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Single Ascending Dose Study of MEDI1341 in Healthy Volunteers

NCT03272165 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-06-09

No results posted yet for this study

Summary

This is a study of single ascending intravenous doses of MEDI1341 or placebo in up to 48 healthy volunteers, aged 18 to 65 years. The study will include up to 6 planned cohorts; each cohort will comprise 8 participants.

Each participant will receive a single 60 minute intravenous infusion of MEDI1341 or placebo and will undergo scheduled assessments over a period of 13 weeks.

The main aim of the study is to assess the safety and tolerability of single doses of MEDI1341 in healthy volunteers.

Conditions

Interventions

DRUG

MEDI1341

Participants will receive IV infusion of MEDI1341 doses as stated in the arms' description.

DRUG

Placebo

Participants will receive IV infusion of placebo matched to MEDI1341.

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • MMS Holdings, Inc

    collaborator UNKNOWN

  • Catalent

    collaborator INDUSTRY

  • Takeda

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Jeanelle Kam, MD, CPI · Covance Dallas CRU, USA

  • John E Blanchard, MD · Covance Madison CRU, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-10-17
Primary Completion
2021-03-31
Completion
2021-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT03272165 on ClinicalTrials.gov