| Trial ID: | L0460 |
| Source ID: | NCT04048135
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| Associated Drug: |
BIO89-100
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| Title: |
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of BIO89-100 Administered Subcutaneously in Subjects With Nonalcoholic Steatohepatitis (NASH) or With Nonalco
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| Acronym: |
--
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| Status: |
Not recruiting
|
| Study Results: |
No Results Available
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| Results: |
--
|
| Conditions: |
NASH
|
| Interventions: |
Drug: BIO89-100;Other: Placebo
|
| Outcome Measures: |
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs);Number of subjects who discontinued due to AEs and due to related AEs;To characterize the BIO89-100 Pharmacokinetics (PK) by Peak Plasma Concentration;To characterize the BIO89-100 PK by Time to Peak Plasma Concentration (Tmax);To characterize the BIO89-100 PK by Area under the plasma concentration versus time curve (AUC);To characterize the BIO89-100 PK by the terminal elimination half-life (t1/2);To characterize effect of BIO89-100 on liver histology by Improvement in NAS scorePercentage change from baseline in Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF);Percentage change from baseline in triglycerides;Percentage change from baseline in Low Density Lipoprotein (LDL) Cholesterol;Percentage change from baseline in Alanine Transaminase (ALT);Percentage change from baseline in N-terminal type III collagen propeptide (Pro-C3);Assessment of the incidence and characteristics of anti drug antibodies (ADA) developed against BIO89-100 after dosing;To characterize effect of BIO89-100 on liver histology by improvement of fibrosis;To characterize effect of BIO89-100 on liver histology by NASH resolution
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| Sponsor/Collaborators: |
89bio, Inc.
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| Gender: |
All
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| Age: |
21 Years75 Years
|
| Phases: |
Phase 1/Phase 2
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| Enrollment: |
101
|
| Study Type: |
Interventional
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| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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| Start Date: |
04/08/2019
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
10 August 2021
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| Locations: |
United States;Puerto Rico;United States
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| URL: |
https://clinicaltrials.gov/show/NCT04048135
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