All > Emphysema

OsrhAAT 1 mg/kg IV for Emphysema

Altasciences, Cypress, CA
Emphysema+1 More ConditionsOsrhAAT 1 mg/kg IV - Drug
Eligibility
18 - 55
All Sexes
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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
  • Alpha-1 Antitrypsin Deficiency

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 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.

Day 180
Safety and tolerability: Incidence of adverse events (AEs), serious adverse events (SAEs), and infusion site reactions

Trial Safety

Phase-Based Safety

1 of 3

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1
isatuximab 10 mg/kg
1
ZTI-01 100 mg/kg
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

6 Treatment Groups

OsrhAAT 1 mg/kg IV
1 of 6
OsrhAAT 3 mg/kg IV
1 of 6
OsrhAAT 10 mg/kg IV
1 of 6
OsrhAAT 20 mg/kg IV
1 of 6
OsrhAAT 40 mg/kg IV
1 of 6
OsrhAAT 60 mg/kg IV
1 of 6

Experimental Treatment

48 Total Participants · 6 Treatment Groups

Primary Treatment: OsrhAAT 1 mg/kg IV · No Placebo Group · Phase 1

OsrhAAT 1 mg/kg IV
Drug
Experimental Group · 1 Intervention: OsrhAAT 1 mg/kg IV · Intervention Types: Drug
OsrhAAT 3 mg/kg IV
Drug
Experimental Group · 1 Intervention: OsrhAAT 3 mg/kg IV · Intervention Types: Drug
OsrhAAT 10 mg/kg IV
Drug
Experimental Group · 1 Intervention: OsrhAAT 10 mg/kg IV · Intervention Types: Drug
OsrhAAT 20 mg/kg IV
Drug
Experimental Group · 1 Intervention: OsrhAAT 20 mg/kg IV · Intervention Types: Drug
OsrhAAT 40 mg/kg IV
Drug
Experimental Group · 1 Intervention: OsrhAAT 40 mg/kg IV · Intervention Types: Drug
OsrhAAT 60 mg/kg IV
Drug
Experimental Group · 1 Intervention: OsrhAAT 60 mg/kg IV · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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.

Who is running the clinical trial?

Healthgen Biotechnology Corp.Lead Sponsor
2 Previous Clinical Trials
261 Total Patients Enrolled

Eligibility Criteria

Age 18 - 55 · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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