HypertensionPhase 1NCT07884461
The First-in-Human Study of GW906 Injection
A Phase 1 study testing GW906 injection in people with Hypertension, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This study is a randomized, double-blind, placebo-controlled, single-dose, dose-escalation trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of GW906 in healthy subjects and subjects with mild hypertension, as well as to conduct an initial exploration of its clinical efficacy. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- GW906 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 29 Mar 2025to 24 Aug 2026
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-60 years (inclusive) at the time of signing the informed consent form, gender is not restricted.
- BMI 19.0-30.0 kg/m² (inclusive) and weight ≥50 kg during the screening period.
- No use of antihypertensive medications, including ACEIs, ARBs, CCBs, ARNIs, diuretics, etc., within 30 days prior to signing the informed consent form.
- Mean seated SBP measured by AOBP during the screening and baseline periods was 110-159 mmHg (inclusive) and DBP was 70-99 mmHg (inclusive).
- 12-lead electrocardiogram (ECG) results are normal or, according to the investigator, abnormalities are clinically insignificant, and QTcF was <450 ms for males and <470 ms for females.
- Before any procedure related to the study begins, the applicant voluntarily signs a written informed consent form, fully understands the purpose and significance of the study, and is willing to comply with the study protocol
Who cannot join
- Secondary hypertension.
- Orthostatic hypotension (defined as a decrease in SBP ≥20 mmHg or DBP ≥10 mmHg within 1 minute after standing from a supine position).
- History of syncope.
- Metabolic and cardiovascular diseases: ① Diabetes mellitus, or laboratory tests showing fasting blood glucose ≥7.0 mmol/L (126 mg/dL) or glycated hemoglobin (HbA1c) ≥6.5%; ② History of cardiovascular events (e.g., stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, hospitalization for heart failure) or clinically significant valvular heart disease; ③ Other conditions deemed by the investigators to potentially affect the trial or increase the risk to the participants.
- Liver or kidney dysfunction, psychiatric disorders, neurological disorders, tumors, hematological disorders, or other uncontrolled/serious conditions, which the investigator deems may affect trial conduct or increase participant risk.
- Clinically relevant medical history or comorbidities, which the investigator deems may affect trial compliance or data interpretation.
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- History of allergy to ≥2 drugs, or known allergy to oligonucleotides or N-acetylgalactosamine (GalNAc).
- History of subcutaneous injection intolerance, or significant abdominal scarring (e.g., due to surgery or burns), which may affect administration of the study drug or assessment of local tolerance.
- Underwent major surgery within 6 months prior to screening, or plans to undergo surgery during the study.
- Lost more than 10% of body weight within 6 months prior to screening, or plans to lose weight during the study.
- History of hospitalization or any clinically significant illness within 3 months prior to randomization, which the investigator deems may affect trial conduct or data interpretation.
- Physical examination and vital signs (excluding blood pressure) results during the screening period are deemed abnormal and clinically significant by the investigator.
- Laboratory test results during the screening period are deemed abnormal and clinically significant by the investigator, including but not limited to:
- Creatinine level exceeding the upper limit of normal (ULN), or eGFR <90 mL/min/1.73 m².
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), direct bilirubin, and total bilirubin ≥1.5 times the ULN, deemed abnormal and clinically significant by the investigator.
- Serum potassium >5 mmol/L.
- Positive results for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody screening during the screening period.
- Vaccinated within 8 weeks prior to screening, or planned to be vaccinated during the study.
- Individuals who have received the investigational drug or participated in or are currently participating in other clinical trials within 30 days or 5 half-lives (whichever is longer) prior to randomization.
- Individuals who have used, are currently using, or are expected to use, any herbal remedies, supplements, over-the-counter or prescription drugs that affect blood pressure, or other drugs or treatments that the investigator determines may affect the participant's blood pressure or the conduct of the trial within 30 days or 5 half-lives (whichever is longer) prior to administration.
- Women who are pregnant, breastfeeding, or plan to become pregnant during the study period and within one year after administration; women with a positive pregnancy test result at the screening or baseline period; or women of childbearing age who have had unprotected sex with their partner within 14 days prior to or during the screening period.
- The participants or their partners is unwilling to comply with contraceptive requirements (such as complete abstinence, condoms, IUDs, tubal ligation, or other non-pharmacological contraceptive methods) during the study period and within one year after administration.
- Plans to donate sperm or eggs during the study and for 1 year after dosing.
- Alcohol intake ≥14 units per week within 30 days prior to administration of the investigational drug (1 unit = 10g alcohol ≈ 360mL beer/150mL wine/ 45 mL of 40% alcohol-by-volume spirits); or unwillingness to comply with the alcohol restriction requirements during the study period (alcohol intake <14 units/week, abstinence from alcohol within 24 hours prior to each visit); or a positive breathalyzer test (if a positive breathalyzer test is due to social drinking, a retest may be conducted before D-2 at the investigator's discretion, and the retest result shall prevail).
- Smoking ≥5 cigarettes per day within 3 months prior to screening, or planning to smoke ≥5 cigarettes per day during the study period.
- Positive drug abuse screening (if a false positive is due to methodological reasons, or a positive result is due to drugs (such as influenza or cold medicine), a retest may be conducted before D-2 at the investigator's discretion, and the retest result shall prevail).
- Excessive daily consumption of tea, coffee, and/or caffeinated beverages (≥8 cups/day, 1 cup = 250 mL) within the 3 months prior to randomization, or intake of caffeinated (e.g., coffee, strong tea, cola, chocolate, etc.) or rich in xanthines (animal organs, sardines, soy products, etc.) foods or beverages within 48 hours prior to randomization.
- Receiving a blood transfusion within the 3 months prior to screening, or a total blood donation/loss ≥400 mL; or a total blood donation/loss ≥200 mL within 1 month prior to screening.
- Unwilling or unable to avoid strenuous exercise within 48 hours prior to each blood sample collection.
- Other circumstances deemed unsuitable for participation by the investigator (e.g., circumstances that may cause blood pressure fluctuations or affect the diurnal rhythm of blood pressure)
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GW906 Injection in Chinese Healthy Subjects and Subjects With Mild Hypertension
This study is a randomized, double-blind, placebo-controlled, single-dose, dose-escalation trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of GW906 in healthy subjects and subjects with mild hypertension, as well as to conduct an initial exploration of its clinical efficacy.
- Conditions
- Hypertension
- Being tested
- GW906 injection, Placebo
- Keywords
- GW906, single-dose-escalation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW906 injectionDrug
GW906 injection
PlaceboDrug
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| GW906 Group | Experimental | Not described Receives: Drug: GW906 injection |
| Placebo Group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AE) and serious adverse events (SAE)
Measured: Day 0 to Month 3
Secondary outcomes (1)
The change in serum angiotensinogen (AGT) levels compared to the baseline after administration
Measured: To Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start29 Mar 2025
- Primary completion24 Aug 2026
- Study completion24 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Shenzhen Salubris Pharmaceuticals Co., Ltd.The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884461
- Sponsor's protocol ID
- GW906-PI-1
- Other IDs
- CTR20251035
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GW906 Injection in Chinese Healthy Subjects and Subjects With Mild Hypertension
- ClinicalTrials.gov ID
- NCT07884461
- Acronym / sponsor ID
- GW906-PI-1
- Conditions
- Hypertension
- Keywords
- GW906, single-dose-escalation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2025 (actual)
- Primary completion
- 24 Aug 2026 (actual)
- Study completion
- 24 Aug 2026 (actual)
- First posted
- 20 Oct 2026 (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 study is a randomized, double-blind, placebo-controlled, single-dose, dose-escalation trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of GW906 in healthy subjects and subjects with mild hypertension, as well as to conduct an initial exploration of its clinical efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GW906 Group | Experimental | Drug: GW906 injection |
| Placebo Group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-60 years (inclusive) at the time of signing the informed consent form, gender is not restricted.
- BMI 19.0-30.0 kg/m² (inclusive) and weight ≥50 kg during the screening period.
- No use of antihypertensive medications, including ACEIs, ARBs, CCBs, ARNIs, diuretics, etc., within 30 days prior to signing the informed consent form.
- Mean seated SBP measured by AOBP during the screening and baseline periods was 110-159 mmHg (inclusive) and DBP was 70-99 mmHg (inclusive).
- 12-lead electrocardiogram (ECG) results are normal or, according to the investigator, abnormalities are clinically insignificant, and QTcF was <450 ms for males and <470 ms for females.
Key exclusion criteria (30 listed)
- Secondary hypertension.
- Orthostatic hypotension (defined as a decrease in SBP ≥20 mmHg or DBP ≥10 mmHg within 1 minute after standing from a supine position).
- History of syncope.
- Metabolic and cardiovascular diseases: ① Diabetes mellitus, or laboratory tests showing fasting blood glucose ≥7.0 mmol/L (126 mg/dL) or glycated hemoglobin (HbA1c) ≥6.5%; ② History of cardiovascular events (e.g., stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, hospitalization for heart failure) or clinically significant valvular heart disease; ③ Other conditions deemed by the investigators to potentially affect the trial or increase the risk to the participants.
- Liver or kidney dysfunction, psychiatric disorders, neurological disorders, tumors, hematological disorders, or other uncontrolled/serious conditions, which the investigator deems may affect trial conduct or increase participant risk.
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 |
|---|---|---|
| GW906 injectionGW906 injection | Drug | GW906 Group |
| PlaceboNormal saline | Drug | Placebo Group |
Primary outcome
Adverse events (AE) and serious adverse events (SAE)
Time frame: Day 0 to Month 3
1 secondary outcome
The change in serum angiotensinogen (AGT) levels compared to the baseline after administration
Time frame: To Month 3
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 20 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 GW906 injection in people with Hypertension, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
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 6 inclusion and 30 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 20 Oct 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 China. 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 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?
Adverse events (AE) and serious adverse events (SAE) (time frame: Day 0 to Month 3). 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 20 Oct 2026.