Human study PLS-00217
The Impact of Intravenous Bendavia™ on Endothelial Reactivity Dysfunction in Cigarette Smoking
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.
- The Impact of Intravenous Bendavia™ on Endothelial Reactivity Dysfunction in Cigarette Smokingregistry entry · NCT01518985 (COMPLETED, no results posted, planned enrollment 6)
Design and participants
- Design
- Other design
- Population
- Healthy volunteers exposed to cigarette smoking. Smoking status and other eligibility details are not stated in the record.
- Conditions
- Healthy Volunteers, Endothelial reactivity dysfunction in cigarette smoking
- Planned enrollment (registry)
- 6
- Enrolled
- 6
- 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.
- Bendavia (intervention) · elamipretide · Bendavia (elamipretide, SS-31), given intravenously according to the title; listed alongside a cigarette smoking intervention · intravenous · Not reported assigned
- Sterile saline (comparator) · Sterile saline (0.9%), presumably the placebo control; listed alongside a cigarette smoking intervention · placebo · Not reported assigned
What the authors reported
As stated in the sources. This is the authors’ account, not Peptide Library’s assessment.
Endothelial reactivity
unclear outcome · surrogate · Not stated in the record; inferred only from the study title
- 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 a registry entry is available. It has no posted results, abstract or publication, so outcomes, methods and findings cannot be appraised.
- small or imprecise: Actual enrollment was only 6 participants, per the registry record.
- inappropriate endpoint: The title points to endothelial reactivity, a vascular surrogate, rather than patient-important outcomes.
- inappropriate population: Participants were healthy volunteers undergoing a cigarette smoking challenge, not patients with mitochondrial disease such as Barth syndrome or primary mitochondrial myopathy.
- selective reporting: The study is marked completed but has_results is false. No findings have been reported in the record.
- other: The record does not state whether allocation between Bendavia and saline was randomized, blinded or crossover.
No risk-of-bias assessment has been published for this study’s results.
Claims this study informs
- Improves function in Barth syndrome: not eligible (wrong population) for “Muscle strength, exercise capacity and fatigue”
- Improves exercise capacity in primary mitochondrial myopathy: not eligible (wrong population) for “Six-minute walk distance and fatigue”
- Is safe for human administration: not eligible (insufficient data) for “Adverse events, including injection-site reactions, and discontinuations”
Where each value comes from
- arms: NCT NCT01518985, registry (interventions field) · extracted by AI (automated, not verified by a person)
- design: NCT NCT01518985, registry (phases, study_type fields) · extracted by AI (automated, not verified by a person)
- outcomes: NCT NCT01518985, title (study title) · extracted by AI (automated, not verified by a person)
- participants: NCT NCT01518985, registry (enrollment, enrollment_type fields) · extracted by AI (automated, not verified by a person)
- population: NCT NCT01518985, 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).