Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Dose of GV101 in Healthy Subjects

NCT05068947 | Completed Phase 1 FDA Drug

• 1 other identifier: GBS-101
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center Phase 1, placebo-controlled, randomized, double blind, first-in-human (FIH), sequential single ascending dose (SAD) study.

Conditions

Phase 1

Keywords

Healthy; Adult; Volunteers

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to day 7.

Secondary Outcomes (1)

• GV101 plasma levels will be quantified for PK analysis

  Cohort 5 -7: pre-dose and 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hrs post dose.

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

GV101 DRUG

GV101 administered once orally.

Study drug: GV101

Placebo DRUG

Matched placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing and able to
• a) 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:
• b) The absence of clinically significant history and condition of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease
• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Graviton Bioscience Corporation: lead

Study Sites (1)

Clinical Pharmacology of Miami

Hialeah, Florida, 33014, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3:1 GV101 (study drug) to placebo. (1:1 for sentinel 2 subjects and 5:1 thereafter)

Study Record Dates

• First Submitted: September 26, 2021
• First Posted: October 6, 2021
• Study Start: September 10, 2021
• Primary Completion: October 22, 2021
• Study Completion: October 22, 2021
• Last Updated: October 17, 2023

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)