Phase I SAD study for safety, tolerability, PK of IV TP-6076 (117664)
Research type
Research Study
Full title
A Phase I, Randomized, Placebo-Controlled, Double-Blind, Single-Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenous TP-6076 in Healthy Adult Subjects
IRAS ID
200561
Contact name
MaryAlice Worden
Contact email
Sponsor organisation
Tetraphase Pharmaceuticals, Inc.
Eudract number
2016-000336-18
Duration of Study in the UK
0 years, 5 months, 7 days
Research summary
The Sponsor is developing the study drug, TP-6076, for the potential treatment of serious and life-threatening bacterial infections, including those caused by pathogens otherwise resistant to current treatment options. \n\nThe study will evaluate the safety and tolerability of the study drug as well as the impact of the body on the drug (pharmacokinetics), in comparison with the placebo in healthy adult male and female volunteers.\n\nThe study will enrol 4 cohorts of 8 healthy male and female subjects each, with the option to enrol up to 3 additional cohorts of a further 8 subjects each, depending on emergent safety and PK data. In each cohort subjects will be randomly assigned to receive a single intravenous (IV) dose of TP-6076 or matching placebo in a 6:2 ratio. Doses given per cohort will be given in a sequential escalating manner with approximately 2 weeks planned between dose groups. \n\nCohort A will receive 1.8 mg TP-6076 via IV administration, Cohort B will receive 6.0 mg, Cohort C will receive 19.2 mg and Cohort D will receive 60.0 mg. Dose escalation will only proceed following review of safety and pharmacokinetic data from preceding cohort(s). After reviewing the safety and pharmacokinetic data from Cohorts A to D, up to 3 additional cohorts (Cohorts E to G) may be enrolled (dose levels to be confirmed). \n\nFor each cohort subjects will be admitted to the clinic on the evening of Day -2. Baseline procedures will be performed on Day -1. Subjects will be dosed on the morning of Day 1 and will remain resident in the clinic until discharge on Day 5. During this time safety assessments will be performed, and blood and urine samples for pharmacokinetic analysis will be collected. Subjects will return 2 to 5 days after discharge for a follow-up assessment.
REC name
HSC REC A
REC reference
16/NI/0067
Date of REC Opinion
29 Apr 2016
REC opinion
Favourable Opinion