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Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GB-0669 in Healthy Adult Participants
NCT07050511 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Placebo
- DRUG GB-0669
Study Locations (1)
Massachusetts
- Generate Biomedicines — Somerville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2023-07-18 |
| Est. Completion | 2024-11-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07050511
The ClinicalTrials.gov registry entry for NCT07050511 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Generate Biomedicines, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with SARS CoV-2 appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07050511 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07050511 about?
NCT07050511 is a clinical study titled "Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GB-0669 in Healthy Adult Participants". 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 o...
What is the current status of trial NCT07050511?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2023-07-18. Estimated completion is 2024-11-22.
What conditions does trial NCT07050511 study?
This clinical trial studies the following conditions: SARS CoV-2. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07050511?
The interventions under investigation include: Placebo (DRUG), GB-0669 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07050511?
This trial is sponsored by Generate Biomedicines, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07050511 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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