Retosiban in Preterm Labor

• Retosiban (Part A/B)

  IV Retosiban (12h) followed by Oral Retosiban

• Placebo (Part A/B)

  IV Placebo (12h) followed by Oral Placebo

• Retosiban (Part C)

  IV Retosiban (48h)

• Placebo (Part C)

  IV Placebo (48h)

Primary

• Number of Participants With Vital Sign Values of Potential Clinical ConcernUp to Week 12

• Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical ConcernUp to Week 12

• Number of Participants With Clinical Chemistry and Hematology Parameter Values of Potential Clinical ConcernUp to 24 hours post-treatment

• Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)Up to Week 12

• Assessment of Amniotic Fluid Index (AFI)Up to 48 hours post-dose

Secondary

• Number of Participants With Preterm Births in Part CUp to 48 hours post-dose

• Neonatal Apgar Scores4-12 weeks post adjusted gestational age

• Neonatal Weight Gain4-12 weeks post adjusted gestational age

• Neonatal Head Circumference4-12 weeks post adjusted gestational age

• Neonatal Length4-12 weeks post adjusted gestational age

• Area Under Concentration-time Curve (AUC)Up to 48 hours

• Maximum Plasma Concentration (Cmax)Up to 48 hours

• Number of Participants Who Remained Undelivered Without Rescue Tocolytic Therapy After 48 Hours in Part C48 hours post-dose