A Phase 1 interventional study of AL-794 and Placebo in Healthy, sponsored by Alios Biopharma Inc.. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Alios Biopharma Inc. · Phase 1, Interventional, and Other
The purpose of this study is to evaluate the safety and tolerability (including incidence of central nervous system [CNS] related events such as lightheadedness and dizziness), of multiple oral doses of AL-794 in healthy volunteers (HV). Also, to evaluate the pharmacokinetics of ALS-033719 and ALS-033927 in plasma after multiple oral doses of AL-794 in HV.
Exclusion Criteria:
Participants will receive AL-794 or placebo in 2:1 ratio in Cohorts 1 to 3. AL-794 will be administered at a 100 milligram (mg) loading dose (LD) on the morning of Day 1, followed by a 50 mg maintenance dose (MD) on the evening of Day 1 and twice-daily (BID) on Day 2 through Day 5. The duration of dosing may be extended (maximum duration 10 days), at the discretion of the Sponsor and Principal Investigator (PI).
Drug: AL-794 · Drug: Placebo
Participants will receive AL-794 or placebo in 2:1 ratio. AL-794 will be administered as 100 mg LD on the morning of Day 1, followed by a 50 mg MD on the evening of Day 1 and BID on Day 2 through Day 5. The duration of dosing may be extended (maximum duration 10 days). Based on the results of Part 1, the duration of dosing may be modified.
Drug: AL-794 · Drug: Placebo
AL-794 will be administered as tablets orally on Day 1 to Day 5.
Matching placebo tablets will be administered.
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a participant who received study drug or placebo without regard to possibility of causal relationship.
Time frame: Up to 40 days
Part 1: ALS-033719 Plasma Concentrations
Plasma concentration assessment will be done for ALS-033719 following multiple doses of AL-794.
Time frame: Predose up to Day 12
Part 2: ALS-033719 Plasma Concentrations
Plasma concentration assessment will be done for ALS-033719 following multiple doses of AL-794.
Time frame: Predose up to Day 5
Part 1: ALS-033927 Plasma Concentrations
Plasma concentration assessment will be done for ALS-033927 following multiple doses of AL-794.
Time frame: Predose up to Day 12
Part 2: ALS-033927 Plasma Concentrations
Plasma concentration assessment will be done for ALS-033927 following multiple doses of AL-794.
Time frame: Predose up to Day 5
Part 1: ALS-033719 Plasma Concentrations in Healthy Women in Fasted and Fed Conditions
Plasma concentration assessment will be done for ALS-033719, after repeated oral doses of AL-794, in healthy women under fasted and fed conditions.
Time frame: Predose up to Day 12
Part 1: ALS-033927 Plasma Concentrations in Healthy Women in Fasted and Fed Conditions
Plasma concentration assessment will be done for ALS-033927, after repeated oral doses of AL-794, in healthy women under fasted and fed conditions.
Time frame: Predose up to Day 12
Part 1 and Part 2: Time-Matched Q-T Interval Corrected for Heart Rate Using Fridericia Method (QTcF)
The QTcF will be measured by electrocardiogram (ECG).
Time frame: Up to 40 days
This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Alios Biopharma Inc.