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Protein Replacement Therapy

OsrhAAT 1 mg/kg IV for Emphysema

Phase 1
Waitlist Available
Research Sponsored by Healthgen Biotechnology Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up adverse events (ae) will be collected from the time of informed consent until eos. sae will be collected by the investigator from the informed consent through 180 days.
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and works in healthy volunteers.

Eligible Conditions
  • Alpha-1 Antitrypsin Deficiency (AATD) Emphysema

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~adverse events (ae) will be collected from the time of informed consent until eos. sae will be collected by the investigator from the informed consent through 180 days.
This trial's timeline: 3 weeks for screening, Varies for treatment, and adverse events (ae) will be collected from the time of informed consent until eos. sae will be collected by the investigator from the informed consent through 180 days. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability: Incidence of adverse events (AEs), serious adverse events (SAEs), and infusion site reactions

Trial Design

6Treatment groups
Experimental Treatment
Group I: OsrhAAT 60 mg/kg IVExperimental Treatment1 Intervention
Group II: OsrhAAT 40 mg/kg IVExperimental Treatment1 Intervention
Group III: OsrhAAT 3 mg/kg IVExperimental Treatment1 Intervention
Group IV: OsrhAAT 20 mg/kg IVExperimental Treatment1 Intervention
Group V: OsrhAAT 10 mg/kg IVExperimental Treatment1 Intervention
Group VI: OsrhAAT 1 mg/kg IVExperimental Treatment1 Intervention

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Healthgen Biotechnology Corp.Lead Sponsor
3 Previous Clinical Trials
589 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who does this clinical trial cater to?

"This clinical trial is enrolling 48 patients with aatd aged 18 and 55. Most importantly, patients must meet the following criteria: Able to understand and willing to sign the ICF, No significant medical history, and in good health as determined by detailed medical history (neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease), full physical examination, vital signs, 12-lead electrocardiogram (ECG), urinalysis and laboratory tests at screening. For eligibility purposes, abnormal laboratory or vital signs results may"

Answered by AI

Does the age limit for this experiment extend to those who are younger than 85 years old?

"The age limit for this study is 18-55, as is stated in the inclusion criteria."

Answered by AI

Has the FDA okayed the use of OsrhAAT 1 mg/kg IV?

"OsrhAAT 1 mg/kg IV is being trialled in Phase 1, so there is limited safety data. Our team has given it a score of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of OsrhAAT or Placebo in Healthy Volunteers
2022. "Study of OsrhAAT or Placebo in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05315921.
~16 spots leftby Apr 2025
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