ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 37 for:    "Hereditary angioedema" | United States

Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Recombinant Human C1 Esterase Inhibitor in Healthy Adult Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02663687
Recruitment Status : Completed
First Posted : January 26, 2016
Last Update Posted : December 12, 2016
Sponsor:
Information provided by (Responsible Party):
Shire

Brief Summary:
This trial is looking to gain information about the safety and tolerability of an investigational treatment (SHP623) in healthy adult volunteers. This study will also collect pharmacokinetic data (how the body absorbs and breaks down the study drug).

Condition or disease Intervention/treatment Phase
Hereditary Angioedema (HAE) Drug: Recombinant human C1 esterase inhibitor Drug: Placebo Drug: SHP623 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Ascending Dose, Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single Intravenous and Subcutaneous Doses of Recombinant Human C1 Esterase Inhibitor in Healthy Adult Subjects
Study Start Date : April 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: Treatment 1- 4
Treatment A: 9 Subjects will receive dose level I of SHP623 intravenously (IV). B: 9 Subjects will receive dose level I of SHP623 subcutaneously(SC).
Drug: Recombinant human C1 esterase inhibitor
Subjects will receive escalating doses I-IV as both IV and SC injections
Other Name: SHP623
Drug: SHP623
SHP623
Placebo Comparator: Placebo
3 Subjects will receive placebo for each cohort
Drug: Placebo
Subjects will receive matching placebo
Drug: Placebo
Placebo



Primary Outcome Measures :
  1. Number of participants with treatment-emergent adverse events (TEAEs ) including SAEs [ Time Frame: Day -1 to day 28 per treatment period ]

Secondary Outcome Measures :
  1. Maximum concentration occurring at tmax (Cmax) of IV SHP623 [ Time Frame: Predose up to 648 hours ]
  2. Time to reach the maximum plasma concentration (Tmax) of IV SHP623 [ Time Frame: Predose up to 648 hours ]
  3. Terminal half-life (t ½) of IV SHP623 [ Time Frame: Predose up to 648 hours ]
  4. Area under the plasma concentration curve from time zero to infinity (AUC0-∞) of IV SHP623 [ Time Frame: Predose up to 648 hours ]
  5. Area under the plasma concentration curve from time zero to 168 hours postdose of IV SHP623 [ Time Frame: Predose up to 648 hours ]
  6. Area under the curve from the time of dosing to the last measurable concentration (AUClast) of IV SHP623 [ Time Frame: Predose up to 648 hours ]
  7. Total body clearance for intravascular administration (CL) of IV SHP623 [ Time Frame: Predose up to 648 hours ]
  8. Volume of distribution associated with the terminal slope (Vz) following IV administration of SHP623 [ Time Frame: Predose up to 648 hours ]
  9. Maximum concentration occurring at tmax (Cmax) of SC SHP623 [ Time Frame: Predose up to 648 hours ]
  10. Time to reach the maximum plasma concentration (Tmax) of SC SHP623 [ Time Frame: Predose up to 648 hours ]
  11. Terminal half-life (t ½) of SC SHP623 [ Time Frame: Predose up to 648 hours ]
  12. Area under the plasma concentration curve from time zero to infinity (AUC0-∞) of SC SHP623 [ Time Frame: Predose up to 648 hours ]
  13. Area under the plasma concentration curve from time zero to 168 hours postdose of SC SHP623 [ Time Frame: Predose up to 648 hours ]
  14. Area under the curve from the time of dosing to the last measurable concentration (AUClast) of SC SHP623 [ Time Frame: Predose up to 648 hours ]
  15. Total body clearance for extravascular administration divided by the fraction of dose absorbed CL/F (SC) of SC SHP623 adult [ Time Frame: Predose up to 648 hours ]
  16. Volume of distribution associated with the terminal slope following extravascular administration (Vz/F)divided by the fraction of dose absorbed of SHP623 [ Time Frame: Predose up to 648 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Must be considered healthy. Healthy status is defined by absence of evidence of any active or chronic disease
  2. Male, or non-pregnant, non-lactating female, who agrees to comply with any applicable contraceptive requirements of the protocol, or females of non-child-bearing potential.
  3. Body mass index between 18.0 and 30.0 kg/m2 inclusive with a body weight >50 kg (110 lbs.). This inclusion criterion will be assessed only at the first screening visit.
  4. Hemoglobin ≥12.0g/ld.

Exclusion Criteria:

  1. Have a history of allergic reaction to C1 INH products (e.g. C1 Inhibitor [Human], Berinert [C1 Estrace Inhibitor (Human)] and C1 estrace [recombinant]
  2. Known history of alcohol or other substance abuse within the last year.
  3. Donation of blood or blood products within 60 days prior to receiving investigational product.
  4. Current use of any medication except hormonal replacement therapy, hormonal contraceptives and occasional use of any over-the-counter non-steroidal anti-inflammatory drug (NSAID) or acetaminophen.
  5. Have a history of hypercoagulability or other predisposition to thrombotic events.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02663687


Locations
United States, Florida
Clinical Pharmacology of Miami
Miami, Florida, United States, 33014
Sponsors and Collaborators
Shire
Investigators
Study Director: Richard Finkelman, DDS, PhD Shire

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT02663687     History of Changes
Other Study ID Numbers: SHP623-100
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: December 12, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Angioedemas, Hereditary
Angioedema
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Genetic Diseases, Inborn
Complement C1s
Complement C1 Inhibitor Protein
Complement C1 Inactivator Proteins
Immunologic Factors
Physiological Effects of Drugs
Complement Inactivating Agents
Immunosuppressive Agents