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Study in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

NCT06560762 · Secretome Therapeutics
In plain English

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Official title
A Phase 1, Open Label, Multiple Ascending Dose Study to Assess Safety and Tolerability of STM-01 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
About this study
A Phase 1, Open label, Multiple Ascending Dose Study to Assess Safety and Tolerability of STM-01 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
Eligibility criteria
Major Inclusion Criteria: * Stable New York Heart Association (NYHA) Class II or III HF diagnosis, evident at least 6 months prior to enrolment as confirmed by medical history. * Documented prior objective evidence of heart failure * Screening ejection fraction ≥50%. * Adequate bone marrow reserve and organ function at the Screening * Receiving standard of care heart failure therapy at stable doses for at least 30 days prior to Screening. Major Exclusion Criteria: * Participant in any other study and has received any other investigational drug within 30 days prior to screening or 5-half-lives, whichever is longer, or any other investigational implanted device within 30 days prior to screening, or are taking part in a nonmedication study which, in the opinion of the Investigator, would interfere with study compliance or outcome assessments. * Prior diagnosis of hypertrophic cardiomyopathy or a known infiltrative or storage disorder causing HFpEF and/or cardiac hypertrophy, such as amyloidosis, Fabry disease, or Noonan syndrome with LV hypertrophy. * Persistent or permanent atrial fibrillation and is not therapeutically anticoagulated for at least the 4 weeks prior to the initial screening visit or is not adequately rate controlled within 6 months prior to informed consent according to investigator discretion. * Other medical or psychiatric conditions that, in the opinion of the Investigator, would preclude obtaining voluntary consent/assent or would confound the objectives of the study.
Study design
Enrollment target: 12 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-03-03
Estimated completion: 2025-12-15
Last updated: 2025-04-06
Interventions
Drug: STM01
Primary outcomes
  • Frequency, grade and relationship to STM-01 of unsolicited local and systemic AEs (any SAEs, MAAEs and AESIs ) during the 60-d follow-up period post IV infusion at D0 and D28 per the CTCAE v5.0 and clinical-safety laboratory parameters up to D 56. (Dose 1 (Day 0) till end of study (Day 56))
Sponsor
Secretome Therapeutics · industry
Contacts & investigators
ContactMalika Pasha · contact · mpasha@secretometx.com · 4155352700
All locations (2)
Northwestern MedicineNot Yet Recruiting
Chicago, Illinois, United States
UT Southwestern Medical CenterRecruiting
Dallas, Texas, United States