Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of ASC42 in Healthy Subjects

NCT04679129 | Completed Phase 1 FDA Drug

• 1 other identifier: ASC42-I-CTP-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This is a first in human study of single and multiple ascending doses and food effect of ASC42. This study consists of 8 cohorts and is divided as follows: Part Ia: Single ascending doses study including cohorts 1 to 5. Part Ib: A cross-over design of cohort 2 to study the food effect on ASC42 PK. Part II: Multiple ascending doses study including cohorts 6 to 8.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation and/or dose reductions, and AE of special interest, from baseline up to 21 days

  Up to 21 days

Secondary Outcomes (8)

• AUC of ASC42

  On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.

• Cmax of ASC42

  On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.

• t1/2 of ASC42

  On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.

• CL/F of ASC42

  On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.

• Vd/F of ASC42

  On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.

Study Arms (4)

Single Ascending Dose-ASC42

EXPERIMENTAL

ASC42 tablet，Dose 1，Dose 2，Dose 3，Dose 4，and Dose 5, single dose administration

Drug: ASC42

Multiple Ascending Dose-ASC42

EXPERIMENTAL

ASC42 tablet, Dose 1，Dose 2，Dose 3，q.d.×14 days

Drug: ASC42

Single Ascending Dose-Placebo

PLACEBO COMPARATOR

Placebo tablet，Dose 1，Dose 2，Dose 3，Dose 4，and Dose 5, single dose administration

Drug: Placebo

Multiple Ascending Dose-Placebo

PLACEBO COMPARATOR

Placebo tablet，Dose 1，Dose 2，Dose 3，q.d.×14 days

Drug: Placebo

Interventions

ASC42 DRUG

Oral tablets

Multiple Ascending Dose-ASC42; Single Ascending Dose-ASC42

Placebo DRUG

Oral tablets

Multiple Ascending Dose-Placebo; Single Ascending Dose-Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female subjects between 18 to 65 years of age.
• Subjects' weight ≥ 50 kg and BMI within the range of 19 - 29 kg/m2.
• Physical examination and vital signs are within normal range or slightly abnormal.

You may not qualify if:

• History or current liver disease, or liver injuries.
• A positive HBsAg, HCV Ab and/or HIV Ab.
• Platelet count \<150,000/mcL
• INR\> 1.2

Sponsors & Collaborators

• Gannex Pharma Co., Ltd.: lead

Study Sites (1)

ICON early Phase Services LLC

San Antonio, Texas, 78209, United States

Location

Related Publications (1)

• He H, Wu JJ. Human Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC42, a Novel Farnesoid X Receptor Agonist. Drugs R D. 2023 Dec;23(4):453-464. doi: 10.1007/s40268-023-00444-4. Epub 2023 Nov 2.

  PMID: 37919483 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 22, 2020
• Study Start: November 30, 2020
• Primary Completion: May 3, 2021
• Study Completion: June 3, 2021
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

US (1)