PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis
NCT05022693 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2022-03-02
Summary
This is an open-label, single-dose study to evaluate the PK profile of the liquid SC formulation of BIO89-100 in approximately 8 male and female subjects with NASH with compensated cirrhosis.
Conditions
- NASH - Nonalcoholic Steatohepatitis
Interventions
- DRUG
-
BIO89-100
Subcutaneous Injections
Sponsors & Collaborators
-
89bio, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-08-16
- Primary Completion
- 2021-12-21
- Completion
- 2021-12-21
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study to Compare How the Study Medicine (PF-07923568) is Processed in Participants With Different Levels of Loss of Liver Function to Healthy Participants.
NCT05857644 ·Status: COMPLETED ·Phase: PHASE1
-
The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis
NCT04134091 ·Status: COMPLETED ·Phase: PHASE2
-
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
NCT05117489 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial
NCT04685993 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Experimental Medication BMS-986036 Given to Healthy Participants
NCT03445208 ·Status: COMPLETED ·Phase: PHASE1
-
Betaine in Patients With Nonalcoholic Steatohepatitis
NCT00586911 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of INI-822 in Healthy Volunteers and Participants with Non-alcoholic Steatohepatitis (NASH) or Presumed NASH
NCT05945537 ·Status: RECRUITING ·Phase: PHASE1
-
A Study to Test How Well BI 770371 is Tolerated by People With Cirrhosis Caused by a Liver Disease Called MASH
NCT06675929 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of LCZ696 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers
NCT01621633 ·Status: COMPLETED ·Phase: PHASE2
-
BREATHID Octanoate Breath Test With or Without Methacetin Breath Test for Correlation With Biopsy in NASH
NCT02314026 ·Status: COMPLETED ·Phase: PHASE2
-
A Research Study Looking at How a Single Dose of the Study Medicine NNC0194-0499 Behaves in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function
NCT05917938 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults With NASH
NCT05118360 ·Status: WITHDRAWN ·Phase: PHASE2
-
Safety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis
NCT02510599 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CS0159 in Subjects With NASH
NCT05591079 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 2b Study of GSK4532990 in Adults With NASH
NCT05583344 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Sub-study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
NCT03400163 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 1 Pharmacokinetic Study Of CP-945598 In Patients With NASH
NCT00706537 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 1 Study to Evaluate Safety of GR-MD-02 in Subjects With Non-Alcoholic Steatohepatitis (NASH) and Advanced Fibrosis
NCT01899859 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of HEC96719 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis
NCT05397379 ·Status: COMPLETED ·Phase: PHASE2
-
Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)
NCT04697810 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-3655-001)
NCT04583423 ·Status: TERMINATED ·Phase: PHASE2
-
Study of SGM-1019 in Patients With Nonalcoholic Steatohepatitis (NASH)
NCT03676231 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
NCT05809934 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate MET642 in Patients With NASH
NCT04773964 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Effect of Hepatic Impairment on JNJ-56136379
NCT04208399 ·Status: COMPLETED ·Phase: PHASE1