NCT07050511

Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GB-0669 in Healthy Adult Participants

A Phase 1, Randomized, Double-blind, Placebo-controlled, Sequential Group, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GB-0669 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Generate Biomedicines · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to test the safety and tolerability of a single ascending dose (SAD) of GB-0669 administered intravenously in adults. The goal of this study is also to measure the blood levels of GB-0669 in the body. Study participants will be assigned to receive the study drug or placebo (the placebo is called saline; it is a liquid like salt water and made to look like the study drug but contains no active ingredient). The study is blinded, which means you and the study doctor will not know whether you are getting the study drug or placebo. Study participants will be assigned to one of 5 cohorts (study groups). Each cohort will have a single ascending dose (SAD). The first two SAD cohorts will have 3 study participants receiving GB-0669 and 3 study participants receiving placebo. The last three SAD cohorts will have 10 study participants receiving GB-0669 and 3 study participants receiving placebo. The SAD cohort dose levels will be as follows: 100 mg, 300 mg, 600 mg, 1200 mg, 2400 mg.

Detailed description

This is a randomized, double-blinded, placebo-controlled first in human (FIH) trial to evaluate the safety, tolerability, and pharmacokinetics of GB-0669 in healthy study participants. The trial is designed to administer the GB-0669 drug product intravenously at 5 single ascending dose (SAD) cohort dose levels. Eligible study participants will be screened and randomized to receive either GB-0669 or placebo in each cohort. The safety of the participants enrolled in this trial will be carefully monitored. There will be an independent safety review committee (iSRC) that will review ongoing safety for this trial and provide recommendations to proceed with the cohorts.

Conditions

• SARS CoV-2

Interventions

Type	Name	Description
DRUG	GB-0669	Single IV infusion of GB-0669.
DRUG	Placebo	Single IV infusion of placebo. Sterile 0.9% (w/v) sodium chloride solution.

Timeline

• Start date: 2023-07-18
• Primary completion: 2024-11-22
• Completion: 2024-11-22
• First posted: 2025-07-03
• Last updated: 2025-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study