ACTRN12622001534774
Completed
Phase 1
Phase 1 dose-escalation study assessing the safety and pharmacokinetics of PTC607 in healthy volunteers
CTI Clinical Trial and Consulting Services Australia Pty Ltd.0 sites40 target enrollmentDecember 12, 2022
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Huntington's Disease
- Sponsor
- CTI Clinical Trial and Consulting Services Australia Pty Ltd.
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Males and females aged 18 to 65 years inclusive at Screening
- •2\. Participants able to provide informed consent
- •3\. Body mass index of greater than or equal to 18\.5 and less than or equal to 30\.0 kg/m2 with a body weight of greater than or equal to 50\.0 kg for male
- •participants and a body weight of greater than or equal to 45\.0 kg for female participants at Screening
- •4\. Generally healthy as determined by the investigator based on medical evaluation, including medical history, physical examination, laboratory test results, ECG, and vital signs.
- •5\. Male participants must be willing to use 2 acceptable contraceptive methods for the duration of the study and for a minimum of 6 months after the last dose, and female participants of childbearing potential must be willing to use 2 acceptable contraceptive methods for the duration of the study and for a minimum of 30 days after the last dose.
- •6\. All female participants of childbearing potential must have a negative serum pregnancy
- •test result at Screening and a negative urine pregnancy test on Day \-1\.
- •7\. Male participants must agree to not donate sperm for the duration of the study and for at
- •least 6 months after the last dose.
Exclusion Criteria
- •1\. Participants that participated in any drug or device clinical investigation within 60 days
- •prior to Screening or who anticipate participating in any drug or device clinical
- •investigation within the duration of this study.
- •2\. Prior or ongoing medical condition (eg, concomitant illness, psychiatric condition),
- •medical history, and/or physical findings that, in the investigator’s opinion, could
- •adversely affect the safety of the participant or could impair the assessment of study
- •3\. An abnormal general neurological examination.
- •4\. Presence of any clinically significant abnormality during Screening.
- •5\. Any psychological or emotional problems, any disorders, or resultant therapy that is
- •likely to invalidate informed consent or limit the ability of the participant to comply with
Outcomes
Primary Outcomes
Not specified
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