HealthyPhase 1NCT06930664
A Study of Sotatercept (MK-7962) in Healthy Females Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation (MK-7962-027)
A Phase 1 study testing Sotatercept and Sotatercept Autoinjector in people with Healthy, run by Merck Sharp & Dohme LLC at 4 sites in United States.
Trial summary
The goal of the study is to learn what happens to different forms of sotatercept medications in a healthy person's body over time. Researchers want to know if there is a difference in the healthy person's body when different forms of sotatercept medications are given. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sotatercept and Sotatercept Autoinjector
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 May 2025to 25 Nov 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 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The key inclusion criteria include but are not limited to the following:
- Is in good health before randomization
- Has a body weight between 75 and 100 kg, inclusive
- Is assigned female sex at birth and is a participant of nonchildbearing potential (PONCBP) defined as one of the following:
- Premenarchal
- Premenopausal with documented hysterectomy and/or bilateral salpingectomy
- Postmenopausal
- Medical cause of permanent infertility (eg, Müllerian agenesis, androgen insensitivity)
Who cannot join
- The key exclusion criteria include but are not limited to the following:
- Has a history of opportunistic infection (eg, invasive candidiasis or pneumocystis pneumonia)
- Has had a serious local infection (eg, cellulitis, abscess) or systemic infection (eg, septicemia) within 3 months prior to screening
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Anaheim Clinical Trials ( Site 0007)
Anaheim, California, 92801
Advanced Pharma CR, LLC ( Site 0005)
Miami, Florida, 33147
QPS-MRA, LLC ( Site 0004)
South Miami, Florida, 33143
Bio-Kinetic Clinical Applications, LLD dba QPS-MO ( Site 0003)
Springfield, Missouri, 65802
About this study
Official title: A Phase 1 Clinical Study in Healthy Females of Nonchildbearing Potential to Compare the Pharmacokinetics of Sotatercept (MK-7962) Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation
The goal of the study is to learn what happens to different forms of sotatercept medications in a healthy person's body over time. Researchers want to know if there is a difference in the healthy person's body when different forms of sotatercept medications are given.
- Conditions
- Healthy
- Being tested
- Sotatercept, Sotatercept Autoinjector
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotaterceptBiological
Also called MK-7962, ActRIIA-IgG1Fc, ACE-011
Subcutaneous Injection
Sotatercept AutoinjectorBiological
Also called MK-7962, ActRIIA-IgGIFc, ACE-011
Subcutaneous Auto Injection
| Study group | Role | What they receive |
|---|---|---|
| High Dose Subcutaneous Injection | Active comparator | Participants will receive a single subcutaneous high dose of sotatercept administered via syringe. Receives: Biological: Sotatercept |
| High Dose Subcutaneous Autoinjector | Experimental | Participants will receive a single subcutaneous high dose of sotatercept administered via autoinjector. Receives: Biological: Sotatercept Autoinjector |
| Low Dose Subcutaneous Autoinjector | Experimental | Participants will receive a single subcutaneous low dose of sotatercept administered via autoinjector. Receives: Biological: Sotatercept Autoinjector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Sotatercept at High Dose
Blood samples will be collected to determine the AUC0-inf of sotatercept in plasma.
Measured: Predose and at designated timepoints (up to approximately 120 days postdose)
Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Sotatercept at High Dose
Blood samples will be collected to determine the AUC0-last of sotatercept in plasma.
Measured: Predose and at designated timepoints (up to approximately 120 days postdose
Maximum Observed Concentration (Cmax) of Sotatercept at High Dose
Blood samples will be collected to determine the Cmax of sotatercept in plasma.
Measured: Predose and at designated timepoints (up to approximately 120 days postdose
Secondary outcomes (13)
Time of the Maximum Observed Concentration (Tmax) of Sotatercept High Dose
Blood samples will be collected to determine the Tmax of sotatercept in plasma.
Measured: Predose and at designated timepoints (up to approximately 120 days postdose
Apparent Terminal Elimination Half-Life (t1/2) of Sotatercept at High Dose
Blood samples will be collected to determine the t1/2 of sotatercept in plasma.
Measured: Predose and at designated timepoints (up to approximately 120 days postdose
Apparent Total Plasma Clearance (CL/F) of Sotatercept at High Dose
Blood samples will be collected to determine the CL/F of sotatercept in plasma.
Measured: Predose and at designated timepoints (up to approximately 120 days postdose
Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F) of Sotatercept at High Dose
Blood samples will be collected to determine the Vz/F of sotatercept in plasma.
Measured: Predose and at designated timepoints (up to approximately 120 days postdose
Cmax of Sotatercept Low Dose
Blood samples will be collected to determine the Cmax of sotatercept in plasma.
Measured: Predose and at designated timepoints (up to approximately 120 days postdose
Tmax of Sotatercept at Low Dose
Blood samples will be collected to determine the Tmax of sotatercept in plasma.
Measured: Predose and at designated timepoints (up to approximately 120 days postdose
AUC0-inf of Sotatercept at Low Dose
Blood samples will be collected to determine the AUC0-inf of sotatercept in plasma.
Measured: Predose and at designated timepoints (up to approximately 120 days postdose
AUC0-last of Sotatercept at Low Dose
Blood samples will be collected to determine the AUC0-last of sotatercept in plasma.
Measured: Predose and at designated timepoints (up to approximately 120 days postdose
t1/2 of Sotatercept at Low Dose
Blood samples will be collected to determine the t1/2 of sotatercept in plasma.
Measured: Predose and at designated timepoints (up to approximately 120 days postdose
CL/F of Sotatercept at Low Dose
Blood samples will be collected to determine the CL/F of sotatercept in plasma.
Measured: Predose and at designated timepoints (up to approximately 120 days postdose
Vz/F of Sotatercept at Low Dose
Blood samples will be collected to determine the Vz/F of sotatercept in plasma.
Measured: Predose and at designated timepoints (up to approximately 120 days postdose
Number of Participants who Experienced an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Measured: Up to approximately 120 days
Number of Participants who Discontinued the Study Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Measured: Up to approximately 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start16 May 2025
- Primary completion11 Nov 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930664
- Sponsor's protocol ID
- 7962-027
- Other IDs
- MK-7962-027
- Status last verified
- Dec 2025
- First submitted
- 9 Apr 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study in Healthy Females of Nonchildbearing Potential to Compare the Pharmacokinetics of Sotatercept (MK-7962) Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation
- ClinicalTrials.gov ID
- NCT06930664
- Acronym / sponsor ID
- 7962-027
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 16 May 2025 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 16 Apr 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.
The goal of the study is to learn what happens to different forms of sotatercept medications in a healthy person's body over time. Researchers want to know if there is a difference in the healthy person's body when different forms of sotatercept medications are given.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Dose Subcutaneous Injection | Active comparator | Biological: SotaterceptParticipants will receive a single subcutaneous high dose of sotatercept administered via syringe. |
| High Dose Subcutaneous Autoinjector | Experimental | Biological: Sotatercept AutoinjectorParticipants will receive a single subcutaneous high dose of sotatercept administered via autoinjector. |
| Low Dose Subcutaneous Autoinjector | Experimental | Biological: Sotatercept AutoinjectorParticipants will receive a single subcutaneous low dose of sotatercept administered via autoinjector. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Is in good health before randomization
- Has a body weight between 75 and 100 kg, inclusive
- Is assigned female sex at birth and is a participant of nonchildbearing potential (PONCBP) defined as one of the following:
Key exclusion criteria (3 listed)
- Has a history of opportunistic infection (eg, invasive candidiasis or pneumocystis pneumonia)
- Has had a serious local infection (eg, cellulitis, abscess) or systemic infection (eg, septicemia) within 3 months prior to screening
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 |
|---|---|---|
| SotaterceptAlso: MK-7962, ActRIIA-IgG1Fc, ACE-011Subcutaneous Injection | Biological | High Dose Subcutaneous Injection |
| Sotatercept AutoinjectorAlso: MK-7962, ActRIIA-IgGIFc, ACE-011Subcutaneous Auto Injection | Biological | High Dose Subcutaneous Autoinjector, Low Dose Subcutaneous Autoinjector |
Primary outcome
Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Sotatercept at High Dose
Time frame: Predose and at designated timepoints (up to approximately 120 days postdose)
Blood samples will be collected to determine the AUC0-inf of sotatercept in plasma.
Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Sotatercept at High Dose
Time frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the AUC0-last of sotatercept in plasma.
Maximum Observed Concentration (Cmax) of Sotatercept at High Dose
Time frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the Cmax of sotatercept in plasma.
13 secondary outcomes
Time of the Maximum Observed Concentration (Tmax) of Sotatercept High Dose
Time frame: Predose and at designated timepoints (up to approximately 120 days postdose
Apparent Terminal Elimination Half-Life (t1/2) of Sotatercept at High Dose
Time frame: Predose and at designated timepoints (up to approximately 120 days postdose
Apparent Total Plasma Clearance (CL/F) of Sotatercept at High Dose
Time frame: Predose and at designated timepoints (up to approximately 120 days postdose
Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F) of Sotatercept at High Dose
Time frame: Predose and at designated timepoints (up to approximately 120 days postdose
Cmax of Sotatercept Low Dose
Time frame: Predose and at designated timepoints (up to approximately 120 days postdose
Tmax of Sotatercept at Low Dose
Time frame: Predose and at designated timepoints (up to approximately 120 days postdose
AUC0-inf of Sotatercept at Low Dose
Time frame: Predose and at designated timepoints (up to approximately 120 days postdose
AUC0-last of Sotatercept at Low Dose
Time frame: Predose and at designated timepoints (up to approximately 120 days postdose
t1/2 of Sotatercept at Low Dose
Time frame: Predose and at designated timepoints (up to approximately 120 days postdose
CL/F of Sotatercept at Low Dose
Time frame: Predose and at designated timepoints (up to approximately 120 days postdose
Vz/F of Sotatercept at Low Dose
Time frame: Predose and at designated timepoints (up to approximately 120 days postdose
Number of Participants who Experienced an Adverse Event (AE)
Time frame: Up to approximately 120 days
Number of Participants who Discontinued the Study Due to an AE
Time frame: Up to approximately 120 days
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 15 Dec 2025.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sotatercept and Sotatercept Autoinjector in people with Healthy, run by Merck Sharp & Dohme LLC at 4 sites 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 8 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 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Sotatercept at High Dose (time frame: Predose and at designated timepoints (up to approximately 120 days postdose)). 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 15 Dec 2025.