Healthy Volunteers, Pulmonary Arterial HypertensionPhase 1/2NCT06649110
A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)
A Phase 1/2 study testing LTP in people with Healthy Volunteers, Pulmonary Arterial Hypertension, run by Novartis Pharmaceuticals at 87 sites in 18 countries.
Trial summary
A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B) Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Pulmonary Arterial Hypertension
- What is being tested?
- LTP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- 87 sitesin 18 countries
- Study dates
- 24 Oct 2024to 31 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
History of hypersensitivity to any of the study treatments or excipients
Other protocol-defined inclusion / exclusion criteria may apply
Trial locations and contacts
87 sites in 18 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
87 sites in 18 countries
United States20 sites, 20 recruiting
- Recruiting
Emory University School of Medicine
Atlanta, Georgia, 30322
+1 404 778 3261
Micah Fisher
- Recruiting
Univ Colorado Hospital
Aurora, Colorado, 80045
+1 720 848 6567
David B Badesch
- Recruiting
PPD Development LP
Austin, Texas, 78744
+1 512 447 2985
Jia Chang
- Recruiting
PPD Development LP
Austin, Texas, 78744
Shawn Searle
- Recruiting
Summit Health Eastside Clinic
Bend, Oregon, 97701
Jeremy Feldman
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
+1 617 636 4288
Nicholas Hill
- Recruiting
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
+1 781 744 3874
Ioana Preston
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
+1 214 645 6488
Kelly Chin
- Recruiting
U of Kansas Medical Center
Kansas City, Kansas, 66160
+1 913 588 9722
Leslie Spikes
- Recruiting
Statcare Pulmonary Consultants
Knoxville, Tennessee, 37919
+1 941 924 9800
John Swisher
- Recruiting
Norton Infectious Diseases Specialists
Louisville, Kentucky, 40202
+1 502 587 8000
John Wesley McConnell
- Recruiting
UC Irvine Medical Center
Orange, California, 92868-3298
+1 714 456 6037
Bassam Yaghmour
- Recruiting
Central Florida Pulmonary Group
Orlando, Florida, 32803-5734
+1 407 841 1100
Syed Mobin
- Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4756
Hayah Kassis-George
- Recruiting
Pul Ass Richmond Inc P A R
Richmond, Virginia, 23230-1709
+1 804 288 5945
Shilpa Johri
- Recruiting
Sky Integrative Medical Center SKYCRNG PPDS
Ridgeland, Mississippi, 39157-5179
Bob Hutchins
- Recruiting
The University of Utah
Salt Lake City, Utah, 84132-0001
+1 801 213 4086
Katharine Clapham
- Recruiting
Arizona Pulmonary Specialists Ltd
Scottsdale, Arizona, 85258
+1 602 271 0832
Akshay Muralidhar
- Recruiting
Stanford Medical Center
Stanford, California, 94305
+1 650 725 5495
Roham Zamanian
- Recruiting
University of South Florida
Tampa, Florida, 33606-3475
+1 813 844 7137
Ricardo Restrepo-Jaramillo
France12 sites, 12 recruiting
- Recruiting
Novartis Investigative Site
Angers, France, 49933
- Recruiting
Novartis Investigative Site
Brest, 29200
- Recruiting
Novartis Investigative Site
Clamart, 92141
- Recruiting
Novartis Investigative Site
Grenoble, 38043
- Recruiting
Novartis Investigative Site
Montpellier, 34295
- Recruiting
Novartis Investigative Site
Nice, 06001
- Recruiting
Novartis Investigative Site
Pessac, 33604
- Recruiting
Novartis Investigative Site
Poitiers, 86021
- Recruiting
Novartis Investigative Site
Saint-Priest-en-Jarez, 42270
- Recruiting
Novartis Investigative Site
Strasbourg, 67091
- Recruiting
Novartis Investigative Site
Toulouse, 31059
- Recruiting
Novartis Investigative Site
Vandœuvre-lès-Nancy, 54511
Germany8 sites, 8 recruiting
- Recruiting
Novartis Investigative Site
Berlin, 13125
- Recruiting
Novartis Investigative Site
Berlin, 14050
- Recruiting
Novartis Investigative Site
Dresden, Saxony, 01307
- Recruiting
Novartis Investigative Site
Giessen, 35392
- Recruiting
Novartis Investigative Site
Greifswald, 17475
- Recruiting
Novartis Investigative Site
Heidelberg, 69120
- Recruiting
Novartis Investigative Site
Homburg, 66421
- Recruiting
Novartis Investigative Site
Regensburg, Bavaria, 93053
Italy8 sites, 8 recruiting
- Recruiting
Novartis Investigative Site
Foggia, FG, 71122
- Recruiting
Novartis Investigative Site
Ivrea, TO, 10015
- Recruiting
Novartis Investigative Site
Monza, MB, 20900
- Recruiting
Novartis Investigative Site
Palermo, PA, 90127
- Recruiting
Novartis Investigative Site
Pavia, PV, 27100
- Recruiting
Novartis Investigative Site
Roma, RM, 00161
- Recruiting
Novartis Investigative Site
Sassari, SS, 07100
- Recruiting
Novartis Investigative Site
Trieste, TS, 34149
Spain7 sites, 7 recruiting
- Recruiting
Novartis Investigative Site
Barcelona, Catalonia, 08003
- Recruiting
Novartis Investigative Site
Barcelona, 08035
- Recruiting
Novartis Investigative Site
Las Palmas de Gran C, Las Palmas, 35016
- Recruiting
Novartis Investigative Site
Marbella, Andalusia, 29600
- Recruiting
Novartis Investigative Site
Santiago Compostela, A Coruna, 15706
- Recruiting
Novartis Investigative Site
Seville, 41013
- Recruiting
Novartis Investigative Site
Toledo, Castille-La Mancha, 45071
Argentina5 sites, 5 recruiting
- Recruiting
Novartis Investigative Site
Buenos Aires, Buenos Aires F.D., 1199
- Recruiting
Novartis Investigative Site
CABA, C1426ABP
- Recruiting
Novartis Investigative Site
Río Cuarto, X5800AEV
- Recruiting
Novartis Investigative Site
San Miguel de Tucumán, T4000AXL
- Recruiting
Novartis Investigative Site
Santa Fe, S3000EOZ
Australia4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Adelaide, South Australia, 5000
- Recruiting
Novartis Investigative Site
Camperdown, New South Wales, 2050
- Recruiting
Novartis Investigative Site
Darlinghurst, New South Wales, 2010
- Recruiting
Novartis Investigative Site
New Lambton Heights, New South Wales, 2305
United Kingdom4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Cambridge, CB2 0AY
- Recruiting
Novartis Investigative Site
London, EC1A 7BE
- Recruiting
Novartis Investigative Site
London, SW3 6PH
- Recruiting
Novartis Investigative Site
Sheffield, South Yorkshire, S10 2JF
Greece3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Athens, 106 76
- Recruiting
Novartis Investigative Site
Chaïdári, 124 62
- Recruiting
Novartis Investigative Site
Thessaloniki, 54636
Mexico3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Monterrey, Nuevo León, 64460
- Recruiting
Novartis Investigative Site
Monterrey, Nuevo León, 64718
- Recruiting
Novartis Investigative Site
San Luis Potosí City, San Luis Potosí, 78200
Serbia3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Belgrade, Serbia, 11000
- Recruiting
Novartis Investigative Site
Kamenitz, 21204
- Recruiting
Novartis Investigative Site
Niš, 18108
Czechia2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Prague, 128 08
- Recruiting
Novartis Investigative Site
Prague, 14021
Portugal2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Almada, 2805-267
- Recruiting
Novartis Investigative Site
Lisbon, 1769 001
Romania2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Bucharest, 050159
- Recruiting
Novartis Investigative Site
Timișoara, Timiș County, 300310
Belgium1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Leuven, Vlaams Brabant, 3000
Brazil1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90035-074
Poland1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Poznan, 61 545
About this study
Official title: 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)
A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
Read the 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.
- Being tested
- LTP, Placebo
- Keywords
- LTP001, pulmonary arterial hypertension, PAH, PVR
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTPDrug
LTP001
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| LTP001 Dose 1 | Experimental | Not described Receives: Drug: LTP |
| LTP001 Dose 2 | Experimental | Not described Receives: Drug: LTP |
| LTP001 Dose 3 | Experimental | Not described Receives: Drug: LTP |
| Placebo | Placebo comparator | matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A- Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Safety endpoints, including vital signs, ECG, clinical laboratory evaluations and adverse events up to and including the end-of-study visit.
Measured: Baseline to Day 35
Part B-Treatment Period 1: Change in pulmonary vascular resistance (PVR)
PVR is a hemodynamic variable of pulmonary circulation and is measured by right heart catheterization.
Measured: Baseline to Week 24
Part B-Treatment Period 2: Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Safety endpoints, including vital signs, ECG, clinical laboratory evaluations, treatment-emergent adverse events and discontinuations due to adverse events.
Measured: From Day 1 until Week 106
Secondary outcomes (10)
Part A- Maximum observed plasma concentrations (Cmax)
Cmax is defined as the maximum (peak) observed concentration following a dose.
Measured: Baseline to Day 35
Part A- Time to reach maximum plasma concentration (Tmax)
Tmax is defined as the time to reach maximum (peak) concentration following a dose.
Measured: Baseline to Day 35
Part A- Area under plasma concentration-time curve from time zero to the last measurable concentration sampling time (AUClast)
AUClast is the area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (tlast).
Measured: Baseline to Day 35
Part A- Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC[0-inf])
The AUC is the area under the plasma concentration from time zero to infinity (mass x time x volume-1).
Measured: Baseline to Day 35
Part A- Terminal elimination half-life (T1/2)
T1/2 is the elimination half-life associated with the terminal slope.
Measured: Baseline to Day 35
Part B-Treatment Period 1: Change in the Six-minute Walk Test (6MWT)
The 6MWD test is self-paced, with standardized instructions and encouragement being given as participants walk as far as possible over 6 minutes through a flat corridor.
Measured: Baseline to Week 24
Part B-Treatment Period 1: Change in N-terminal pro-brain natriuretic peptide (NT-proBNP)
N-terminal pro brain natriuretic peptide (NTproBNP) are peptide (small proteins) that are either hormones or part of the peptide that contained the hormone at one time. They are continually produced in small quantities in the heart and released in larger quantities when the heart senses that it needs to work harder, as in heart failure.
Measured: Baseline to Week 24
Part B-Treatment Period 1: Change in World Health Organization (WHO) functional class (FC)
The Investigator or study staff will assign a WHO functional class to a participant based on reports of symptoms and activity limitation.
- Class I: symptom-free when physically active or resting.
- Class II: no symptoms at rest, but normal activities such as climbing the stairs, grocery shopping, or making the bed cause some discomfort and shortness of breath.
- Class III: resting may be symptom-free, but normal chores around the house are greatly limited due to shortness of breath and feeling tired.
- Class IV: symptoms at rest and severe symptoms with an activity
Measured: Baseline to Week 24
Part B-Treatment Period 2: Change in the Six-minute Walk Test (6MWT)
The 6MWD test is self-paced, with standardized instructions and encouragement being given as participants walk as far as possible over 6 minutes through a flat corridor.
Measured: Baseline to Month 18
Part B-Treatment Period 2: Change in World Health Organization (WHO) functional class (FC)
The Investigator or study staff will assign a WHO functional class to a participant based on reports of symptoms and activity limitation.
- Class I: symptom-free when physically active or resting.
- Class II: no symptoms at rest, but normal activities such as climbing the stairs, grocery shopping, or making the bed cause some discomfort and shortness of breath.
- Class III: resting may be symptom-free, but normal chores around the house are greatly limited due to shortness of breath and feeling tired.
- Class IV: symptoms at rest and severe symptoms with an activity
Measured: Baseline to Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start24 Oct 2024
- Primary completion29 Nov 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers, Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649110
- Sponsor's protocol ID
- CLTP001A12202
- Status last verified
- Jul 2026
- First submitted
- 17 Oct 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 ID
- NCT06649110
- Acronym / sponsor ID
- CLTP001A12202
- Keywords
- LTP001, pulmonary arterial hypertension, PAH, PVR
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 29 Nov 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LTP001 Dose 1 | Experimental | Drug: LTP |
| LTP001 Dose 2 | Experimental | Drug: LTP |
| LTP001 Dose 3 | Experimental | Drug: LTP |
| Placebo | Placebo comparator | Drug: Placebomatching placebo |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LTPLTP001 | Drug | LTP001 Dose 1, LTP001 Dose 2, LTP001 Dose 3 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Part A- Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Time frame: Baseline to Day 35
Safety endpoints, including vital signs, ECG, clinical laboratory evaluations and adverse events up to and including the end-of-study visit.
Part B-Treatment Period 1: Change in pulmonary vascular resistance (PVR)
Time frame: Baseline to Week 24
PVR is a hemodynamic variable of pulmonary circulation and is measured by right heart catheterization.
Part B-Treatment Period 2: Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Time frame: From Day 1 until Week 106
Safety endpoints, including vital signs, ECG, clinical laboratory evaluations, treatment-emergent adverse events and discontinuations due to adverse events.
10 secondary outcomes
Part A- Maximum observed plasma concentrations (Cmax)
Time frame: Baseline to Day 35
Part A- Time to reach maximum plasma concentration (Tmax)
Time frame: Baseline to Day 35
Part A- Area under plasma concentration-time curve from time zero to the last measurable concentration sampling time (AUClast)
Time frame: Baseline to Day 35
Part A- Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC[0-inf])
Time frame: Baseline to Day 35
Part A- Terminal elimination half-life (T1/2)
Time frame: Baseline to Day 35
Part B-Treatment Period 1: Change in the Six-minute Walk Test (6MWT)
Time frame: Baseline to Week 24
Part B-Treatment Period 1: Change in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Time frame: Baseline to Week 24
Part B-Treatment Period 1: Change in World Health Organization (WHO) functional class (FC)
Time frame: Baseline to Week 24
Part B-Treatment Period 2: Change in the Six-minute Walk Test (6MWT)
Time frame: Baseline to Month 18
Part B-Treatment Period 2: Change in World Health Organization (WHO) functional class (FC)
Time frame: Baseline to Month 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Related trials for Healthy Volunteers, Pulmonary Arterial Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
Not yet recruitingPhase 1
A Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of MN-08 Tablets
Pulmonary Arterial Hypertension
RecruitingPhase 1
Safety, Tolerability and Pharmacokinetics Study of L608 in Healthy Adults
Healthy Adult Participants
RecruitingPhase 1
Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease
Asthma, COPD
RecruitingPhase 1
Preliminary Human Trials of F230 Tablets
Pulmonary Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
87 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LTP in people with Healthy Volunteers, Pulmonary Arterial Hypertension, run by Novartis Pharmaceuticals at 87 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 87 sites in United States, France, Germany, Italy, Spain and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A- Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs) (time frame: Baseline to Day 35). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.