Pulmonary Arterial Hypertension (PAH)Phase 1NCT06493461
A Study of HS135 for the Treatment of Pulmonary Arterial Hypertension in Adults
A Phase 1 study testing HS135 in people with Pulmonary Arterial Hypertension (PAH), run by 35Pharma Inc., a GSK company at 2 sites in 2 countries.
Trial summary
A Study of HS135 for the Treatment of Pulmonary Arterial Hypertension in Adults Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension (PAH)
- What is being tested?
- HS135
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Oct 2024to 31 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients, 18 years of age and older.
- Body Mass Index (BMI) 18.5 and 40 kg/m2 and body weight at or below 120 kg
- Documented diagnostic RHC at any time prior to screening.
- Diagnosis of WHO PAH Group 1.
- Symptomatic PAH classified as WHO FC II to IV.
- Baseline RHC performed during the Screening Period documenting a minimum PVR of ≥ 5 Wood units (WU) or ≥ 400 dyn・sec・cm-5 and a pulmonary artery wedge pressure (PAWP) of ≤ 15 mmHg.
- On stable doses of at least 2 background PAH therapies.
Who cannot join
- Left ventricular ejection fraction < 50% at screening.
- Any symptomatic coronary disease events within 6 months of the screening visit.
- Uncontrolled systemic hypertension.
- History of restrictive, constrictive or congestive cardiomyopathy.
- History of atrial septostomy.
- Patients who have an abnormality in the Echocardiogram or in the 12-lead ECG that, in the opinion of the Investigator, increases the risk of participating in the study.
- Pulmonary function test (PFT) values of forced vital capacity (FVC) and or FEV1 < 60% predicted at the screening visit or within 6 months prior to the screening visit.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Phase 1b, Multicenter, Open-Label, Multiple Ascending Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS135 Added to Background Pulmonary Arterial Hypertension (PAH) Therapy
A Study of HS135 for the Treatment of Pulmonary Arterial Hypertension in Adults
Read the detailed description
Phase 1b, Multicenter, Open-Label, Multiple Ascending Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS135 Added to Background Pulmonary Arterial Hypertension (PAH) Therapy
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Being tested
- HS135
- 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.
HS135Biological
HS135 is dosed subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| HS135 | Experimental | Subcutaneous Injection Receives: Biological: HS135 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
Measured: Up to 24 weeks
Change from Baseline in Physical Examination
Physical Examination will include the assessment of body systems.
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters
Measured: Up to 24 weeks
Change from Baseline in Blood Pressure
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start23 Oct 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Why it stopped: Sponsor's Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial Hypertension (PAH)Studies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- 35Pharma Inc., a GSK company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Monique Champagne, M.Sc., Study director, VP, Clinical Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493461
- Sponsor's protocol ID
- HS135-002
- Status last verified
- May 2025
- First submitted
- 28 Jun 2024
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b, Multicenter, Open-Label, Multiple Ascending Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS135 Added to Background Pulmonary Arterial Hypertension (PAH) Therapy
- ClinicalTrials.gov ID
- NCT06493461
- Acronym / sponsor ID
- HS135-002
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's Decision
- Enrolment
- 5 participants (actual)
- Lead sponsor
- 35Pharma Inc., a GSK companyIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 10 Jul 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 of HS135 for the Treatment of Pulmonary Arterial Hypertension in Adults
Detailed description
Phase 1b, Multicenter, Open-Label, Multiple Ascending Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS135 Added to Background Pulmonary Arterial Hypertension (PAH) Therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS135 | Experimental | Biological: HS135Subcutaneous Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female patients, 18 years of age and older.
- Body Mass Index (BMI) 18.5 and 40 kg/m2 and body weight at or below 120 kg
- Documented diagnostic RHC at any time prior to screening.
- Diagnosis of WHO PAH Group 1.
- Symptomatic PAH classified as WHO FC II to IV.
Key exclusion criteria (7 listed)
- Left ventricular ejection fraction < 50% at screening.
- Any symptomatic coronary disease events within 6 months of the screening visit.
- Uncontrolled systemic hypertension.
- History of restrictive, constrictive or congestive cardiomyopathy.
- History of atrial septostomy.
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 |
|---|---|---|
| HS135HS135 is dosed subcutaneously | Biological | HS135 |
Primary outcome
Adverse Events (AEs)
Time frame: Up to 24 weeks
Change from Baseline in Physical Examination
Time frame: Up to 24 weeks
Physical Examination will include the assessment of body systems.
Change from Baseline in Clinical Laboratory Parameters
Time frame: Up to 24 weeks
Change from Baseline in Blood Pressure
Time frame: Up to 24 weeks
Results and safety
The study was stopped early (reason given: Sponsor's Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
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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. This study is not recruiting at the moment.
Monique Champagne, M.Sc. study director
VP, Clinical Operations
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS135 in people with Pulmonary Arterial Hypertension (PAH), run by 35Pharma Inc., a GSK company at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. 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: stopped early, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor's Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) (time frame: Up to 24 weeks). The study lists 4 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 30 May 2025.