A Phase 1 interventional study of INBRX-101/rhAAT-Fc in Alpha-1 Antitrypsin Deficiency and AATD, sponsored by Inhibrx Biosciences, Inc. Completed at 10 sites in 3 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-09-13.
Sponsored by Inhibrx Biosciences, Inc · Phase 1, Interventional, and Treatment
This is an open-label, 2-part, dose-escalating, Phase 1 study of INBRX-101 (rhAAT-Fc). Part 1 will consist of single ascending dose (SAD) administration of INBRX-101 and Part 2 will consist of multiple ascending dose (MAD) administrations of INBRX-101. The planned dosing schedule is IV every 3 to 4 weeks.
142 studies on the registry are indexed under alpha 1-Antitrypsin Deficiency; 32 are open to participants now.
This study's enrollment of 31 is close to the median of 32 across 86 interventional studies indexed under alpha 1-Antitrypsin Deficiency.
Browse alpha 1-Antitrypsin Deficiency studies →Inhibrx Biosciences, Inc is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INBRX-101 will be escalated in subjects with alpha-1 antitrypsin deficiency (AATD).
Drug: INBRX-101/rhAAT-Fc
INBRX-101 will be escalated in subjects with alpha-1 antitrypsin deficiency (AATD).
Drug: INBRX-101/rhAAT-Fc
INBRX-101 is a recombinant human alpha-1 antitrypsin (AAT) Fc fusion protein (rhAAT-Fc).
Frequency of adverse events of INBRX-101
Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03.
Time frame: Up to 7 months
Severity of adverse events of INBRX-101
Severity of adverse events will be assessed and assigned by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03.
Time frame: Up to 7 months
Area under the serum concentration time curve (AUC) of INBRX-101
Area under the serum concentration time curve (AUC) of INBRX-101 will be determined.
Time frame: Up to 7 months
Maximum observed serum concentration (Cmax) of INBRX-101
Maximum observed serum concentration (Cmax) of INBRX-101 will be determined.
Time frame: Up to 7 months
Trough observed serum concentration (Ctrough) of INBRX-101
Trough observed serum concentration (Cmax) of INBRX-101 will be determined.
Time frame: Up to 7 months
Time to Cmax (Tmax) of INBRX-101
Time to Cmax (Tmax) of INBRX-101 will be determined.
Time frame: Up to 7 months
Half-life (T1/2) of INBRX-101
Half-life of INBRX-101 will be determined.
Time frame: Up to 7 months
Immunogenicity of INBRX-101
Frequency and consequences of anti-drug antibodies (ADA) against INBRX-101 will be determined.
Time frame: Up to 7 months
Distribution of INBRX-101 in Bronchoalveolar Lavage Fluid (BALF)
The concentration of INBRX-101 in bronchoalveolar lavage fluid (BALF) be determined.
Time frame: Up to 7 months
Functional concentration of INBRX-101 in serum and BALF
The functional concentration of INBRX-101 in serum and BALF will be determined.
Time frame: Up to 7 months
Plan to share: No
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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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alpha 1-Antitrypsin Deficiency →
Inhibrx Biosciences, Inc