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A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of SPR206 in Healthy Volunteers

NCT03792308 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2020-01-10

No results posted yet for this study

Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single and multiple intravenous doses of SPR206 when administered to healthy adult volunteers.

Conditions

  • Healthy Volunteers

Interventions

DRUG

SPR206

SAD Cohorts: Double-blind dosing will occur in Cohorts 1 - 8. Six participants will receive single doses of SPR206. The dose escalation steps may be altered following review of the safety data upon completion of each cohort. MAD Cohorts: Double blind dosing will occur in Cohorts 9 - 13. Six participants in each cohort will receive multiple doses of SPR206. The dose escalation steps may be altered following review of the safety data upon completion of each cohort. Dosing will commence on the morning of Day 1. Three doses will be administered per day at approximately 8 hours apart. Daily dosing will continue for a total of 7 consecutive days for Cohorts 9 - 12 and for a total of 14 consecutive days for Cohort 13.

DRUG

Placebo

0.9% sodium chloride for injection. SAD Cohorts: Two participants in each cohort will receive matching placebo. MAD Cohorts: Two participants in each cohort will receive matching placebo.

Sponsors & Collaborators

  • Clinical Network Services (CNS) Pty Ltd

    collaborator INDUSTRY

  • Spero Therapeutics

    lead INDUSTRY

Principal Investigators

  • James Kuo, MBBS, B Med Sci, FRACP · Scientia Clinical Research Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-18
Primary Completion
2019-12-23
Completion
2019-12-23

Countries

  • Australia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03792308 on ClinicalTrials.gov