LIBELULADebio 4326 para la supresión de LH en la pubertad precoz central pediátrica

Debio 4326

Part A: Percentage of Participants With Suppression of Gonadotropin-Releasing Hormone Agonist Stimulated Serum Luteinizing Hormone (LH) to Less Than or Equal to (≤)5 International Units per Liter (IU/L)

Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs) and Serious TEAEs

Parts A and B: Number of Participants with Clinically Significant Abnormalities in Vital Signs

Parts A and B: Change From Baseline in Body Weight

Parts A and B: Change From Baseline in Body Mass Index

Parts A and B: Number of Participants With Erythema, Swelling, and Induration at the Injection Site Immediately and 2 Hours After Each Debio 4326 Injection as per Investigator's Assessment

Parts A and B: Number of Participants With Pain at the Injection Site Immediately and 2 Hours After Each Debio 4326 Injection as per Participant's Assessment Using the Wong-Baker FACES® Pain Rating Scale

Parts A and B: Percentage of Participants Who do not Exhibit the Acute-on-Chronic (AOC) Phenomenon

Parts A and B: Percentage of Participants With Stimulated Serum LH ≤5 IU/L

Parts A and B: Percentage of Participants With Stimulated Serum LH ≤4 IU/L

Parts A and B: Number of Participants With Change in Hormone Levels

Parts A and B: Percentage of Girls With Prepubertal Serum Estradiol <20 pg/mL (<73 pmol/L)

Parts A and B: Percentage of Boys With Testosterone <30 ng/dL (<1.0 nmol/L)

Parts A and B: Change From Baseline in Height-for-Age Z Score

Parts A and B: Number of Participants With Change From Baseline in Growth Velocity

Percentage of Participants in Whom the Bone Age/Chronological Age Did Not Rise Relative to Baseline

Parts A and B: Percentage of Participants Who Achieve Stabilization of Sexual Maturation (Regression or Stabilization Compared to Baseline by Tanner Staging)

Parts A and B: Percentage of Girls With Regression of Uterine Length (Using Transabdominal Ultrasound)

Parts A and B: Percentage of Boys With Absence of Progression of Testis Volumes (Clinical Assessment With Orchidometer)

Parts A and B: Plasma Concentration of Triptorelin

Percentage of Participants With Stimulated Serum LH Levels Greater Than (>)5 IU/L at Post Treatment Visit (PTV)

Part B: Accumulation Ratio on Maximum Serum Concentration (RacCmax)

Part B: Accumulation Ratio on Serum Concentration at the End of the Dosing Interval (RacCtrough)