| Eligibility |
Inclusion Criteria:
- The following inclusion criteria must be met for a subject to be eligible for
inclusion in the study:
1. Status : Healthy subject
2. Gender : Male or female
3. Age : 18 to 50 years, inclusive, at screening
4. Body mass index (BMI) : 18.0 to 30.0 kg/m2, inclusive, at screening
5. Weight : 50 to 105 kg, inclusive, at screening
6. At screening, females must be non-pregnant and non-lactating, or of non
childbearing potential (either surgically sterilized or physiologically incapable
of becoming pregnant, or at least 1 year post menopausal [amenorrhoea duration of
12 consecutive months]); non-pregnancy will be confirmed for all females by a
serum pregnancy test conducted at screening, admission to the CPU, and follow up.
7. Post-menopausal females using hormone replacement therapy should be on a stable
regimen and be using this since at least 3 months prior to the first study drug
administration.
8. Female subjects of childbearing potential who have a fertile male sexual partner
must agree to use adequate contraception from screening until 90 days after the
follow up visit. Adequate contraception will be methods with low user dependency
(ie, implanted hormonal contraception, an intrauterine device, an intrauterine
hormone releasing system, bilateral tubal occlusion, and/or a sole vasectomised
male partner with medical assessment). Also, total abstinence, in accordance with
the lifestyle of the subject, is acceptable.
9. Male subjects, if not surgically sterilized, must agree to use adequate
contraception when engaging in sexual activity with a female of childbearing
potential and not to donate sperm from admission to the CPU until 90 days after
the follow-up visit. Adequate contraception for the male subject (and his female
partner) will be methods with low user dependency (ie, implanted hormonal
contraception, an intrauterine device, an intrauterine hormone releasing system,
bilateral tubal occlusion, and/or a sole vasectomised male subject with medical
assessment). Also, total abstinence, in accordance with the lifestyle of the
subject, is acceptable.
10. All prescribed medication must have been stopped at least 30 days prior to
admission to the CPU. An exception is made for hormonal contraceptives and a
stable regimen of hormone replacement therapy, which may be used throughout the
study.
11. All over-the-counter medication, vitamin preparations and other food supplements,
or herbal medications (eg, St. John's Wort) must have been stopped at least 14
days prior to admission to the CPU. An exception is made for paracetamol, which
is allowed up to admission to the CPU.
12. Ability and willingness to abstain from alcohol, methylxanthine-containing
beverages or food (coffee, tea, cola, chocolate, energy drinks), and grapefruit
(juice) from 48 hours prior to admission to the CPU.
13. Good physical and mental health on the basis of medical history, physical
examination, clinical laboratory, ECG, and vital signs, as judged by the
Investigator.
14. Willing to comply with the study procedures.
15. Willing and able to sign the ICF.
Exclusion Criteria:
A subject who meets any of the following exclusion criteria will not be eligible
for inclusion in the study:
1. Previous participation in the current study.
2. Employee of PRA Health Sciences (PRA), Hammersmith Medicines Research Ltd. (HMR),
or Tetraphase Pharmaceuticals, Inc.
3. Subjects who may not tolerate a BAL, or cannot undergo a BAL due to the presence
of contraindications to a BAL (including abnormal blood coagulation parameters,
refractory hypoxemia, reactive airway disease or asthma, unstable angina or acute
myocardial infarction in the 6 months prior to the first study drug
administration).
4. History of any relevant lung disease.
5. History of relevant drug (including tetracycline-class antibiotics) and/or food
allergies.
6. Using tobacco products or electronic cigarettes within 6 months prior to the
first study drug administration.
7. History of alcohol abuse or drug addiction (including soft drugs like cannabis
products) within 2 years prior to the first study drug administration.
8. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines
[including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic
antidepressants, cotinine, and alcohol) at screening and admission to the CPU.
9. Average intake of more than 24 units of alcohol per week: 1 unit of alcohol
equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).
10. Positive screen for hepatitis B surface antigen (HBsAg), antihepatitis C virus
(HCV) antibodies, or antihuman immunodeficiency virus (HIV) 1 and 2 antibodies.
11. Participation in a drug study within 60 days prior to the first study drug
administration in the current study. Participation in more than 3 other drug
studies in the 10 months prior to the first study drug administration in the
current study.
12. Donation or loss of more than 400 mL of blood within 90 days prior to the first
study drug administration. Donation or loss of more than 1.5 liters of blood (for
male subjects)/more than 1.0 liters of blood (for female subjects) in the 10
months prior to the first study drug administration in the current study.
13. Significant and/or acute illness within 5 days prior to the first study drug
administration that may impact safety assessments, in the opinion of the
Investigator.
14. Unsuitable veins for infusion or blood sampling.
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