Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study of M5049 in Healthy Participants
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 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 2019-07-26, after 2018-09-20 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 2019-07-26. 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: ascendingsafety tolerabilityplacebo controlledblind placebodoses
Phrases that lowered it: participantsparticipantkghealthybody weight -
Primary purpose: other (lowers risk) · Design
-
Sponsor's past termination rate: 12.8% (raises risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 24 (lowers risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
-
Blinding: double (raises risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Sponsor's past trials: 149 (lowers risk) · Sponsor's track record
-
Number of arms: 5 (lowers risk) · Design
-
Disease area, cancer: 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
- 5 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- other (typical: treatment)
- Blinding
- double (typical: 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
- 45 (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
- 149 (typical: 32)
- Sponsor's past termination rate
- 12.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 24 (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
- Study of M5049 in Healthy Japanese and Caucasian Participants NCT04880213 · started 2021 · scored riskier than 2% of active trials completed
- A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers NCT01762397 · started 2012 · scored riskier than 2% of active trials completed
- An Ascending Dose Study to Evaluate M281 Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) NCT02828046 · started 2016 · scored riskier than 4% of active trials completed
- Multiple Dose Escalation Study of M201-A in Healthy Japanese Subjects NCT04464681 · started 2020 · scored riskier than 2% of active trials completed
- A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-6345 in Healthy Subjects NCT03809039 · started 2019 · scored riskier than 4% of active trials terminated
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.