NCT05275660

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of HFB30132A Against COVID-19 in Chinese Healthy Adults

A Phase I Randomized, Double-Blind, Placebo-Controlled Study Investigating the Safety, Tolerability, and Pharmacokinetics of Single Dose Intravenously Administered HFB30132A, a Monoclonal Antibody Against SARS-CoV-2, in Chinese Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: HiFiBiO Therapeutics · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HFB30132A	Participants randomized to HFB30132A will be administered dose 1 in cohort 1. Participants in Cohort 2 will receive HFB30132A dose 2.
OTHER	Placebo	Participants randomized to placebo will receive the same volume of solution as participants on active treatment.

Timeline

• Start date: 2021-05-09
• Primary completion: 2022-02-22
• Completion: 2022-02-22
• First posted: 2022-03-11
• Last updated: 2022-03-11

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study