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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of AZD8848 in healthy subjects.

AZD8848 single ascending dose study

A Double-blind, Placebo-controlled, Randomised Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD8848 in Healthy Subjects

NCT ID

Therapeutic Area

Single dose, oral inhalation (nebuliser solution)

Research Site

Age Continuous

Gender, Male/Female

Subject characteristics (Height)

Study Specific Characteristic

Subject characteristics (Weight)

Subject characteristics (BMI)

All available data were used for the  baseline analysis

Summary of number of subjects who had at least one adverse event

Adverse Events

Summary (geometric mean and GCV%) of pharmacokinetic
parameters of total AZ12432045 - AUC (nmol*h/L)

Summary (geometric mean and GCV%) of pharmacokinetic
parameters of total AZ12432045 - AUC(0-t) (nmol*h/L)

Summary (geometric mean and GCV%) of pharmacokinetic
parameters of total AZ12432045 - Cmax (nmol/L)

Smmarizes the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix

Statistical assessment of CXCL10 ratio-to-baseline - Plasma

Smmarize the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix

Baseline

Day 1

Day 2

Day 3

Follow up (up to Day 13)

Summary for Lymphocytes laboratory results

Summarize the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix

Arms	Assigned Interventions
Experimental: AZD8848	Drug: AZD8848 Single dose, oral inhalation (nebuliser solution)
Placebo Comparator: Placebo	Drug: Placebo Single dose, oral inhalation (nebuliser solution)

AZD8848 single ascending dose study

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

CSR Synopsis

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator