Peptide Library

Human study PLS-00213

Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of Intravenous (IV) Infusion of MTP-131 (Bendavia™) in Healthy Adults

Other design · 40 participants enrolled

Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Reports of this study

Every publication, registration and abstract describing this one study. Participants are counted once.

  • Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of Intravenous (IV) Infusion of MTP-131 (Bendavia™) in Healthy Adultsregistry entry · NCT01115920 (COMPLETED, no results posted, planned enrollment 40)

Design and participants

Design
Other design
Population
Healthy adults
Conditions
Healthy
Planned enrollment (registry)
40
Enrolled
40
Randomized
Not reported
Completed follow-up
Not reported

Intervention and comparator

What each group received. Related peptides, analogs and combinations are never treated as the compound itself.

  • MTP-131 (Bendavia) IV infusion (intervention) · elamipretide · MTP-131 (Bendavia), the development name for elamipretide, given by intravenous infusion; the registry does not describe the arm structure or any comparator · intravenous infusion · Not reported assigned

What the authors reported

As stated in the sources. This is the authors’ account, not Peptide Library’s assessment.

Safety and tolerability

unclear outcome · safety

  • No results reported.

Pharmacokinetics

unclear outcome · surrogate

  • No results reported.

Adverse events

None reported. That is not evidence of safety, and how safety was monitored isn’t described.

Peptide Library’s assessment

An automated assessment, made by AI separately from the authors’ conclusions and not reviewed by a person. How risk of bias is assessed.

Limitations

  • abstract only: Only the ClinicalTrials.gov registration is available. There is no publication, abstract or posted results, so methods and findings cannot be assessed.
  • selective reporting: The study is registered as completed but has_results is false, so its outcome data have not been made publicly available in the record.
  • inappropriate population: Participants were healthy adults, so the study cannot address efficacy in Barth syndrome or primary mitochondrial myopathy.
  • small or imprecise: Actual enrollment was 40 healthy adults in a Phase 1 study, which is too few for reliable estimates of uncommon adverse events.
  • other: The registry does not state whether participants were randomized, whether a placebo group existed, or how arms were structured.
  • inappropriate endpoint: Registered outcomes are safety and pharmacokinetics; no function, exercise or fatigue outcomes are recorded.

No risk-of-bias assessment has been published for this study’s results.

Claims this study informs

Where each value comes from

  • arms: NCT NCT01115920, registry (interventions field) · extracted by AI (automated, not verified by a person)
  • design: NCT NCT01115920, registry (phases and study_type fields) · extracted by AI (automated, not verified by a person)
  • limitations: NCT NCT01115920, registry (status and has_results fields) · extracted by AI (automated, not verified by a person)
  • outcomes: NCT NCT01115920, title (study title) · extracted by AI (automated, not verified by a person)
  • participants: NCT NCT01115920, registry (enrollment and enrollment_type fields) · extracted by AI (automated, not verified by a person)
  • population: NCT NCT01115920, registry (conditions field) · extracted by AI (automated, not verified by a person)

  • Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

These assessments describe published research. Records marked automated were produced by AI under the published methodology and have not been reviewed by a person; they can contain errors. None of this is medical advice, not a statement about any product’s safety for human use, and not a regulatory approval. Peptide Library’s vendor and partner relationships play no part in them (editorial independence).