A Study to Assess the Safety, Tolerability and Pharmacokinetics of BSG005.

Last updated: November 17, 2022
Sponsor: Biosergen AS
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04921254
BSG1.01
  • Ages 18-55
  • Male
  • Accepts Healthy Volunteers

Study Summary

A Phase 1, double-blinded, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics of BSG005 following single and multiple ascending doses in healthy subjects. The study will include a single ascending dose part and a multiple ascending dose part

Eligibility Criteria

Inclusion

Inclusion Criteria: To be included in this study, each individual must satisfy all the following criteria:

  1. Male adult subjects aged 18 - 55 years at screening.
  2. Subjects without concurrent illnesses who do not require any medical treatments.
  3. Judged by an Investigator to be in good health as documented by the medical history,physical examination (including but may not be limited to an evaluation of thecardiovascular, gastrointestinal, respiratory, and central nervous systems), 12-leadECG, vital sign assessments, clinical laboratory assessments, and by generalobservations. Any abnormalities or deviations outside the normal ranges for any ofclinical testing (laboratory tests, ECG, vital signs) can be repeated at thediscretion of the Investigator(s) and/or judged to be not clinically significant forstudy participation.
  4. Body Mass Index ≥18 and <30 kg/m2 and a weight of at least 50 kg.
  5. Negative drug and alcohol screen in urine. Negative pregnancy test (females)
  6. Subject is a non-smoker or smokes ≤ 10 cigarettes per day (or equivalent).
  7. Must be able and willing to provide written informed consent.
  8. Are willing to remain in the study unit for the entire duration of the treatmentperiod, attend all scheduled visits, and comply with all study procedures.
  9. If sexually active males, must use a condom OR abstinence OR same sex partner ORsurgically sterile OR partner is of non-childbearing potential.

Exclusion

Exclusion Criteria: If an individual meets any of the following criteria, he or she is ineligible for thisstudy:

  1. Participation in any study involving an investigational drug or device within the past 30 days or ongoing participation in a study with an investigational drug or device.
  2. Any clinical evidence that the Investigator feels would place the subject at increasedrisk with the investigational product.
  3. Subject shows clinically significant abnormalities in physical examination, vitalsigns, 12-lead ECG, or clinical laboratory parameters for the screening assessments (especially for liver enzymes, and serum creatinine and estimated creatinineclearance) according to the Investigator's judgment.
  4. Has liver enzyme results (AST, ALT, GGT) above the upper normal limit (UNL): AST 37U/L; ALT 78 U/L; GGT 55 U/L.
  5. Has a creatinine value outside the normal range (female <0.51 mg/dL; male <0.67 mg/dL)and an estimated creatinine clearance (Cockcroft-Gault) < 30 mL/min
  6. Subject with, or history of clinically significant neurologic, gastrointestinal,renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine,hematological, or other major disorders.
  7. Subject who has a sitting or lying blood pressure at screening, after resting for atleast 5 minutes: systolic blood pressure > 155 or < 90 mmHg, or diastolic bloodpressure > 90 or < 40 mmHg.
  8. Subject who has a sitting or lying pulse rate at screening, after resting for at least 5 minutes, outside the range of < 39 or > 101 beats/min.
  9. Subject who donated blood or who had a comparable blood loss (approximately 500 mL)during the last 30 days prior to start of this study.
  10. Subject with a known history of clinically significant drug allergies in the opinionof the Investigator or with a known allergy to any medicine chemically related to thestudy medication.
  11. Subject who has had a clinically significant illness within four weeks prior toscreening in the opinion of the Investigator.
  12. Subject with a history of chronic alcohol (regular daily intake of more than, e.g.,three standard drinks) or drug abuse within the last 6 months prior to firstadministration or evidence of such abuse as indicated by the laboratory profileconducted during the screening examination.
  13. Subject who has received prescription drugs or OTC medication other than dietarysupplements, occasional ibuprofen, standard dose vitamins, or herbal products within 2weeks prior to the first administration (with the exception of up to 1000 mgacetaminophen per day).
  14. Subject who plans to take concomitant medications while enrolled in the study (withthe exception of up to 1000 mg acetaminophen per day or vitamins, dietary supplements,or herbal products).
  15. Subject who received any treatment agents known to alter the major organs or systemswithin 30 days prior to the first administration (e.g., diuretics, nephro- or livertoxic medication, barbiturates, phenothiazines, cimetidine, more than 1.0 L ofcaffeine-containing beverages per day, etc.).
  16. Subject who has consumed any grapefruit containing product on the day of cliniccheck-in.

Study Design

Total Participants: 72
Study Start date:
August 23, 2021
Estimated Completion Date:
May 31, 2023

Study Description

The study will investigate the safety and tolerability of BSG005 in healthy subjects. The study will also include pharmacokinetic investigations.

There will be an ascending single dose part (SAD) with 6 subject in a study dose cohort of which 2 will be placebo and 4 will be on active drug. This concept will be replicated in the multiple ascending dose (MAD) part.

There is expected to be up to6 cohorts in SAD part with a starting dose calculated from the GLP NOAEL dose levels and from that increasing dose levels will be tested after a Safety Review Committee (SRC) has approved the escalation to next dose level. The key parameters are infusion reactions, kidney, liver and potassium changes during and after administration of BSG005.

Depending on the outcome of the SAD part the MAD part may include 4 or 5 dose levels administered daily over 7 days. Key parameters are the same as in the SAD part but extended to cover monitoring over 14 days. Pharmacokinetics at day 1 and day 7 will be investigated.

Key evaluation is on safety and tolerability during and after 7 days of dosing and pharmacokinetic investigations and the steady state plasma levels.

Connect with a study center

  • Nucleus Network Pty Ltd

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

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