Health TrialsbyHealthPanel

A Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adults

ConditionStaphylococcus Aureus Bloodstream Infection
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAstraZeneca

About this trial

The purpose of this study is to evaluate the safety and PK of AZD7760 when given as an intravenous (IV) infusion to healthy Japanese adult participants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Body weight ≥ 45 kg and ≤ 110 kg and BMI within the range of ≥ 18.0 to ≤ 30.0 kg/m2 (inclusive) at screening.

Healthy Japanese participants with no clinically significant concomitant diseases or medications.

Disqualifiers

Known hypersensitivity to any component of the study intervention.

Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of mAbs.

Clinically significant bleeding disorder or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.

AST or ALT above 1.5 × ULN at screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AZD7760

    Drug

    Participants will receive AZD7760 via IV infusion.

  • Placebo

    Other intervention

    Participants will receive matching placebo via IV infusion.

Treatment groups

18 Participants
are divided into 3 treatment groups
Group A: Cohort 1 (AZD7760 Dose A)Experimental treatment 1 intervention
Group B: Cohort 2 (AZD7760 Dose B)Experimental treatment 1 intervention
Group C: Pooled PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Occurrence of Adverse Events (AEs)

To evaluate the safety of AZD7760 administered as a single IV Dose A or Dose B in healthy Japanese adult participants.

Time frame
Day 1 to Day 181
2

Occurrence of Medically-attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)

To evaluate the safety of AZD7760 administered as a single IV Dose A or Dose B in healthy Japanese adult participants.

Time frame
Day 1 to Day 361

Secondary outcomes

1

Maximum observed serum (peak) drug concentration (Cmax)

To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.

Time frame
Day 1 to Day 361
2

Time to reach peak or maximum observed concentration following drug administration (tmax)

To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.

Time frame
Day 1 to Day 361
3

Terminal elimination half-life (t½λz)

To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.

Time frame
Day 1 to Day 361
4

Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast)

To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.

Time frame
Day 1 to Day 361

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Research Site Status unavailable 130-0004, Sumida-kuJapanJapan

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Parexel

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: