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A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B) | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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)

NCT06649110•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)

Detailed Description

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.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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 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

Locations (29)

Stanford Medical Center

Stanford, California, United States

Univ Colorado Hospital

Aurora, Colorado, United States

U of Kansas Medical Center

Kansas City, Kansas, United States

Norton Infectious Diseases Specialists

Louisville, Kentucky, United States

Tufts Medical Center

Boston, Massachusetts, United States

Summit Health Eastside Clinic

Bend, Oregon, United States

Statcare Pulmonary Consultants

Knoxville, Tennessee, United States

PPD Development LP

Austin, Texas, United States

The University of Utah

Salt Lake City, Utah, United States

Pul Ass Richmond Inc P A R

Richmond, Virginia, United States

Key Dates

Start Date

October 24, 2024

Primary Completion Date

November 29, 2028

Completion Date

December 31, 2028

Last Updated

March 9, 2026

Enrollment

232

ESTIMATED participants

Conditions

Healthy Volunteers, Pulmonary Arterial Hypertension

Interventions

LTP

DRUG

Placebo

DRUG

Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111