A Phase I Randomized, Double-blind Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD4041 Following Single Ascending Dose Administration to Healthy Volunteers

Number of Adverse Events

时间窗: 6 weeks

Number of participants experiencing any adverse event

Number of Participants With Treatment-Related Moderate TEAEs

时间窗: 6 weeks

Number of participants experiencing any treatment-related moderate TEAEs

Number of Participants With Moderate TEAEs

时间窗: 6 weeks

Number of participants experiencing any moderate TEAEs

Number of Participants With Treatment-Related SAEs

时间窗: 6 weeks

Number of participants experiencing any treatment-related serious adverse events (SAEs)

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

时间窗: 6 weeks

Number of participants experiencing any treatment emergent adverse events

Number of Participants With Treatment-Related TEAEs

时间窗: 6 weeks

Number of participants experiencing any treatment-related TEAEs

Number of Participants With Abnormal Vital Signs (Blood Pressure)

时间窗: 6 weeks

Number of participants with treatment-related abnormal blood pressure considered clinically significant or reported as a treatment-emergent adverse event by the investigator

Number of Participants With Abnormal Vital Signs (Heart Rate)

时间窗: 6 weeks

Number of participants with treatment-related abnormal heart rate considered clinically significant or reported as a treatment-emergent adverse event by the investigator

Pulse Rate at Baseline and Day 1 2 Hours Post.

时间窗: Baseline and Day 1

Measured by standing pulse rate at baseline and 2 hours post

Number of Participants With Abnormal Safety Laboratory Tests (Hematology)

时间窗: 6 weeks

Number of participants with treatment-related abnormal hematology values considered clinically significant or reported as a treatment-emergent adverse event by the investigator

Number of Participants With Abnormal Safety Laboratory Tests (Serum Chemistry)

时间窗: 6 weeks

Number of participants with treatment-related abnormal serum chemistry values considered clinically significant or reported as a treatment-emergent adverse event by the investigator

Number of Participants With Abnormal Safety Laboratory Tests (Urinalysis)

时间窗: 6 weeks

Number of participants with treatment-related abnormal urinalysis values considered clinically significant or reported as a treatment-emergent adverse event by the investigator

Number of Participants With Abnormal 12-lead ECGs

时间窗: 4 days

Number of participants with abnormal 12-lead electrocardiograms (ECGs), considered clinically significant or reported as a treatment-emergent adverse event by the investigator

Heart Rate at Baseline and Times Post Dose

时间窗: Thru Day 4

Measured by digital electrocardiograms (ECGs)

Aggregate P-R Interval at Baseline and Time Post Dose

时间窗: Thru Day 4

PR interval is the time from the beginning of atrial depolarization to the onset of ventricular depolarization. Measured by digital electrocardiograms (ECGs)

Aggregate QRS Complex at Baseline and Times Post Dose

时间窗: Thru Day 4

QRS complex represents the electrical impulse as it spreads through the ventricles and indicates ventricular depolarization. Measured by digital electrocardiograms (ECGs)

Aggregate QT Interval at Baseline and Times Post Dose

时间窗: Thru Day 4

The QT interval is measured from the beginning of the QRS complex to the end of the T wave and primarily represents the return of stimulated ventricles to their resting state (ventricular repolarization). Measured by digital electrocardiograms (ECGs)

Aggregate QTcF Interval and Times Post Dose

时间窗: Thru Day 4

The QTcF if the QT interval corrected for heart rate using Fridercia's formula. Measured by digital electrocardiograms (ECGs)

Number of Participants With Abnormal Luteinizing Hormone Test Results

时间窗: Thru Day 4

Number of participants with abnormal luteinizing hormone (LH) levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator

Number of Participants With Abnormal Follicle Stimulating Hormone Test Results

时间窗: Thru Day 4

Number of participants with abnormal follicle stimulating hormone (FSH) levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator

Number of Participants With Abnormal Inhibin B Test Results

时间窗: Thru Day 4

Number of participants with abnormal Inhibin B levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator

Number of Participants With Severe TEAEs

时间窗: 6 weeks

Number of participants experiencing any severe TEAEs

Number of Participants With Treatment-Related Severe TEAEs

时间窗: 6 weeks

Number of participants experiencing any treatment-related severe TEAEs

Number of Participants With Serious Adverse Events (SAEs)

时间窗: 6 weeks

Number of participants experiencing any serious adverse events (SAEs)

Number of Participants With TEAEs Leading to Early Discontinuation

时间窗: 6 weeks

Number of participants with treatment-emergent adverse events leading to early discontinuation

Number of Participant Deaths

时间窗: 6 weeks

Number of participants who died

Number of Participants With Abnormal Vital Signs

时间窗: 6 weeks

Number of participants with treatment-related abnormal vital signs considered clinically significant or reported as a treatment-emergent adverse event by the investigator.

Aggregate RR Interval at Baseline and Times Post Dose

时间窗: Thru Day 4

The RR interval the time elapsed between two successive R waves of the QRS signal on the electrocardiogram. Measured by digital electrocardiograms (ECGs)

Number of Participants With Abnormal Testosterone Test Results

时间窗: Thru Day 4

Number of participants with abnormal testosterone levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator