · Design
-
Collaborators: 1 (raises risk) · Design
-
Disease area, psychiatry: 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
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 1
Who can join
- Minimum age
- 20 (typical: 18)
- Maximum age
- 75 (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
- 4 (typical: 32)
- Sponsor's past termination rate
- 25% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- neurology
- 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 of HER-096 in Healthy Volunteer Subjects and Patients With Parkinson's Disease NCT06659562 · started 2024 · scored riskier than 9% of active trials completed
- A Study of BRII-297 in Healthy Adult Subjects NCT05845840 · started 2023 · scored riskier than 3% of active trials completed
- A FIH Study to Investigate the Safety, Tolerability and PK of P218 NCT02885506 · started 2016 · scored riskier than 12% of active trials completed
- First-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV367 NCT05507970 · started 2022 · scored riskier than 5% of active trials completed
- Multiple-Dose, Dose-Escalation Study to Evaluate the Safety/Tolerability and Pharmacokinetics of FP-045 NCT03686930 · started 2018 · 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.