Phase 1 Study to Assess the Safety, PK and PD of INBRX-101 in Adults With Alpha-1 Antitrypsin Deficiency

Conditions

• AATD
• Alpha-1 Antitrypsin Deficiency

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• INBRX-101/rhAAT-Fc — DRUG
  INBRX-101 is a recombinant human alpha-1 antitrypsin (AAT) Fc fusion protein (rhAAT-Fc).

Study Details

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.

Key Dates

First listed

Jan 24, 2019

Start date

Jul 19, 2019

Status verified

Sep 2022

Primary completion

Aug 18, 2022

Completion

Aug 18, 2022

Study Design

Enrollment

31 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1 Single Ascending Dose
  INBRX-101 will be escalated in subjects with alpha-1 antitrypsin deficiency (AATD).
• Experimental: Part 2 Multiple Ascending Dose
  INBRX-101 will be escalated in subjects with alpha-1 antitrypsin deficiency (AATD).

Primary Outcome Measure

Frequency of adverse events of INBRX-101 [ Time Frame: Up to 7 months ]

Locations (5)

Find similar trials in Sacramento, CA

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