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

NCT07050511 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-07-03

No results posted yet for this study

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.

Conditions

  • SARS CoV-2

Interventions

DRUG

GB-0669

Single IV infusion of GB-0669.

DRUG

Placebo

Single IV infusion of placebo. Sterile 0.9% (w/v) sodium chloride solution.

Sponsors & Collaborators

  • Generate Biomedicines

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-18
Primary Completion
2024-11-22
Completion
2024-11-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07050511 on ClinicalTrials.gov