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NCT07050511 · ClinicalTrials.gov registry record · Phase 1
Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GB-0669 in Healthy Adult Participants
A Phase 1 study of SARS-CoV-2, sponsored by Generate Biomedicines.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
- 1
- Study location
NCT07050511: Completed Phase 1 study of SARS-CoV-2, sponsored by Generate Biomedicines.
NCT07050511 is a Phase 1 study of SARS-CoV-2 that has completed, run by Generate Biomedicines. The registered enrollment target is 51 participants, below the 3,453-participant average among 34 other SARS-CoV-2 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07050511, a Phase 1 study of SARS-CoV-2, has completed, sponsored by Generate Biomedicines.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Participant incidence and severity of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to discontinuation of study treatment. Clinically significant (CS) changes from baseline in: Clinical laboratory results (hematology, clinical chemistry, coagulation and urinalysis, vital signs, twelve-lead electrocardiograms (ECGs).
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 |
What the finished NCT07050511 record still lists
NCT07050511 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 3,453-participant average among 34 other SARS-CoV-2 trials with a reported enrollment target (99% lower).
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.
NCT07050511 reports a single indexed study location in Massachusetts.
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.
What interventions are being tested in trial NCT07050511?
The interventions under investigation include: Placebo (DRUG), GB-0669 (DRUG).
Who is sponsoring clinical trial NCT07050511?
This trial is sponsored by Generate Biomedicines, which has 5 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT07050511's enrollment target sits among peer trials
51 30th of 34 higher than 5 of 34 other SARS-CoV-2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other SARS-CoV-2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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