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Study of OsrhAAT or Placebo in Healthy Volunteers

NCT05315921 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-12-12

No results posted yet for this study

Summary

A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Single Ascending Doses of OsrhAAT in Healthy Volunteers

Conditions

  • Emphysema Secondary to Congenital AATD

Interventions

DRUG

OsrhAAT 1 mg/kg IV

Drug: OsrhAAT 1 mg/kg IV A single dose of OsrhAAT 1 mg/kg IV infusion at a rate approximately 0.04 ml/min/kg. Placebo: Normal Saline (0.9% Sodium Chloride)

DRUG

OsrhAAT 3 mg/kg IV

Drug: OsrhAAT 3 mg/kg IV A single dose of OsrhAAT 3 mg/kg IV infusion at a rate approximately 0.04 ml/min/kg. Placebo: Normal Saline (0.9% Sodium Chloride)

DRUG

OsrhAAT 10 mg/kg IV

Drug: : OsrhAAT 10 mg/kg IV A single dose of OsrhAAT 10 mg/kg IV infusion at a rate approximately 0.04 ml/min/kg. Placebo: Normal Saline (0.9% Sodium Chloride)

DRUG

OsrhAAT 20 mg/kg IV

Drug: OsrhAAT 20 mg/kg IV A single dose of OsrhAAT 20 mg/kg IV infusion at a rate approximately 0.04 ml/min/kg. Placebo: Normal Saline (0.9% Sodium Chloride)

DRUG

OsrhAAT 40 mg/kg IV

Drug: OsrhAAT 40 mg/kg IV A single dose of OsrhAAT 40 mg/kg IV infusion at a rate approximately 0.04 ml/min/kg. Placebo: Normal Saline (0.9% Sodium Chloride)

DRUG

OsrhAAT 60 mg/kg IV

Drug: OsrhAAT 60 mg/kg IV A single dose of OsrhAAT 60 mg/kg IV infusion at a rate approximately 0.04 ml/min/kg. Placebo: Normal Saline (0.9% Sodium Chloride)

Sponsors & Collaborators

  • Healthgen Biotechnology Corp.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-03-22
Primary Completion
2023-03-31
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05315921 on ClinicalTrials.gov