Last Update: Jul 21, 2026 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) ClinicalTrials.gov Identifier: [NCT06649110](https://clinicaltrials.gov/ct2/show/NCT06649110) Novartis Reference Number:CLTP001A12202 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B) 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. Condition Healthy Volunteers, Pulmonary Arterial Hypertension Phase Phase1, Phase2 Overall Status Recruiting Number of Participants232 Start Date Oct 24, 2024 Completion Date Dec 31, 2028 Gender All Age(s) 18 Years - 100 Years (Adult, Older Adult) ## Interventions Drug ### LTP LTP001 Drug ### Placebo Placebo ## Eligibility Criteria Part A Inclusion Criteria: \* Healthy males and non-child-bearing potential females 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. \* For Japanese cohorts: participants per protocol should be first generation Japanese or up to third generation Japanese as defined in inclusion criteria 7 of the protocol. 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. 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. 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