NCT03046550

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

A Phase I, Double-Blind, Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of NTM-1634 vs Placebo Administered Intravenously in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Alachua Government Services, Inc. · Industry
• Sex: All
• Age: 18 Years – 48 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

NTM-1634 drug product is a mixture of four human monoclonal IgG1 antibodies. This study is a randomized, double-blind, placebo controlled dose escalation study of three dose cohorts. Cohort A: 0.33mg/kg; B: 0.66mg/kg; and C: 1 mg/kg.

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-03-20
• Primary completion: 2017-10-30
• Completion: 2017-10-30
• First posted: 2017-02-08
• Last updated: 2020-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study