This is a First in Human study to assess the safety and tolerability of AZD7624, following inhaled administration of single ascending doses in healthy male volunteers and female volunteers of non-child bearing potential. Pharmacokinetics (what the body does to the drug) and pharmacodynamic (what the drug does to the body) parameters will be also assessed as secondary objectives.
A Double-blind Placebo-controlled, Randomised, Single centre, First Time in Man Study to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD7624 in Healthy Subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
57
Single dose inhaled IMP via a nebulizer
Single dose inhaled Placebo via a nebulizer
Research Site
London, United Kingdom
Safety variables (adverse events, vital signs, body temperature, ECGs, clinical laboratory safety tests and spirometry)
Time frame: up to 55 days.
Pharmacokinetics of AZD7624 and assess dose proportionality of the pharmacokinetics following single ascending doses of AZD7624 by assessment of Cmax, t1/2, AUC and CL/F.
Time frame: Day 1 pre-dose, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 9h,12h, 18h, 24h, 36h, 48h, 56h post dose
Pharmacokinetics of single doses of AZD7624 using the following urine PK parameters: Ae and CLR
Time frame: Day 1: during 0-6, 6-12, 12-24 and 24-48 hours post dose.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.