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OpenTrials
Completed

NCT Number: NCT05291546

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9035 in Healthy Adult Volunteers and Mildly Hypertensive Participants

The primary objective of the study is to:

• Evaluate the safety and tolerability of REGN5381 and REGN9035 administered alone or sequentially.

The secondary objectives of the study are to:

* Evaluate the ability of single intravenous (IV) doses of REGN9035 (compared to placebo) to reverse the acute hemodynamic effects of REGN5381 * Evaluate the hemodynamic effects of single IV doses of REGN5381 * Evaluate the persistence of the hemodynamic effects of single IV doses of REGN5381 and the reversal of REGN5381 effects by REGN9035 (compared to placebo) * Evaluate the pharmacokinetics of single IV doses of REGN5381 and REGN9035 administered alone or sequentially

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Key information

Conditions

Healthy Volunteers Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Universitair Ziekenhuis Leuven Gasthuisberg Campus, Leuven, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Body mass index (BMI) between 18 and 32 kg/m2, inclusive, at the screening visit.
  • Normal or mildly elevated blood pressure as defined in the protocol.

Key Exclusion Criteria:

  • History of unexplained syncope or autonomic dysfunction.
  • History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease.
  • Protocol-defined risk factors for cardiovascular disease.

Note: Other protocol defined inclusion / exclusion criteria apply

Treatment and study plan

REGN9035

Drug

Part A: Single dose administered by IV infusion on day 1. Part B: Selected doses administered by IV infusion on day 2 or 22.

REGN5381

Drug

Part B: Selected doses administered by IV infusion on day 1.

Placebo

Other

Part A: Single dose administered by IV infusion on day1. Part B: Single dose administered by IV infusion on day 1, day 2 and/or day 22.

Primary outcomes

  1. Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to Day 162

Secondary outcomes

  1. Mean systolic blood pressure (SBP) obtained after study drug administration

    Time frame: Up to Day 3

    Up to 24 hours after study drug administration.

  2. Mean diastolic blood pressure (DBP) obtained after study drug administration

    Time frame: Up to Day 3

  3. Mean arterial pressure (MAP) obtained after study drug administration

    Time frame: Up to Day 3

  4. Mean pulse pressure (PP) obtained after study drug administration

    Time frame: Up to Day 3

  5. Mean pulse rate (PR) obtained after study drug administration

    Time frame: Up to Day 3

  6. Mean stroke volume (SV) obtained after study drug administration

    Time frame: Up to Day 3

  7. Absolute change in the mean SBP obtained after study drug administration

    Time frame: Up to Day 3

  8. Absolute change in the mean DBP obtained after study drug administration

    Time frame: Up to Day 3

  9. Absolute change in the mean MAP obtained after study drug administration

    Time frame: Up to Day 3

  10. Absolute change in the mean PP obtained after study drug administration

    Time frame: Up to Day 3

  11. Absolute change in the mean PR obtained after study drug administration

    Time frame: Up to Day 3

  12. Absolute change in the mean SV obtained after study drug administration

    Time frame: Up to Day 3

  13. Maximum change in the mean SBP obtained after study drug administration

    Time frame: Up to Day 3

  14. Maximum change in the mean DBP obtained after study drug administration

    Time frame: Up to Day 3

  15. Maximum change in the mean MAP obtained after study drug administration

    Time frame: Up to Day 3

  16. Maximum change in the mean PP obtained after study drug administration

    Time frame: Up to Day 3

  17. Maximum change in the mean PR obtained after study drug administration

    Time frame: Up to Day 3

  18. Maximum change in the mean SV obtained after study drug administration

    Time frame: Up to Day 3

  19. Percent change in the mean SBP obtained after study drug administration

    Time frame: Up to Day 3

  20. Percent change in the mean DBP obtained after study drug administration

    Time frame: Up to Day 3

  21. Percent change in the mean MAP obtained after study drug administration

    Time frame: Up to Day 3

  22. Percent change in the mean PP obtained after study drug administration

    Time frame: Up to Day 3

  23. Percent change in the mean PR obtained after study drug administration

    Time frame: Up to Day 3

  24. Percent change in the mean SV obtained after study drug administration

    Time frame: Up to Day 3

  25. Absolute change from baseline (post-REGN5381 administration) in the mean SBP obtained after study drug administration

    Time frame: Up to Day 3

  26. Absolute change from baseline (post-REGN5381 administration) in the mean DBP obtained after study drug administration

    Time frame: Up to Day 3

  27. Absolute change from baseline (post-REGN5381 administration) in the mean MAP obtained after study drug administration

    Time frame: Up to Day 3

  28. Absolute change from baseline (post-REGN5381 administration) in the mean PP obtained after study drug administration

    Time frame: Up to Day 3

  29. Absolute change from baseline (post-REGN5381 administration) in the mean PR obtained after study drug administration

    Time frame: Up to Day 3

  30. Absolute change from baseline (post-REGN5381 administration) in the mean SV obtained after study drug administration

    Time frame: Up to Day 3

  31. Maximum change from baseline (post-REGN administration) in the mean SBP obtained after study drug administration

    Time frame: Up to Day 3

  32. Maximum change from baseline (post-REGN administration) in the mean DBP obtained after study drug administration

    Time frame: Up to Day 3

  33. Maximum change from baseline (post-REGN administration) in the mean MAP obtained after study drug administration

    Time frame: Up to Day 3

  34. Maximum change from baseline (post-REGN administration) in the mean PP obtained after study drug administration

    Time frame: Up to Day 3

  35. Maximum change from baseline (post-REN5381 administration) in the mean PR obtained after study drug administration

    Time frame: Up to Day 3

  36. Maximum change from baseline (post-REGN5381 administration) in the mean SV obtained after study drug administration

    Time frame: Up to Day 3

  37. Percent change from baseline (post-REN5381 administration) in the mean SBP obtained after study drug administration

    Time frame: Up to Day 3

  38. Percent change from baseline (post-REN5381 administration) in the mean DBP obtained after study drug administration

    Time frame: Up to Day 3

  39. Percent change from baseline (post-REN5381 administration) in the mean MAP obtained after study drug administration

    Time frame: Up to Day 3

  40. Percent change from baseline (post-REN5381 administration) in the mean PP obtained after study drug administration

    Time frame: Up to Day 3

  41. Percent change from baseline (post-REN5381 administration) in the mean PR obtained after study drug administration

    Time frame: Up to Day 3

  42. Percent change from baseline (post-REN5381 administration) in the mean SV obtained after study drug administration

    Time frame: Up to Day 3

  43. Absolute change from baseline (pre-REGN5381 administration) in the mean SBP obtained after study drug administration

    Time frame: Up to Day 3

  44. Absolute change from baseline (pre-REGN5381 administration) in the mean DBP obtained after study drug administration

    Time frame: Up to Day 3

  45. Absolute change from baseline (pre-REGN5381 administration) in the mean MAP obtained after study drug administration

    Time frame: Up to Day 3

  46. Absolute change from baseline (pre-REGN5381 administration) in the mean PP obtained after study drug administration

    Time frame: Up to Day 3

  47. Absolute change from baseline (pre-REGN5381 administration) in the mean PR obtained after study drug administration

    Time frame: Up to Day 3

  48. Absolute change from baseline (pre-REGN5381 administration) in the mean SV obtained after study drug administration

    Time frame: Up to Day 3

  49. Maximum change from baseline (pre-REGN administration) in the mean SBP obtained after study drug administration

    Time frame: Up to Day 3

  50. Maximum change from baseline (pre-REGN administration) in the mean DBP obtained after study drug administration

    Time frame: Up to Day 3

  51. Maximum change from baseline (pre-REGN administration) in the mean MAP obtained after study drug administration

    Time frame: Up to Day 3

  52. Maximum change from baseline (pre-REGN administration) in the mean PP obtained after study drug administration

    Time frame: Up to Day 3

  53. Maximum change from baseline (pre-REGN administration) in the mean PR obtained after study drug administration

    Time frame: Up to Day 3

  54. Maximum change from baseline (pre-REGN administration) in the mean SV obtained after study drug administration

    Time frame: Up to Day 3

  55. Percent change from baseline (pre-REN5381 administration) in the mean SBP obtained after study drug administration

    Time frame: Up to Day 3

  56. Percent change from baseline (pre-REN5381 administration) in the mean DBP obtained after study drug administration

    Time frame: Up to Day 3

  57. Percent change from baseline (pre-REN5381 administration) in the mean MAP obtained after study drug administration

    Time frame: Up to Day 3

  58. Percent change from baseline (pre-REN5381 administration) in the mean PP obtained after study drug administration

    Time frame: Up to Day 3

  59. Percent change from baseline (pre-REN5381 administration) in the mean PR obtained after study drug administration

    Time frame: Up to Day 3

  60. Percent change from baseline (pre-REN5381 administration) in the mean SV obtained after study drug administration

    Time frame: Up to Day 3

  61. Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) SBP obtained after study drug administration.

    Time frame: Baseline to Day 3

  62. Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) DBP obtained after study drug administration.

    Time frame: Baseline to Day 3

  63. Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) MAP obtained after study drug administration.

    Time frame: Baseline to Day 3

  64. Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) PP obtained after study drug administration.

    Time frame: Baseline to Day 3

  65. Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) PR obtained after study drug administration.

    Time frame: Baseline to Day 3

  66. Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) SV obtained after study drug administration.

    Time frame: Baseline to Day 3

  67. Time to return to within 10% of baseline (pre-REGN5381) SBP

    Time frame: Up to approximately Day 162

  68. Time to return to within 10% of baseline (pre-REGN5381) DBP

    Time frame: Up to approximately Day 162

  69. Time to return to within 10% of baseline (pre-REGN5381) MAP

    Time frame: Up to approximately Day 162

  70. Time to return to within 10% of baseline (pre-REGN5381) PP

    Time frame: Up to approximately Day 162

  71. Time to return to within 10% of baseline (pre-REGN5381) PR

    Time frame: Up to approximately Day 162

  72. Time to return to within 10% of baseline (pre-REGN5381) SV

    Time frame: Up to approximately Day 162

  73. SBP

    Time frame: Through Day 36

  74. DBP

    Time frame: Through Day 36

  75. MAP

    Time frame: Through Day 36

  76. PP

    Time frame: Through Day 36

  77. PR

    Time frame: Through Day 36

  78. Absolute change from baseline in SBP

    Time frame: Through Day 36

  79. Absolute change from baseline in DBP

    Time frame: Through Day 36

  80. Absolute change from baseline in MAP

    Time frame: Through Day 36

  81. Absolute change from baseline in PP

    Time frame: Through Day 36

  82. Absolute change from baseline in PR

    Time frame: Through Day 36

  83. Percent change from baseline in SBP

    Time frame: Through Day 36

  84. Percent change from baseline in DBP

    Time frame: Through Day 36

  85. Percent change from baseline in MAP

    Time frame: Through Day 36

  86. Percent change from baseline in PP

    Time frame: Through Day 36

  87. Percent change from baseline in PR

    Time frame: Through Day 36

  88. Concentrations of total REGN9035

    Time frame: Up to Day 162

  89. Concentrations of total REGN5381 over time

    Time frame: Up to Day 162

  90. Concentrations of total REGN9035 and/or total REGN5381

    Time frame: Up to Day 162

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9035 (an Anti-REGN5381 Antibody and Reversal Agent) and REGN5381 (an NPR1 Agonist Antibody) When Administered Alone or in Sequence to Healthy Volunteers and Mildly Hypertensive Subjects

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 22, 2022
Registry last updated
Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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