Safety Study of VBY-036 in Healthy Volunteers After 7 Days of Oral Dosing (VBY036P1B)



Status and phase

Phase 1




Drug: VBY-036

Study type


Funder types




Details and patient eligibility


VBY-036 may treat or prevent nerve pain. This study aims to find the highest safe and tolerable dose of VBY-036 in healthy volunteers. Volunteers will be randomly selected to receive either a placebo or VBY-036 (30, 100, 300, 600 or 900 mg) once daily for seven days in a row.

Full description

Detailed description is noted in Brief Summary.


40 patients




18 to 60 years old


Accepts Healthy Volunteers

Inclusion criteria

  • Male or female, 18-60 years old
  • Screening body mass index between 18-32 kg/m2
  • Good health, no clinically significant findings in medical history, 12-lead ECG, & vital signs;
  • Clinical lab evaluations (Chem panel [fasted at least 8 hrs], CBC, HbA1c & UA in reference range for test lab (unless deemed not clinically significant);
  • Negative test for drugs of abuse at Screening & at Check-in (includes alcohol);
  • Negative hepatitis, HIV & TB screens;
  • Females non-pregnant, non-lactating, & either postmenopausal for at least 1 year, surgically sterile for at least 90 days prior to Check-in, or agree to use from the time of consent until 90 days after Study Completion an effective form of contraception. For all females, a pregnancy test result must be negative at Screening & Check-in.
  • Males will be sterile or agree to use from Check-in until 90 days following discharge an effective method of contraception.
  • Able to comprehend & willing to sign Informed Consent Form

Exclusion criteria

  • Females pregnant or nursing, or childbearing potential but unwilling to use contraception.
  • History of renal or hepatic impairment; stomach or intestinal surgery or resection, malabsorption syndrome, cholecystectomy, or gastro-intestinal dysfunction that would alter absorption &/or excretion of orally administered drugs (appendectomy or hernia repair allowed);
  • Anemia (hemoglobin <11.5 g/dL for females; < 13 g/dL for males) or blood donation within 8 weeks of Check-in;
  • Plasma donation within 4 weeks of Check-in;
  • History of alcoholism or drug addiction within 6 months to Check-in;
  • Use of drugs of abuse or prescription drugs for recreational use 6 months prior to Check-in;
  • Use of any tobacco-containing or nicotine-containing products 6 months prior to Check-in & during study;
  • Participation in another drug trial 30 days of Check-in (within 8 weeks if previous investigational drug has immunomodulary effects, other than cathepsin S inhibition);
  • History or clinical manifestations of metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders
  • History of hypersensitivity or allergies to any drug compound
  • History or presence of abnormal ECG
  • Laboratory abnormality deemed clinically significant;
  • Use of or inability to discontinue any prescription medications/products 14 days prior to Check-in & during study;
  • Use of certain over-the-counter, non-prescription preparations are permitted up to 3 days before first dose;
  • Use of alcohol-containing, grapefruit-containing, star fruit containing foods or beverages or "energy drinks" 72 hours to Check-in & during study;
  • Poor peripheral venous access;
  • Receipt of blood products 6 months to Check-in
  • Subjects with history of Gilbert's Syndrome;
  • Strenuous activities 48 hours to Check-in
  • Illness 5 days to drug administration
  • Any acute or chronic condition

Trial design

Primary purpose




Interventional model

Single Group Assignment


Triple Blind

40 participants in 2 patient groups, including a placebo group

Experimental group
VBY-036 30 mg, 100 mg, 300 mg, 600 mg, or 900 mg
Drug: VBY-036
Placebo comparator
Placebo Comparator group

Trial contacts and locations



Data sourced from

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