A Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered Intravenously in Healthy Adult Volunteer Participants
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 2020-12-23, after 2020-08-10 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 2020-12-23. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: to determineplaceboheartmsecprior
Phrases that lowered it: healthyvolunteersinvestigatorpharmacokineticsmale -
Sponsor's past termination rate: 12.2% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Drug's FAERS reports marked serious: 60.2% (lowers risk) · Drug's FDA history
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Minimum age: 19 (lowers risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 36 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 4.3% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Blinding: double (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Maximum age: 55 (lowers risk) · Who can join
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
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 19 (typical: 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
- 490 (typical: 32)
- Sponsor's past termination rate
- 12.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 36 (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
- 304 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 167 (typical: 412.5)
- Drug's FAERS reports marked serious
- 60.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 4.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- lanadelumab
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 to Determine the Bioavailability of Lanadelumab (SHP643) Administered Subcutaneously With the Prefilled Syringe and the Autoinjector in Healthy Adult Volunteer Participants. NCT03918239 · started 2019 · scored riskier than 2% of active trials completed
- Study of Lanadelumab in Healthy Japanese and Matched Caucasian Adult Subjects NCT03401671 · started 2018 · scored riskier than 2% of active trials completed
- Healthy Volunteer Study Comparing Tablet and Oral Solution Formulations NCT04814472 · started 2021 · scored riskier than 0% of active trials completed
- A Phase 1 Study in Healthy Volunteers to Evaluate the Relative Bioavailability of ALG-055009 Formulations NCT06959888 · started 2025 · scored riskier than 3% of active trials completed
- A Single and Multiple Ascending Dose Study of LAD603 in Healthy Subjects NCT06200597 · started 2023 · 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.