Healthy VolunteerPhase 1NCT07185321
A Phase 1 Study of Mosliciguat in Healthy, Adult Males
A Phase 1 study testing Mosliciguat, 14C mosliciguat and Dry Powder Inhaler in people with Healthy Volunteer, run by Pulmovant, Inc. at 1 site in United States.
Trial summary
This is a single-center, Phase 1, open-label, 3-period, fixed-sequence study to investigate the bioavailability, absorption, metabolism, excretion and the safety of mosliciguat administered to healthy male adults. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Mosliciguat, 14C mosliciguat and Dry Powder Inhaler
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2025to 13 Jul 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 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants willing and able to provide informed consent.
- Considered to be in good health by the Investigator, as determined by medical history, physical examination, vital sign measurements, 12 lead electrocardiogram (ECG), and laboratory test results.
Who cannot join
- History or presence of any condition (e.g., chronic diarrhea, urinary incontinence), or prior surgery (e.g., gastric bypass) that, in the opinion of the Investigator, poses a significant risk to participant safety and/or achievement of study objectives
- History or presence of COPD, moderate or persistent asthma, other chronic lung disease, or chronic respiratory condition within the last 5 years
- Acute or recent respiratory infection symptoms not resolved at least 3 days prior to Period 1 check-in.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Phase 1 Study to Investigate the Absolute Bioavailability and the Absorption, Metabolism, and Excretion of [14C]-Mosliciguat in Healthy, Adult Males
This is a single-center, Phase 1, open-label, 3-period, fixed-sequence study to investigate the bioavailability, absorption, metabolism, excretion and the safety of mosliciguat administered to healthy male adults.
- Conditions
- Healthy Volunteer
- Being tested
- Mosliciguat, 14C mosliciguat, Dry Powder Inhaler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MosliciguatDrug
Dose level for inhalation
14C mosliciguatDrug
Dose level
Dry Powder InhalerDevice
Dry powder inhaler for mosliciguat
| Study group | Role | What they receive |
|---|---|---|
| Mosliciguat (RVT-2301) | Experimental | Mosliciguat administered daily via dry powder inhaler. Receives: Drug: Mosliciguat; Device: Dry Powder Inhaler |
| 14C mosliciguat | Experimental | Administered orally and via IV Receives: Drug: 14C mosliciguat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the absolute bioavailability (ABA) of mosliciguat following administration of a single inhaled dose of mosliciguat followed by an IV microtracer dose of [14C]-mosliciguat in healthy adult males
Absolute bioavailability of inhaled mosliciguat
Measured: Baseline, Day 7
Area under the concentration-time curve (AUC) for mosliciguat
Measured: Baseline, Day 7
Assess the mass balance (i.e., cumulative excretion in urine and feces compared to the administered amount of radioactive isotope) of [14C] following a single oral dose of mosliciguat solution
Urine and fecal recovery of total [14C] radioactivity, [14C]-mosliciguat
Measured: Baseline, Day 28
Maximum observed concentration (Cmax)
Measured: Baseline, Day 7
Secondary outcomes (1)
Evaluate the incidence of Treatment-Emergent Adverse Events (safety and tolerability of mosliciguat)
Incidence, nature, and severity of participant TEAEs, SAEs, and AEs
Measured: Baseline, Day 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start10 Jun 2025
- Primary completion30 Jun 2025
- Study completion13 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmovant, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ubaldo Martin, Study director, Pulmovant, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185321
- Sponsor's protocol ID
- RVT-2301-106
- Status last verified
- Jun 2026
- First submitted
- 12 Sep 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase 1 Study to Investigate the Absolute Bioavailability and the Absorption, Metabolism, and Excretion of [14C]-Mosliciguat in Healthy, Adult Males
- ClinicalTrials.gov ID
- NCT07185321
- Acronym / sponsor ID
- RVT-2301-106
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Pulmovant, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 13 Jul 2025 (actual)
- First posted
- 22 Sep 2025 (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.
This is a single-center, Phase 1, open-label, 3-period, fixed-sequence study to investigate the bioavailability, absorption, metabolism, excretion and the safety of mosliciguat administered to healthy male adults.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mosliciguat (RVT-2301) | Experimental | Drug: Mosliciguat, Device: Dry Powder InhalerMosliciguat administered daily via dry powder inhaler. |
| 14C mosliciguat | Experimental | Drug: 14C mosliciguatAdministered orally and via IV |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants willing and able to provide informed consent.
- Considered to be in good health by the Investigator, as determined by medical history, physical examination, vital sign measurements, 12 lead electrocardiogram (ECG), and laboratory test results.
Key exclusion criteria (3 listed)
- History or presence of any condition (e.g., chronic diarrhea, urinary incontinence), or prior surgery (e.g., gastric bypass) that, in the opinion of the Investigator, poses a significant risk to participant safety and/or achievement of study objectives
- History or presence of COPD, moderate or persistent asthma, other chronic lung disease, or chronic respiratory condition within the last 5 years
- Acute or recent respiratory infection symptoms not resolved at least 3 days prior to Period 1 check-in.
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 |
|---|---|---|
| MosliciguatDose level for inhalation | Drug | Mosliciguat (RVT-2301) |
| 14C mosliciguatDose level | Drug | 14C mosliciguat |
| Dry Powder InhalerDry powder inhaler for mosliciguat | Device | Mosliciguat (RVT-2301) |
Primary outcome
Determine the absolute bioavailability (ABA) of mosliciguat following administration of a single inhaled dose of mosliciguat followed by an IV microtracer dose of [14C]-mosliciguat in healthy adult males
Time frame: Baseline, Day 7
Absolute bioavailability of inhaled mosliciguat
Area under the concentration-time curve (AUC) for mosliciguat
Time frame: Baseline, Day 7
Assess the mass balance (i.e., cumulative excretion in urine and feces compared to the administered amount of radioactive isotope) of [14C] following a single oral dose of mosliciguat solution
Time frame: Baseline, Day 28
Urine and fecal recovery of total [14C] radioactivity, [14C]-mosliciguat
Maximum observed concentration (Cmax)
Time frame: Baseline, Day 7
1 secondary outcome
Evaluate the incidence of Treatment-Emergent Adverse Events (safety and tolerability of mosliciguat)
Time frame: Baseline, Day 44
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Ubaldo Martin study director
Pulmovant, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mosliciguat, 14C mosliciguat and Dry Powder Inhaler in people with Healthy Volunteer, run by Pulmovant, Inc. at 1 site in United States.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine the absolute bioavailability (ABA) of mosliciguat following administration of a single inhaled dose of mosliciguat followed by an IV microtracer dose of [14C]-mosliciguat in healthy adult males (time frame: Baseline, Day 7). 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 16 Jun 2026.