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Resistant HypertensionPhase 1DTC/RHSNCT05247528

Safety And Tolerability Of Subcutaneous MANP In Difficult To Control/Resistant Hypertensive Subjects

A Phase 1 study testing MANP in people with Resistant Hypertension and Difficult to Control Hypertension, run by E-Star BioTech, LLC at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A randomized, double-blind, placebo-controlled multiple ascending dose study in hypertensive subjects on stable doses of at least three hypertensive drugs for at least 6 weeks prior to Screening. The study will consist of screening, PK-unit admittance, and safety follow up periods. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
MANP
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
37 participants
Where
5 sitesUnited States
Study dates
20 Dec 2021to 31 Oct 2022
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • DTC/RH diagnosed with clinic SBP ≥140 mmHg or DBP ≥ 90 mmHg (or SBP ≥ 130 mmHg or DBP ≥ 80 mmHg for diabetics) while on at least three standard-of-care antihypertensive medications (which must include a diuretic).
  • MDRD eGFR ≥ 30 mL/min.
  • Men and women between the ages of 18 - 80.
  • BMI within the range of 18-40 kg/m2.
  • Women of childbearing potential must not be pregnant and agree to avoid becoming pregnant while receiving study treatment and for 14 days after the last study visit.

Who cannot join

  • HbA1c ≥ 8% at Screening.
  • Use of other investigational drugs within 30 days of screening or foreseen use during the study.
  • Inability to comply with study requirements as judged by the Investigator.
  • Pregnant and/or breastfeeding.
  • Any disease or condition (medical or surgical) which, in the opinion of the investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • USA Clinical Site 03

    Anniston, Alabama, 36207

  • USA Clinical Site 04

    Decatur, Georgia, 30030

  • USA Clinical Site 02

    DeLand, Florida, 32738

  • USA Clinical Site 05

    Owensboro, Kentucky, 42303

  • USA Clinical Site 01

    Tustin, California, 92780

Other trials in United States

About this study

Official title: A Phase 1B, Multiple Ascending Dose Trial Examining The Safety And Tolerability Of Subcutaneous MANP In Difficult To Control/Resistant Hypertensive Subjects

A randomized, double-blind, placebo-controlled multiple ascending dose study in hypertensive subjects on stable doses of at least three hypertensive drugs for at least 6 weeks prior to Screening. The study will consist of screening, PK-unit admittance, and safety follow up periods.

Subjects will be randomized at a 6:2 ratio of either MANP or placebo and will be stratified by race in each dosage cohort. The entire first Cohort will be given the lowest dosage with subsequent cohorts progressing sequentially to the higher doses depending on safety and tolerability of the previous cohort.

Endpoints not related to the safety reviews will be analyzed after the last patient last visit (LPLV).

Being tested
MANP, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MANPDrug

    Novel designer peptide to represent a pGC-A/cGMP therapeutic

  • PlaceboDrug

    Placebo Comparator

Study groups in NCT05247528
Study groupRoleWhat they receive
Placebo ComparatorPlacebo comparator* Subjects randomized to the placebo arm, will receive a single subcutaneous injection each morning daily. * Intervention: Placebo
Receives: Drug: Placebo
MANPExperimental* Subjects randomized to the experimental arm, will receive a single subcutaneous injection each morning daily. (multiple ascending dose cohorts) * Intervention: Drug: MANP
Receives: Drug: MANP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

    Number and percent of participants with one or more Treatment Emergent Adverse Events (TEAEs) or any serious adverse events (SAEs).

    Measured: through study completion, an average of 2 months.

  2. Blood Pressure

    Change in SBP and DBP

    Measured: From baseline to Days 1-6, Day 12, and 21.

  3. Hematology Hematocrit

    Change in Percent Hematocrit

    Measured: From baseline to Day 21.

  4. Physical Examination: Body Parts

    Change in investigator assessment of the condition of body parts (head, throat, abdomen, and extremities)

    Measured: From baseline to Day 21

  5. ECG: QT interval

    Change in 12-Lead ECG QT Interval

    Measured: From baseline to Days 1-6 and Day 21.

  6. Temperature

    Change in Temperature

    Measured: From baseline to Days 1-6, Day 12, and 21.

  7. Pulse Rate

    Change in Pulse Rate

    Measured: From baseline to Days 1-6, Day 12, and 21.

  8. Hematology: Hemoglobin

    Change in g/dL Hemoglobin

    Measured: From baseline to Day 21

  9. Hematology: Mean Corpuscular Hemoglobin

    Change in the mean corpuscular hemoglobin.

    Measured: From baseline to Day 21

  10. Hematology: Platelets

    Change in platelet count

    Measured: From baseline to Day 21

  11. Hematology: RBC distribution

    Change in red blood cell distribution width

    Measured: From baseline to Day 21

  12. Hematology: RBC

    Change in red blood cell count

    Measured: From baseline to Day 21

  13. Hematology: WBC

    Change in white blood cell count

    Measured: From baseline to Day 21

  14. Chemistry: Sodium

    Change in Sodium concentration.

    Measured: From baseline to Day 21

  15. Chemistry: Potassium

    Change in Potassium concentration.

    Measured: From baseline to Day 21

  16. Chemistry: Chloride

    Change in Chloride concentration

    Measured: From baseline to Day 21

  17. Chemistry: Bicarbonate

    Change in Bicarbonate concentration

    Measured: From baseline to Day 21

  18. Chemistry: Alanine aminotransferase

    Change in ALT (IU/L)

    Measured: From baseline to Day 21

  19. Chemistry: Aspartate aminotransferase

    Change in AST (IU/L)

    Measured: From baseline to Day 21

  20. Chemistry: Alkaline phosphatase

    Change in Alkaline phosphatase (IU/L)

    Measured: From baseline to Day 21

  21. Chemistry: Bilirubin

    Change in Total bilirubin (mg/dL)

    Measured: From baseline to Day 21

  22. Chemistry: Blood urea nitrogen

    Change in BUN (mg/dL)

    Measured: From baseline to Day 21

  23. Chemistry: Creatinine

    Change in Creatinine (mg/dL)

    Measured: From baseline to Day 21

  24. Chemistry: Glucose

    Change in Glucose (mg/dL)

    Measured: From baseline to Day 21

  25. Chemistry: HbA1c

    Change in percent HbA1c

    Measured: From baseline to Day 21

  26. Physical Examination: Organs

    Change in investigator assessment of the condition of organs (skin, eyes, ears, nose, thyroid, lungs, liver, spleen, and lymph nodes)

    Measured: From baseline to Day 21

  27. Abbreviated Neurological Examination

    Change in investigator assessment of neurological condition

    Measured: From baseline to Day 21

  28. ECG: QTc interval

    Change in 12-Lead ECG QTc (Fridericia's) Interval

    Measured: From baseline to Days 1-6 and Day 21

Secondary outcomes (11)

  1. Cardiac Metrics: Blood pressures

    Change in SBP and DBP

    Measured: From Baseline for Day 1-6

  2. Serum creatinine

    Change in Serum creatinine

    Measured: From Baseline for Day 1-6

  3. MANP

    Change in amount of Plasma MANP both in plasma.

    Measured: From baseline for Day 1 & Day 5

  4. Immune Response

    Change in amount of anti-MANP and anti-ANP

    Measured: From baseline for Day 1, Day 5, Day 12, & Day 21

  5. Metabolics

    Change in amount of non-esterified insulin and glucose.

    Measured: From baseline for Day 1 & Day 5

  6. eGFR,

    Change in eGFR,

    Measured: From Baseline for Day 1-6

  7. Urine flow rate

    Change in urine flow rate

    Measured: From Baseline for Day 1-6

  8. Urinary Sodium Excretion

    Change in amount of urinary sodium excretion

    Measured: From Baseline for Day 1-6

  9. cGMP

    Change in amount of cGMP both in plasma and urine

    Measured: from baseline for Day 1 & Day 5

  10. Aldosterone

    Change in amount of aldosterone both in plasma and urine

    Measured: from baseline for Day 1 & Day 5

  11. Cardiac Metrics:

    Heart Rate

    Measured: From Baseline for Day 1-6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2022
  2. Study start20 Dec 2021
  3. Primary completion31 Oct 2022
  4. Study completion31 Oct 2022

Resources

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05247528
Sponsor's protocol ID
ES_MANP_21-01
Acronym
DTC/RHS
Status last verified
Nov 2022
First submitted
22 Dec 2021
Last updated
29 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MANP in people with Resistant Hypertension and Difficult to Control Hypertension, run by E-Star BioTech, LLC at 5 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 5 inclusion and 5 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 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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. 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 (time frame: through study completion, an average of 2 months.). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05247528.

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 29 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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