Safety, Tolerability, and Pharmacokinetic Evaluation of ADB116 for Injection

Condition(s) studied

Investigational drug(s) / intervention(s)

ADB116 for Injection: ADB116 for Injection, single intravenous bolus injection

Placebo for ADB116 for Injection: Matching placebo, single intravenous bolus injection

Study summary

A Phase I Study of ADB116 for Injection in Healthy Chinese Adults. This study aims as follows:

Primary Objective:

• To evaluate the safety and tolerability of a single intravenous bolus dose of ADB116 for injection in healthy Chinese adults.

Secondary Objective:

• To evaluate the pharmacokinetic (PK) profile of a single intravenous bolus dose of ADB116 for injection.

Eligibility

Primary outcome measure(s)

• Frequency of Treatment-emergent Adverse Events (TEAEs) following a single dose of ADB116 for injection — From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
  Safety and tolerability assessed by the frequency, relationship to treatment, severity (using CTCAE criteria, if applicable), seriousness, and expectedness of TEAEs, including adverse drug reactions (ADRs), Grade ≥3 AEs, serious adverse events (SAEs), serious adverse drug reactions (SADRs), AEs leading to treatment interruption, and AEs leading to premature study withdrawal.
• Pharmacokinetic (PK) parameters：Cmax — From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
  Cmax is defined as the highest concentration of the drug reached in the body (usually in plasma, whole blood, or serum) after administration.
• Pharmacokinetic (PK) parameters： AUC0-t — From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
  Area under the plasma concentration-time curve from time zero to the last measurable concentration
• Pharmacokinetic (PK) parameters： AUC0-∞ — From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
  Area under the plasma concentration-time curve from time zero extrapolated to infinity
• Pharmacokinetic (PK) parameters：t1/2 — From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
  The time required for the concentration of a drug in the body (typically in plasma) to decrease by one-half.
• Pharmacokinetic (PK) parameters：Vz/F — From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
  The theoretical volume in which the total amount would need to be uniformly distributed to produce the observed plasma concentration
• Pharmacokinetic (PK) parameters：CL/F — From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
  The apparent volume of plasma from which the drug is completely removed per unit time, adjusted for bioavailability (F). It reflects the efficiency of drug elimination following extravascular administration.
• Pharmacokinetic (PK) parameters：λz — From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
  Terminal elimination rate constant
• Pharmacokinetic (PK) parameters：percentage of AUC extrapolated (AUC_%Extrap) — From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
  Percentage of AUCinf due to extrapolation from Tlast to infinity
• Pharmacokinetic (PK) parameters： MRT0-t — From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
  Mean residence time from time zero to the last measurable concentration
• Pharmacokinetic (PK) parameters： MRT0-∞ — From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
  Mean residence time from time zero extrapolated to infinity

Trial sites (1)

More Jiangsu Aidea Pharmaceutical Group Co., Ltd. trials in China

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