Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT05275660
Brief Summary:
The purpose of this study is to examine the safety and tolerability of HFB30132A when it is given by single intravenous infusion in Chinese healthy participants.
Detailed Description:
This is a Phase I, randomized, double-blind, placebo-controlled, dose escalation study in Chinese healthy volunteers.
The study will comprise of:
1. A Screening Period of up to 30 days (Day -30 through Day -1);
2. A Treatment Period during which participants will be resident at the Observation Unit from Day -1, 1 day before Investigational Medicinal Product (IMP) administration (on Day 1) until at least 48 hours (Day 3) after IMP administration. Participants will be discharged on Day 3 after all safety and/or pharmacokinetic (PK) evaluations have been completed, and
3. A Follow up Period lasting 270 days after the IMP dose.
Study:
NCT05275660
Study Brief:
Protocol Section:
NCT05275660