Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults
Model scores of the 29,894 trials active now.
Model score 5% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 6% of the time (340 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-12-07, after 2021-11-16 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 2022-12-07. 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: ascendingtolerabilitytherapyinterferonplacebo controlled
Phrases that lowered it: healthyvaccineparticipantevaluate theto evaluate -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: 100% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Blinding: double (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 3 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 1 (lowers risk) · Sponsor's track record
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Collaborators: 1 (raises risk) · Design
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (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
- 18
- Maximum age
- 49 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 1 (typical: 32)
- Sponsor's past termination rate
- 100% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 3 (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
- infectious disease
- 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
- To Assess the Safety and Tolerability of MTx-COVAB36 as a Therapeutic and Prophylactic Treatment Against COVID-19. NCT05351437 · started 2022 · scored riskier than 3% of active trials completed
- A Safety, Tolerability, Pharmacokinetics and Immunogenicity Trial of Co-administered MERS-CoV Antibodies REGN3048 and REGN3051 NCT03301090 · started 2018 · scored riskier than 5% of active trials completed
- Assessment of CR6261, a Monoclonal Antibody Against the Influenza A Virus NCT01406418 · started 2013 · scored riskier than 2% of active trials completed
- Assessment of CR8020, a Monoclonal Antibody Against Influenza A Viruses NCT01756950 · started 2013 · scored riskier than 2% of active trials completed
- A Study to Evaluate the Safety and Reactogenicity of DPX-RSV(A), a Respiratory Syncytial Virus Vaccine NCT02472548 · started 2015 · 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.