Phase 1, randomised, double-blind, first in human, two part, single centre, placebo controlled, single and multiple ascending dose trial in healthy adult subjects to evaluate the safety, tolerability and pharmacokinetics of HTL0022562.
This is a first in human, two part, double blind, placebo controlled, randomised single and multiple ascending subcutaneous dose study to evaluate the safety, tolerability and pharmacokinetics of HTL0022562. Part 1 comprises of 7 sequential ascending dosing cohorts and Part 2 comprises of 4 multiple ascending dosing cohorts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
33
HTL0022562
Placebo
Parexel Early Phase Clinical Unit
Harrow, Middlesex, United Kingdom
Number of Treatment Emergent Adverse Events (TEAEs)
All Adverse Events (AEs), including clinical laboratory, vitals signs, body temperature, respiratory rate, physical examinations, local tolerability and site injection reactions, and ECGs will be analyzed in all subjects.
Time frame: Screening up to post last dose: Day 8 (Part 1) / Day 15 (Part 2)
Part 1 and Part 2: Cmax
Plasma pharmacokinetic parameter: maximum systemic concentration of HTL0022562
Time frame: Part 1 up to Day 8, Part 2 up to Day 15
Part 1 and Part 2: Tmax
Plasma pharmacokinetic parameter: time to Cmax of HTL0022562 Plasma pharmacokinetic parameter: time to Cmax of HTL0022562
Time frame: Part 1 up to Day 8, Part 2 up to Day 15
Part 1 and Part 2: Area Under Curve (AUC)
Plasma pharmacokinetic parameter: Area under the plasma concentration versus time curve derived from systemic concentrations of HTL0022562
Time frame: Part 1 up to Day 8, Part 2 up to Day 15
Part 1 and Part 2: Ae
Urine pharmacokinetic parameter: Amount of HTL0022562 recovered in urine for each urine collection interval
Time frame: Part 1 up to Day 8, Part 2 up to Day 15
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