Phase 1Phase 1NCT05068947
Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Dose of GV101 in Healthy Subjects
A Phase 1 study testing GV101 in people with Phase 1, run by Graviton Bioscience Corporation at 1 site in United States.
Trial summary
This is a single center Phase 1, placebo-controlled, randomized, double blind, first-in-human (FIH), sequential single ascending dose (SAD) study. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Phase 1
- What is being tested?
- GV101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2021to 22 Oct 2021
- 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
- Willing and able to
- communicate in English or Spanish b) provide written informed consent to take part in the study c) be available for all visits and able and willing to comply with all study procedural requirements
- Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥ 18 and ≤ 55 years of age, with BMI > 18.5 and < 30.0 kg/m2 and body weight within 50 kg and 100 kg for males and 45 kg and 100 kg for females.
- Healthy, as defined by:
- The absence of clinically significant illness or surgery within 4 weeks of dosing. Subjects vomiting within 24 hours before the first study drug administration will be carefully evaluated for possible illness/disease and inclusion is at the discretion of the Investigator.
- The absence of clinically significant history and condition of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease
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- Women (sex at birth) Pre-menopausal women (not post-menopausal: absence of menses for at least 12 months and a medical history consistent with menopause) engaging in heterosexual sex that could lead to pregnancy must be willing to use an effective method of contraception for 4 weeks prior to taking the study drug, throughout the study and until 30 days following the last study drug intake: Acceptable methods are:
- condom used together with another barrier method (diaphragm or cervical cap with spermicide), hormonal method started at least 8 weeks before dosing, or an IUD in place for at least 8 weeks
- sterilization of participant or partner (male vasectomized for at least 6 months)
- Men (sex at birth) Heterosexually active men are required to use an effective method of contraception for 4 weeks prior to taking the study drug, throughout the study and until 90 days following the last study drug intake: Acceptable methods are:
- condom used together with another barrier method (diaphragm or cervical cap with spermicide), hormonal method started at least 8 weeks before dosing, or an IUD in place for at least 8 weeks
- sterilization of participant or partner (male vasectomized for at least 6 months)
- Male subjects must commit to not donate sperm until at least 90 days following study drug administration even if vasectomized.
- Male subjects of a pregnant partner must use a condom from study drug administration until 90 days afterwards, even if the male partner has been vasectomized.
- -
Who cannot join
- Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for hepatitis B, hepatitis C, or HIV found during medical screening
- Evidence of hepatic or renal impairment including ALT and AST above 1.5 x ULN, total bilirubin above 1.5 x ULN, or creatinine above 1.5 x ULN.
- Positive urine cotinine or positive urine drug screen at screening or baseline
- History of anaphylaxis, or history of moderate or worse allergic reaction to oral drug excipients
- History of clinically significant gastrointestinal diseases or surgery which might influence drug absorption
- Positive pregnancy test at screening or baseline
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- Received a COVID-19 vaccine within 7 days of the baseline visit
- Positive COVID-19 PCR test at screening or baseline
- Clinically significant ECG abnormalities (QTcF ≥ 450 ms)
- Clinically significant vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening or baseline. In cases of abnormal vital signs, tests can be repeated at the investigator's discretion.
- History of substance abuse within 6 months before admission (with the exception of medically indicated marijuana), including alcohol
- Use of an investigational drug or device or participation in an investigational study within 30 days prior to admission
- Use of medications in the timeframes specified below, with the exception of medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or subject safety (e.g., topical drug products without significant systemic absorption):
- Prescription medications taken within 14 days prior to dosing
- Over-the-counter and natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals amino acids, essential fatty acids, and protein supplements used in sports) taken within 7 days prior to dosing, with the exception of the occasional use of acetaminophen (up to 2 g daily)
- Depot injection or implant of any drug within 3 months prior to dosing
- Use of any drugs known to induce or inhibit hepatic drug metabolism (including St. John's Wort [hypericin]) within 30 days prior to dosing.
- Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to dosing
- Breast feeding
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Pharmacology of Miami
Hialeah, Florida, 33014
About this study
Official title: Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Dose of GV101 in Healthy Subjects.
This is a single center Phase 1, placebo-controlled, randomized, double blind, first-in-human (FIH), sequential single ascending dose (SAD) study.
Read the detailed description
GBS-101 is a single center Phase 1, placebo-controlled, randomized, double blind, first-in-human (FIH), sequential single ascending dose (SAD) study to evaluate the safety, tolerability and PK of GV101 in healthy subjects. 8 healthy subjects wills be enrolled cohorts 5 - 7 cohorts of the study. Cohorts 1-4 were previously completed with a tablet form of the study drug at 50 mg, 100 mg, 200 mg, and 400 mg. Planned cohorts 5 - 7 will be dosed 400 mg (liquid), 800 mg (liquid), 1600 mg (liquid) or matched placebo.. Participants will be randomized in a 3:1 ratio, 1:1 for 2 sentinel subjects and 5: 1 GV101 drug to matching placebo thereafter. Subjects in each cohort will receive a single oral dose of GV101 or matching placebo under fasting conditions. A staggered schedule will be used for each dose level, where 2 sentinel subjects (1 active and 1 placebo) will be dosed first, with the remaining 6 subjects (5 active and 1 placebo) dosed at least 24 hours after the sentinel subjects.
This study of GV101 will provide safety, tolerability, and plasma pharmacokinetic data in healthy individuals. The PK component will characterize the PK of GV101 to inform dosing and may help to correlate exposures treatment-related AEs.
- Conditions
- Phase 1
- Being tested
- GV101, Placebo
- Keywords
- Healthy, Adult, Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GV101Drug
GV101 administered once orally.
PlaceboDrug
Matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Study drug: GV101 | Experimental | 400 mg (10 mL liquid), 800 mg (20 mL liquid), 1600 mg (40mL liquid) of GVS101 will be administered once, orally to subjects in the treatment group, cohort 5 to 7. Receives: Drug: GV101 |
| Placebo | Placebo comparator | Matched placebo control 400 mg (10 mL liquid), 800 mg (20 mL liquid), 1600 mg (40mL liquid) of GVS101 will be administered once, orally to subjects in the control group, cohort 5 to 7. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent AEs
Number of TEAEs grade 2 or higher per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
Measured: Up to day 7.
Secondary outcomes (1)
GV101 plasma levels will be quantified for PK analysis
Measured: Cohort 5 -7: pre-dose and 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hrs post dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start10 Sep 2021
- Primary completion22 Oct 2021
- Study completion22 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phase 1Studies 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
- Randomised
- Intervention model
- Sequential
- Model description
- 3:1 GV101 (study drug) to placebo. (1:1 for sentinel 2 subjects and 5:1 thereafter)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Graviton Bioscience Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068947
- Sponsor's protocol ID
- GBS-101
- Status last verified
- Sep 2021
- First submitted
- 26 Sep 2021
- Last updated
- 17 Oct 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Dose of GV101 in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT05068947
- Acronym / sponsor ID
- GBS-101
- Conditions
- Phase 1
- Keywords
- Healthy, Adult, Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Graviton Bioscience CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 22 Oct 2021 (actual)
- Study completion
- 22 Oct 2021 (actual)
- First posted
- 6 Oct 2021 (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.
This is a single center Phase 1, placebo-controlled, randomized, double blind, first-in-human (FIH), sequential single ascending dose (SAD) study.
Detailed description
GBS-101 is a single center Phase 1, placebo-controlled, randomized, double blind, first-in-human (FIH), sequential single ascending dose (SAD) study to evaluate the safety, tolerability and PK of GV101 in healthy subjects. 8 healthy subjects wills be enrolled cohorts 5 - 7 cohorts of the study. Cohorts 1-4 were previously completed with a tablet form of the study drug at 50 mg, 100 mg, 200 mg, and 400 mg. Planned cohorts 5 - 7 will be dosed 400 mg (liquid), 800 mg (liquid), 1600 mg (liquid) or matched placebo.. Participants will be randomized in a 3:1 ratio, 1:1 for 2 sentinel subjects and 5: 1 GV101 drug to matching placebo thereafter. Subjects in each cohort will receive a single oral dose of GV101 or matching placebo under fasting conditions. A staggered schedule will be used for each dose level, where 2 sentinel subjects (1 active and 1 placebo) will be dosed first, with the remaining 6 subjects (5 active and 1 placebo) dosed at least 24 hours after the sentinel subjects.
This study of GV101 will provide safety, tolerability, and plasma pharmacokinetic data in healthy individuals. The PK component will characterize the PK of GV101 to inform dosing and may help to correlate exposures treatment-related AEs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 3:1 GV101 (study drug) to placebo. (1:1 for sentinel 2 subjects and 5:1 thereafter)
| Arm | Type | Receives |
|---|---|---|
| Study drug: GV101 | Experimental | Drug: GV101400 mg (10 mL liquid), 800 mg (20 mL liquid), 1600 mg (40mL liquid) of GVS101 will be administered once, orally to subjects in the treatment group, cohort 5 to 7. |
| Placebo | Placebo comparator | Drug: PlaceboMatched placebo control 400 mg (10 mL liquid), 800 mg (20 mL liquid), 1600 mg (40mL liquid) of GVS101 will be administered once, orally to subjects in the control group, cohort 5 to 7. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Willing and able to
- Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥ 18 and ≤ 55 years of age, with BMI > 18.5 and < 30.0 kg/m2 and body weight within 50 kg and 100 kg for males and 45 kg and 100 kg for females.
- Healthy, as defined by:
- Women (sex at birth) Pre-menopausal women (not post-menopausal: absence of menses for at least 12 months and a medical history consistent with menopause) engaging in heterosexual sex that could lead to pregnancy must be willing to use an effective method of contraception for 4 weeks prior to taking the study drug, throughout the study and until 30 days following the last study drug intake: Acceptable methods are:
- Men (sex at birth) Heterosexually active men are required to use an effective method of contraception for 4 weeks prior to taking the study drug, throughout the study and until 90 days following the last study drug intake: Acceptable methods are:
Key exclusion criteria (21 listed)
- Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for hepatitis B, hepatitis C, or HIV found during medical screening
- Evidence of hepatic or renal impairment including ALT and AST above 1.5 x ULN, total bilirubin above 1.5 x ULN, or creatinine above 1.5 x ULN.
- Positive urine cotinine or positive urine drug screen at screening or baseline
- History of anaphylaxis, or history of moderate or worse allergic reaction to oral drug excipients
- History of clinically significant gastrointestinal diseases or surgery which might influence drug absorption
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 |
|---|---|---|
| GV101GV101 administered once orally. | Drug | Study drug: GV101 |
| PlaceboMatched placebo | Drug | Placebo |
Primary outcome
Treatment emergent AEs
Time frame: Up to day 7.
Number of TEAEs grade 2 or higher per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
1 secondary outcome
GV101 plasma levels will be quantified for PK analysis
Time frame: Cohort 5 -7: pre-dose and 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hrs post dose.
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 17 Oct 2023.
- Individual participant dataSharing planned: No
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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 GV101 in people with Phase 1, run by Graviton Bioscience Corporation 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 15 inclusion and 21 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 17 Oct 2023. 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?
Treatment emergent AEs (time frame: Up to day 7.). 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 17 Oct 2023.