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Multiple Dose Study of Safety and Pharmacokinetics of MEDI0618 in Healthy Volunteers

NCT05714254 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-01-05

No results posted yet for this study

Summary

This is a single centre, randomised, double-blind, placebo-controlled, multiple ascending dose study of MEDI0618 in healthy male and female volunteers.

Subjects will receive MEDI0618 or placebo administered by intravenous infusion or subcutaneous injection.

Safety, tolerability and pharmacokinetics of multiple ascending doses of MEDI0618 will be assessed.

Conditions

Interventions

DRUG

MEDI0618

Four doses of 100 mg IV, 200 mg IV or 200 mg SC MEDI0618 administered once every two weeks.

DRUG

Placebo

Four doses of IV placebo or SC placebo administered once every two weeks.

Sponsors & Collaborators

Principal Investigators

  • Stanislav Ignatenko · Charite Research Organisation, Berlin Germany

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-12-12
Primary Completion
2023-12-12
Completion
2023-12-12

Countries

  • Germany

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 NCT05714254 on ClinicalTrials.gov