SARS CoV-2Phase 1NCT07050511
Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GB-0669 in Healthy Adult Participants
A Phase 1 study testing GB-0669 in people with SARS CoV-2, run by Generate Biomedicines at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS CoV-2
- What is being tested?
- GB-0669
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2023to 22 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects
- Adults, 18 to 55 years of age (inclusive) at screening
- Body mass index (BMI) ≥ 19.0 and ≤ 35.0 kg/m2
- Medically healthy without clinically significant abnormalities at screening and pre-dose on Day 1
- Negative SARS-CoV-2 rapid antigen or PCR tests prior to randomization
- Physical examination without any clinically relevant findings
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- Systolic blood pressure in the range of 90 to 140 mmHg and diastolic blood pressure in the range of 50 to 90 mmHg after 5 minutes in seated, semi-recumbent, or supine position
- Heart rate (HR) in the range of 50 to 100 bpm after 5 minutes rest in seated, semi-recumbent, or supine position
- Body temperature, between 35.0°C and 37.5°C
- In the opinion of the investigator, no significant findings in serum chemistry, hematology, coagulation, and urinalysis tests
- Female subjects of childbearing potential, defined as any woman who has experienced menarche and who is not permanently sterile or postmenopausal, must have negative blood pregnancy tests at screening (and negative urine pregnancy tests on Day 1) and must agree to use protocol-defined methods of contraception from screening through at least 90 days after study completion
- Male subjects must agree to use protocol-defined methods of contraception and agree to refrain from donating semen from screening through at least 90 days after study completion
- Have suitable venous access for intravenous infusion and blood sampling
- Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions including staying overnight in the CRU.
Who cannot join
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, oncological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease, including any acute illness or surgery within the past 3 months determined by the principal investigator (PI) to be clinically relevant. Subjects with localized cancers treated with curative intent and not on active therapy are allowed
- Current infection that requires antibiotic, antifungal, antiparasitic or antiviral medications
- Acute illness or fever within 3 days before study enrollment (enrollment may be delayed for full recovery if acceptable to the investigator)
- Abnormal EKG or any known cardiac condition determined by the PI to be clinically Current infection that requires antibiotic, antifungal, antiparasitic or antiviral medications
- Positive testing for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C antibodies (HCV)
- Women currently pregnant, lactating, or planning a pregnancy between enrollment and final study visit, or intends to donate ova during this time period
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- Male participants intend to donate sperm during this study or before the end of the study
- Any history of anaphylactic-type reaction to any substance or any history of infusion related reactions or any allergy to components of the study drug
- Blood donation or significant blood loss (i.e., > 500 mL) within 56 days prior to Day 1
- Plasma donation within 7 days prior to Day 1
- Use of more than an average of 5 packs/week of tobacco/nicotine-containing product within 6 months prior to Day 1. Subjects must agree to refrain from smoking for the duration of the study
- Excessive intake of alcohol, defined as an average daily intake of greater than 2 standard drinks for women and 4 standard drinks for men, (1 bottle of beer (375mL) is equivalent to approximately 1.4 standard drinks, 1 glass of spirits (30mL) is equivalent to approximately 1 standard drink and 1 glass (150mL) of wine is equivalent to approximately 1.5 standard drinks)
- History of alcohol abuse, illicit drug use, physical dependence to any opioid, or any history of drug abuse or addiction within 2 years prior screening
- Individuals currently participating or planning to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, or medication); or who have received an experimental agent within 1 month (or 3 half-lives) before enrollment of this study; or expect to receive another experimental agent during participation of this study
- Positive urine test for drugs of abuse or alcohol (legal amounts of tetrahydrocannabinol (THC) are allowed)
- Unwilling or unlikely to comply with the requirements of this study
- Any condition or disease that, in the opinion of the Investigator, would pose a risk to participant safety or interfere with study evaluation, procedures or completion
Trial locations and contacts
1 site in 1 country.
United States1 site
Generate Biomedicines
Somerville, Massachusetts, 02143
About this study
Official title: 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
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).
Read more
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.
Read the 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
- Being tested
- GB-0669, Placebo
- Keywords
- SARS CoV-2, GB-0669
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB-0669Drug
Single IV infusion of GB-0669.
PlaceboDrug
Single IV infusion of placebo. Sterile 0.9% (w/v) sodium chloride solution.
| Study group | Role | What they receive |
|---|---|---|
| Study Intervention GB-0669 | Experimental | Study intervention Receives: Drug: GB-0669 |
| Placebo | Placebo comparator | sterile 0.9% (w/v) sodium chloride solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of a single ascending dose of GB-0669 administered intravenously in healthy volunteers
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).
Measured: Day -1 to Day 302
Secondary outcomes (8)
To characterize the maximum concentration (Cmax) of GB-0669 following single doses of GB-0669 administered intravenously in healthy volunteers
The Cmax of GB-0669 following single doses in healthy volunteers will be analyzed
Measured: Day 1 to Day 302
To characterize the time to peak drug concentration (Tmax) of GB-0669 following single doses of GB-0669 administered intravenously in healthy volunteers
The Tmax of GB-0669 following single doses in healthy volunteers will be analyzed
Measured: Day 1 to Day 302
To characterize the half-life (t1/2) of GB-0669 following single doses of GB-0669 administered intravenously in healthy volunteers
The t1/2 of GB-0669 following single doses in healthy volunteers will be analyzed
Measured: Day 1 to Day 302
To characterize the area under the curve to last quantifiable timepoint (AUClast) of GB-0669 following single doses of GB-0669 administered intravenously in healthy volunteers
The AUClast of GB-0669 following single doses in healthy volunteers will be analyzed
Measured: Day 1 to Day 302
To characterize the volume of distribution (V/F) of GB-0669 following single doses of GB-0669 administered intravenously in healthy volunteers
The V/F of GB-0669 following single doses in healthy volunteers will be analyzed
Measured: Day 1 to Day 302
To characterize the area under the plasma concentration- time curve (AUC) of GB-0669 following single doses of GB-0669 administered intravenously in healthy volunteers
The AUC of GB-0669 following single doses in healthy volunteers will be analyzed
Measured: Day 1 to Day 302
To characterize the total body clearance from plasma (CL/F) of GB-0669 following single doses of GB-0669 administered intravenously in healthy volunteers
The CL/F of GB-0669 following single doses in healthy volunteers will be analyzed
Measured: Day 1 to Day 302
To characterize the area under the plasma concentration-time curve from time zero to infinity (AUCinf) of GB-0669 following single doses of GB-0669 administered intravenously in healthy volunteers
The AUCinf of GB-0669 following single doses in healthy volunteers will be analyzed
Measured: Day 1 to Day 302
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start18 Jul 2023
- Primary completion22 Nov 2024
- Study completion22 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Generate Biomedicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050511
- Sponsor's protocol ID
- GB-0669-101
- Status last verified
- Jun 2025
- First submitted
- 21 May 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This study was a Phase 1 trial conducted in healthy volunteers to assess safety and pharmacokinetics. Individual participant data will not be shared due to the limited clinical relevance of the data outside the context of internal decision-making and the absence of participant consent for external data sharing. The data are being used to support ongoing product development and regulatory interactions.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07050511
- Acronym / sponsor ID
- GB-0669-101
- Conditions
- SARS CoV-2
- Keywords
- SARS CoV-2, GB-0669
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Generate BiomedicinesIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Intervention GB-0669 | Experimental | Drug: GB-0669Study intervention |
| Placebo | Placebo comparator | Drug: Placebosterile 0.9% (w/v) sodium chloride solution |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects
- Adults, 18 to 55 years of age (inclusive) at screening
- Body mass index (BMI) ≥ 19.0 and ≤ 35.0 kg/m2
- Medically healthy without clinically significant abnormalities at screening and pre-dose on Day 1
- Negative SARS-CoV-2 rapid antigen or PCR tests prior to randomization
Key exclusion criteria (17 listed)
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, oncological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease, including any acute illness or surgery within the past 3 months determined by the principal investigator (PI) to be clinically relevant. Subjects with localized cancers treated with curative intent and not on active therapy are allowed
- Current infection that requires antibiotic, antifungal, antiparasitic or antiviral medications
- Acute illness or fever within 3 days before study enrollment (enrollment may be delayed for full recovery if acceptable to the investigator)
- Abnormal EKG or any known cardiac condition determined by the PI to be clinically Current infection that requires antibiotic, antifungal, antiparasitic or antiviral medications
- Positive testing for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C antibodies (HCV)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GB-0669Single IV infusion of GB-0669. | Drug | Study Intervention GB-0669 |
| PlaceboSingle IV infusion of placebo. Sterile 0.9% (w/v) sodium chloride solution. | Drug | Placebo |
Primary outcome
To assess the safety and tolerability of a single ascending dose of GB-0669 administered intravenously in healthy volunteers
Time frame: Day -1 to Day 302
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).
8 secondary outcomes
To characterize the maximum concentration (Cmax) of GB-0669 following single doses of GB-0669 administered intravenously in healthy volunteers
Time frame: Day 1 to Day 302
To characterize the time to peak drug concentration (Tmax) of GB-0669 following single doses of GB-0669 administered intravenously in healthy volunteers
Time frame: Day 1 to Day 302
To characterize the half-life (t1/2) of GB-0669 following single doses of GB-0669 administered intravenously in healthy volunteers
Time frame: Day 1 to Day 302
To characterize the area under the curve to last quantifiable timepoint (AUClast) of GB-0669 following single doses of GB-0669 administered intravenously in healthy volunteers
Time frame: Day 1 to Day 302
To characterize the volume of distribution (V/F) of GB-0669 following single doses of GB-0669 administered intravenously in healthy volunteers
Time frame: Day 1 to Day 302
To characterize the area under the plasma concentration- time curve (AUC) of GB-0669 following single doses of GB-0669 administered intravenously in healthy volunteers
Time frame: Day 1 to Day 302
To characterize the total body clearance from plasma (CL/F) of GB-0669 following single doses of GB-0669 administered intravenously in healthy volunteers
Time frame: Day 1 to Day 302
To characterize the area under the plasma concentration-time curve from time zero to infinity (AUCinf) of GB-0669 following single doses of GB-0669 administered intravenously in healthy volunteers
Time frame: Day 1 to Day 302
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No. This study was a Phase 1 trial conducted in healthy volunteers to assess safety and pharmacokinetics. Individual participant data will not be shared due to the limited clinical relevance of the data outside the context of internal decision-making and the absence of participant consent for external data sharing. The data are being used to support ongoing product development and regulatory interactions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GB-0669 in people with SARS CoV-2, run by Generate Biomedicines at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability of a single ascending dose of GB-0669 administered intravenously in healthy volunteers (time frame: Day -1 to Day 302). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.