NCT04965337

Brief Summary

This is a Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Single Center Bridging Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in Chinese Healthy Subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jul 2021

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

July 11, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

21 days

First QC Date

July 7, 2021

Last Update Submit

June 28, 2022

Conditions

Healthy

Keywords

Healthy SubjectsASC42FXR agonist

Outcome Measures

Primary Outcomes (2)

  • AUC of ASC42

    Evaluate the Area under the plasma concentration versus time curve.

    Up to 4 days

  • Cmax of ASC42

    Evaluate the Peak Plasma Concentration.

    Up to 4 days

Secondary Outcomes (4)

  • t1/2 of ASC42

    Up to 4 days

  • CL/F of ASC42

    Up to 4 days

  • Vd/F of ASC42

    Up to 4 days

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

    Up to 7 days

Study Arms (4)

ASC42 Dose A

EXPERIMENTAL

ASC42 tablet Dose A, once daily

Drug: ASC42

Placebo Dose A

PLACEBO COMPARATOR

Placebo Comparator: Single dose of matched placebo to ASC42 tablet Dose A, once daily

Drug: Placebo

ASC42 Dose B

EXPERIMENTAL

ASC42 tablet Dose B, once daily

Drug: ASC42

Placebo Dose B

PLACEBO COMPARATOR

Placebo Comparator: Single dose of matched placebo to ASC42 tablet Dose A, once daily

Drug: Placebo

Interventions

ASC42DRUG

ASC42 tablet administered orally

ASC42 Dose AASC42 Dose B
PlaceboDRUG

Matching placebo administered orally

Placebo Dose APlacebo Dose B

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female volunteers aged 18-55 years.
  • kg/m2 ≤ BMI \<24kg/m2.

You may not qualify if:

  • A positive HBsAg, HCV Ab and/or HIV Ab.
  • Pancreatic injury or pancreatitis.
  • History of organ transplantation, including bone marrow transplantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Boai Rehabilitation Hospital

Changsha, Hunan, 410008, China

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2021

First Posted

July 16, 2021

Study Start

July 11, 2021

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

June 30, 2022

Record last verified: 2022-06

Locations

CN(1)