Safety and Pharmacokinetics Study of Multiple Ascending Doses of BTA-C585 in Healthy Volunteers

B

Biota Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers
Pharmacokinetics

Treatments

Drug: BTA-C585 oral capsules
Drug: BTA-C585 matching placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02668367
BTA585-002

Details and patient eligibility

About

This is a single center, sequential-cohort, double-blind, placebo-controlled, multiple ascending dose (MAD), 7-day treatment period study in healthy subjects.

Enrollment

36 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Healthy men and women;
  2. Age 18 to 60 years, inclusive;
  3. Weight ≥ 50 kg and Body Mass Index (BMI) of 19 to 32, inclusive;
  4. Female subjects must be of non-childbearing potential;
  5. Male subjects must agree to use a double barrier method of birth control;
  6. Signed informed consent form (ICF) prior to study procedures.

Exclusion criteria

  1. Current or recent (within 14 days of Day 0) bacterial or viral infection;
  2. Positive results at screening for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody;
  3. Clinically significant abnormalities noted on ECG;
  4. Safety laboratory abnormalities;
  5. Regular use of medications, prescription or non-prescription;
  6. Poor vein access or fear of venipuncture or sight of blood;
  7. Major surgery, significant recent injury or trauma within 30 days;
  8. Received an investigational drug or vaccine within 30 days.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

36 participants in 2 patient groups, including a placebo group

BTA-C585 oral capsules
Active Comparator group
Description:
100 mg capsules; Multiple ascending doses (MAD) from 100 mg to 600 mg
Treatment:
Drug: BTA-C585 oral capsules
BTA-C585 matching placebo
Placebo Comparator group
Description:
BTA-C585 Matching placebo capsules; single doses
Treatment:
Drug: BTA-C585 matching placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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