A Phase I Study to Evaluate the Pharmacokinetics and Safety of a Single Dose of Duvakitug in Healthy Adult Participants

The primary objective is to evaluate the pharmacokinetics and safety of a single dose of duvakitug in healthy adult participants. Assessing these parameters is essential for determining the drug's absorption, distribution, metabolism, and excretion profiles, as well as identifying potential adverse effects following administration. 6, 4

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both male and female subjects. The participants belong to vulnerable populations and fall within the age range of 3 to 12 years.

This Phase 1 clinical trial is designed as a study to investigate the pharmacokinetics and safety of a single dose of duvakitug in healthy volunteers. The research methodology involves a sequence of study visits beginning with a screening visit to assess eligibility. Following the administration of the study drug, participants will undergo scheduled follow-up visits to monitor physiological responses and drug concentration levels. The process concludes with an end-of-study visit. The total duration of participation is determined by the protocol, and study termination may occur if specific predefined clinical conditions are met.

The efficacy assessment for this study involving healthy volunteers is not specified.