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Study to Evaluate Safety and PK of NTM-1634 vs Placebo Administered Intravenously in Healthy Adults

NCT03046550 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-02-05

No results posted yet for this study

Summary

This study evaluates the safety and pharmacokinetics of NTM-1634 in healthy subjects.

Conditions

  • Healthy

Interventions

DRUG

NTM-1634

NTM-1634 drug product is a mixture of four human monoclonal IgG1 antibodies. Three dose cohorts (A: 0.33 mg/kg B: 0.66 mg/kg, and C: 1 mg/kg).

DRUG

Placebo

placebo

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Alachua Government Services, Inc.

    lead INDUSTRY

Principal Investigators

  • Dennis Ruff, MD · ICON Early Phase Services, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2017-10-30
Completion
2017-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03046550 on ClinicalTrials.gov