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LTP001 IN PAH/CLTP001A12202: A single and multiple ascending dose study in healthy participants and an evaluation of efficacy and safety of LTP001 in PAH participants A randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of LTP001 in healthy adult participants (Part A) and to evaluate the efficacy and safety of LTP001 for the treatment of participants with pulmonary arterial hypertension (Part B)

Clinical Trials

Purpose

The CLTP001A12202 study will explore the safety, tolerability, and pharmacokinetics of LTP001 in healthy volunteers (Part A) and will evaluate the safety and efficacy (Part B) followed by safety extension in participants with pulmonary arterial hypertension.

Inclusion Criteria

Ages Eligible for Study 

18 Years to 100 Years (Adult,  Older Adult )

Sexes Eligible for Study 

All

Accepts Healthy Volunteers 

Yes

Part A Inclusion Criteria:

  • Healthy males and non-child-bearing potential females

Part B Inclusion Criteria:

-Confirmed diagnosis of PAH, pre-randomization PVR ≥400 dyn.sec.cm-5, treatment with stable doses of standard-of-care PAH therapies, 6-minute walk distance ≥ 150 m and ≤450 m.

Exclusion Criteria

Part A Exclusion Criteria:

  • Clinically significant ECG or cardiac abnormalities, any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the participant in the study Other protocol-defined inclusion/exclusion criteria may apply.

Part B Exclusion Criteria:

Any surgical or medical condition which may place the participant at higher risk from his/her participation in the study Women of child-bearing potential unless they are using highly effective methods of contraception Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 24 hours after stopping study treatment.

History of hypersensitivity to any of the study treatments or excipients

Other protocol-defined inclusion / exclusion criteria may apply

NCT: NCT06649110
Hayah Kassis-George, MD
Heart Failure and Transplantation Cardiology
Allegheny General Hospital
Contact

For more information about this trial, please send an email to ClinicalTrials@ahn.org.

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