None listed
Conditions
Brief summary
This is a Phase 1 Single and Multiple Ascending Dose Study of PBT434 in Healthy Volunteers. The first in human study consists of two parts, both of which are randomised, double-blind, and placebo-controlled: The single ascending dose (SAD) and the multiple ascending dose (MAD) parts of the study will be conducted in sequential stages. Key safety and PK data from the SAD portion will be reviewed before progressing to the MAD part of the study.
Interventions
PBT434 is supplied as 50mg and 200 mg immediate release oral capsules. The doses in the SAD phase are: 50 mg, 100 mg, 300 mg, and 600 mg, given as a single dose. Up to two additional dose levels may be evaluated if supported by available toxicology data and approved by the SRT.
Up to four dosage regimens of PBT434 will be evaluated in the MAD portion of the study; 100 mg twice a day (200 mg Total Daily Dose (TDD), 300 mg twice a day (600 mg TDD). Up to two additional dose regimens may be eval
PBT434 is supplied as 50mg and 200 mg immediate release oral capsules. The doses in the SAD phase are: 50 mg, 100 mg, 300 mg, and 600 mg, given as a single dose. Up to two additional dose levels may be evaluated if supported by available toxicology data and approved by the SRT. Up to four dosage regimens of PBT434 will be evaluated in the MAD portion of the study; 100 mg twice a day (200 mg Total Daily Dose (TDD), 300 mg twice a day (600 mg TDD). Up to two additional dose regimens may be evaluated based on available PK, safety, and toxicological data. The dose in the multiple ascending dose (MAD) phase is given twice daily for Days 1-7, and once daily on Day 8. Participants do not take part in both the SAD and MAD phases. The phases are independently randomised. In both the SAD and MAD phases, hand and mouth checks will be performed after each dose to assure that IP has been swallowed by the subject.
Sponsors
Alterity Therapeutics
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
SAD and MAD phases require healthy male and female adult volunteers aged between 18 and 55 (n=106 total in this age group). One cohort of the MAD phase will be conducted in healthy elderly participants. The elderly cohort in MAD will be comprised of healthy male and female (not of childbearing potential) volunteers aged greater than or equal to 65 years (n=10 participants in this age group).
Exclusion criteria
History or presence of malignancy, clinically relevent medical illness, including cardiovascular, GI, hepatic, renal endocrine, neurologic and psychiatric, systemic allergic disease.
Outcome results
None listed