Asthma Clinical Trial
Official title:
Phase I, Randomised, Blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8630 in Healthy Adult Subjects (Part A) and Adults With Asthma on Medium to High Dose Inhaled Corticosteroids and Long-acting Beta-agonists (Part B)
This is a first in human (FIH) clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8630 in healthy adults (Part A) and adult asthma patients on medium to high dose inhaled corticosteroids / Long-acting beta-agonists (Part B)
The study is divided in 2 parts, A and B. Part A will be conducted in healthy adults, whereas Part B will be conducted in adult asthma patients on medium/high dose inhaled corticosteroids (ICS)/long-acting beta-agonists (LABA) to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of AZD8630 by dry powder inhaler (DPI) administration. Part A includes the assessment of the PK and safety of intravenous (IV) AZD8630. Part A consists of single ascending dose (SAD) and multiple ascending dose (MAD) cohorts in sequential order and Part B will be evaluating multiple dose levels. Part A: This part will consist 4 sub-parts and will include healthy participants and healthy participants of Chinese and Japanese ethnicity. These participants will randomized to receive AZD8630 and to receive placebo. - Sub-Part A1, SAD in healthy participants (one cohort in Sub-Part A1 will receive IV AZD8630 [IV formulation]) - Sub-Part A2, SAD in healthy participants of Chinese and Japanese ethnicity - Sub-Part A3, MAD in healthy participants - Sub-Part A4, MAD in healthy participants of Chinese and Japanese ethnicity Part B: Adult asthma patients will be randomized to one of 3 inhaled dose levels of AZD8630 or placebo. The expected duration of study participation for each participants in the part A is up to 87 days, and each patients in the Part B is up to 70 days. ;
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