A Study of Subcutaneous KY1005 in Healthy Volunteers

  • STATUS
    Recruiting
  • participants needed
    24
  • sponsor
    Kymab Limited
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Updated on 19 February 2024
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Summary

Single centre, open-label, single dose, parallel group study to investigate the PK, safety and tolerability of KY1005 after subcutaneous (s.c.) and intravenous (i.v.) administration, with i.v. KY1005 as a reference treatment.

Details
Condition Disorder of immune system
Age 18years - 45years
Treatment KY1005
Clinical Study IdentifierNCT04449939
SponsorKymab Limited
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male, aged 18-45 years at screening
Body weight 60-120 kg
Body mass index (BMI) in the range 18.0-30.0 kg/m^2 (inclusive)
Deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs and laboratory tests of blood and urine

Exclusion Criteria

Clinically relevant abnormal findings at the screening assessment; acute or chronic illness; clinically relevant abnormal medical history or concurrent medical condition; positive tests for hepatitis B, hepatitis C, Human Immunodeficiency Virus (HIV)
Drug or alcohol abuse
Use of over-the-counter medication (with the exception of paracetamol [acetaminophen]) during the 7 days before the first dose of trial medication, or prescribed medication during the 28 days before first dose of trial medication
Participation in other clinical trials of unlicensed medicines within the 3 months or 5 half-lives, whichever is longer, before admission to this study
Loss of more than 400 mL blood, within the previous 3 months
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How to participate?

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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