A Safety and PK Study of IV Eravacycline

This is a Phase 1, open-label, single dose study to evaluate PK, safety, and tolerability of
IV eravacycline in children with suspected or confirmed bacterial infection who are receiving
systemic antibiotic therapy, other than eravacycline. The study design will allow for
evaluation of PK and safety of IV eravacycline in a pediatric population at exposures
predicted to be comparable to those already studied in adults. The study design is depicted
in Figure 1.

Two cohorts defined by age group will be enrolled simultaneously:

- Cohort 1: 12 to <18 years of age (adolescents)

- Cohort 2: 8 to <12 years of age (younger children) Eravacycline will be administered as
a single IV dose using the optimum dosage determined from PK-PD modeling and model-based
simulations of phase 1, 2, and 3 adult data. Blood samples will be collected for PK
analysis at predetermined timepoints.

Inclusion Criteria:

1. Male or female from 8 to <18 years of age on the day informed consent (and assent, if
applicable) is obtained

2. Written informed consent from parent(s) or other legally authorized representative(s)
and informed assent from subject (if age appropriate according to local requirements)

3. Hospitalized, in stable condition, and receiving or plan to receive within 24 hours
systemic antibiotic therapy, other than eravacycline, for a suspected or confirmed
bacterial infection

4. Likely to survive the current illness

5. In the Investigator's opinion, the subject will require hospitalization for at least
24 hours following administration of the study drug

6. The subject appears to have sufficient intravascular access (peripheral or central) to
receive study drug

Exclusion Criteria:

1. Male or female from 8 to <18 years of age on the day informed consent (and assent, if
applicable) is obtained

2. Written informed consent from parent(s) or other legally authorized representative(s)
and informed assent from subject (if age appropriate according to local requirements)

3. Hospitalized, in stable condition, and receiving or plan to receive within 24 hours
systemic antibiotic therapy, other than eravacycline, for a suspected or confirmed
bacterial infection

4. Likely to survive the current illness

5. In the Investigator's opinion, the subject will require hospitalization for at least
24 hours following administration of the study drug

6. The subject appears to have sufficient intravascular access (peripheral or central) to
receive study drug

7. Subject is a child of an employee of the Investigator or study center who has direct
involvement in the proposed study or other studies under the direction of the same
Investigator or study center, or an immediate family member of the employee or the
Investigator, defined as a spouse, parent, child, or sibling, whether biological or
legally adopted

8. Breastfeeding females

9. Females of childbearing potential [those with menarche and/or thelarche (beginning of
breast development)] and sexually active males who are unwilling or unable to use an
acceptable method of contraception

10. Positive pregnancy test in females of childbearing potential

11. Any other circumstance that, in the opinion of the Investigator, would preclude
subject participation in the study