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Clinical Trials/NL-OMON54871
NL-OMON54871
Completed
Not Applicable

A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of UBITh® PD Immunotherapeutic Vaccine (UB-312) in Healthy Participants and Participants with Parkinson*s Disease - Safety, Tolerability, and Immunogenicity of UB-312 in HV and PD patients

nited Neuroscience (Subsidiary of Vaxxinity)0 sites70 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
nited Neuroscience (Subsidiary of Vaxxinity)
Enrollment
70
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
nited Neuroscience (Subsidiary of Vaxxinity)

Eligibility Criteria

Inclusion Criteria

  • •Participants may be included in the clinical trial only if they meet all of the
  • •following criteria:
  • •1\. Written informed consent is signed and dated by the participant
  • •2\. Male or female aged 40 to 85 years old, inclusive at screening
  • •3\. Participants must have a body mass index (BMI) between 18 and 32 kg/m2,
  • •inclusive at screening, and with a minimum weight of 50 kg
  • •4\. Expected to be able to undergo all study procedures
  • •5\. Women must be of non\-childbearing potential (postmenopausal for at least 12
  • •months prior to screening or surgically sterile documented) or if of
  • •child\-bearing potential, must be using medically acceptable contraceptive

Exclusion Criteria

  • •Participants will be excluded from the clinical trial for any of the following
  • •1\. Clinically significant abnormalities, as judged by the investigator, in test
  • •results (including hepatic and renal panels, complete blood count, chemistry
  • •panel, urinalysis and imaging). In the case of uncertain or questionable
  • •results, tests performed during screening may be repeated before randomization
  • •to confirm eligibility or judged to be clinically irrelevant.
  • •2\. History of medical, neurological or psychiatric conditions, which in the
  • •opinion of the investigator may compromise participant\*s safety or scientific
  • •value of the study, posing an unacceptable risk to the participant or interfere
  • •with the participant's ability to comply with study procedures or abide by

Outcomes

Primary Outcomes

Not specified

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