A Study of the Safety of REN001 in Patients With McArdle Disease

  • STATUS
    Recruiting
  • participants needed
    16
  • sponsor
    Reneo Pharma Ltd
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Updated on 19 February 2024
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Summary

The purpose of this study is to assess REN001 safety in subjects with McArdle Disease

Details
Condition Glycogen Storage Disease Type V
Age 18years - 100years
Treatment REN001
Clinical Study IdentifierNCT04226274
SponsorReneo Pharma Ltd
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Subjects must give written, signed and dated informed consent
Confirmed diagnosis of McArdle Disease
Subjects must be able to remain on stable medication through the study and specifically must not commence or have changes to agents that affect metabolism such as medication for diabetes
Follow a stable dietary regimen as documented by a 3-day dietary record obtained during the screening period

Exclusion Criteria

Documented history of ongoing rhabdomyolysis
Evidence of acute crisis from their underlying disease
Currently following or planning to start a ketogenic diet
Treatment with an investigational drug within 1 month or within 5 half-lives, whichever is longer
Have been hospitalized within the 3 months prior to screening for any major medical condition
Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator in discussion with the Medical Monitor, would make the subject inappropriate for entry into this study
Pregnant or nursing females
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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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