HV Study to Assess Normal Range of C4 and C1-INH (QCL118059)

• Research type

  Research Study

• Full title

  Assessment of the Normal Range of C4 and C1-INH Functional Levels in Healthy Volunteers

• IRAS ID

  233358

• Contact name

  Phil Collis PhD

• Contact email

  pcollis@biocryst.com

• Sponsor organisation

  BioCryst Pharmaceuticals, Inc.

• Duration of Study in the UK

  0 years, 2 months, 3 days

• Research summary

  Research Summary
  The Sponsor is developing treatments for hereditary angioedema (HAE). HAE is a potentially life threatening disease characterised by swelling of the skin, throat, gut, genitals and extremities (hands and feet). One of the causes of HAE is a less than normal amount of a particular protein in the blood, which causes the mentioned swelling. The sponsor wishes to better characterise the normal ranges of this protein in healthy people as well as understand how to handle and process blood samples correctly so as not to damage this protein when diagnosing HAE. They will also be looking at other relevant blood properties necessary to detect HAE.

  The objective of the study is to better characterise the normal range of blood factors C1-INH and C4 in the blood of healthy volunteers.

  Volunteers recruited from the Quotient Sciences volunteer panel will be invited to take part in the study, where they will be required to donate a venous blood sample on a single occasion. They will be given a participant information sheet and informed consent form, which they will sign before enrolling into the study. Before their blood draw, the study team will confirm the volunteer’s eligibility by asking a series of questions in regards to their medical history and female subjects will undergo a urine pregnancy test. The anonymity of the volunteers to the Sponsor will be assured at all times.

  The blood samples will be transported to the bioanalytical laboratory in the USA where they will be analysed. Samples or derivatives of the samples may be stored for up to 15 years.

  Summary of Results
  Given that this is a non-CTIM study, no lay summary of results has been provided for reasons of commercial confidentiality. The objective of the study was characterization of normal plasma levels of 2 complement related proteins in healthy volunteers.

• REC name

  HSC REC A

• REC reference

  18/NI/0012

• Date of REC Opinion

  19 Feb 2018

• REC opinion

  Further Information Favourable Opinion