RecruitingPhase 1Phase 2NCT06649110
A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)
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)
Sponsor
Novartis Pharmaceuticals
Enrollment
232 participants
Start Date
Oct 24, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
Eligibility
Min Age: 18 YearsMax Age: 100 Years
Inclusion Criteria2
- Healthy males and non-child-bearing potential females
- 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 Criteria2
- 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
Interventions
DRUGLTP
LTP001
DRUGPlacebo
Placebo
Locations(29)
View Full Details on ClinicalTrials.gov
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NCT06649110