NCT04913090

Brief Summary

This study will consist of 3 parts: Part A - Single Ascending Dose (SAD) phase, Part B - multiple ascending dose (MAD) phase, and Part C - Food Effect (FE) phase.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

May 24, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

May 31, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2022

Completed
Last Updated

June 4, 2021

Status Verified

June 1, 2021

Enrollment Period

9 months

First QC Date

May 24, 2021

Last Update Submit

June 2, 2021

Conditions

Nonalcoholic Steatohepatitis (NASH)

Outcome Measures

Primary Outcomes (8)

  • Cmax

    Single dose：Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17，Food Effect:Day1-Day4,Day8-Day11

  • Tmax

    Single dose：Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17，Food Effect:Day1-Day4,Day8-Day11

  • AUClast

    Single dose：Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17，Food Effect:Day1-Day4,Day8-Day11

  • AUCinf

    Single dose：Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17，Food Effect:Day1-Day4,Day8-Day11

  • T1/2

    Single dose：Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17，Food Effect:Day1-Day4,Day8-Day11

  • CL/F

    Single dose：Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17，Food Effect:Day1-Day4,Day8-Day11

  • Vz/F

    Single dose：Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17，Food Effect:Day1-Day4,Day8-Day11

  • Subject incidence of adverse events for XZP-5610 versus placebo

    From drug administration to study completion. Single dose：15 days , Multi dose: 42 days，Food Effect: 11 days

Study Arms (6)

Part A-experimental

EXPERIMENTAL

Single Ascending Dose (SAD) phase

Drug: XZP-5610 Tablet (for Part A)

Part A-placebo

PLACEBO COMPARATOR

Single Ascending Dose (SAD) phase

Drug: Placebo to match XZP-5610 Tablet (for Part A)

Part B-experimental

EXPERIMENTAL

multiple ascending dose (MAD) phase

Drug: XZP-5610 Tablet (for Part B)

Part B-placebo

PLACEBO COMPARATOR

multiple ascending dose (MAD) phase

Drug: Placebo to match XZP-5610 Tablet (for Part B)

Part C1-experimental

EXPERIMENTAL

Food Effect (FE) phase

Drug: XZP-5610 Tablet （for "Part C1"）Drug: XZP-5610 Tablet for "Part C2"

Part C2-experimental

EXPERIMENTAL

Food Effect (FE) phase

Drug: XZP-5610 Tablet （for "Part C1"）Drug: XZP-5610 Tablet for "Part C2"

Interventions

XZP-5610 Tablet (for Part A)DRUG

Tablet(s) administered orally once daily for 1 Day

Also known as: 5610
Part A-experimental
Placebo to match XZP-5610 Tablet (for Part A)DRUG

Tablet(s) administered orally once daily for 1 Day

Also known as: 5610 Placebo
Part A-placebo
XZP-5610 Tablet (for Part B)DRUG

Tablet(s) administered orally once daily for 14 Days

Also known as: 5610
Part B-experimental
Placebo to match XZP-5610 Tablet (for Part B)DRUG

Tablet(s) administered orally once daily for 14 Days

Also known as: 5610 Placebo
Part B-placebo
XZP-5610 Tablet （for "Part C1"）DRUG

Tablet(s) administered fasted orally once daily for 1 Day

Also known as: 5610
Part C1-experimentalPart C2-experimental
XZP-5610 Tablet for "Part C2"DRUG

Tablet(s) administered after a high-fat meal orally once daily for 1 Day

Also known as: 5610
Part C1-experimentalPart C2-experimental

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult males or females aged 18 to 60 years (inclusive).
  • Body weight ≥ 50 kg for males and ≥ 45 kg for females; body mass index (BMI) in the range 19.0-28.0 kg/m2 for the non-obese group and in the range of 28.1 -35.0 kg/ 2 for the obese group (inclusive, BMI=weight/height2).
  • No plans to have children within the last 6 months, no plans to donate sperm/egg, and willing to use effective contraception within 6 months after the end of dosing
  • No clinically significant vital signs, physical examination, laboratory tests, or ECG or chest radiograph findings.
  • Subjects understand and comply with the study procedures, voluntarily participate, and sign an Informed Consent Form.

You may not qualify if:

  • History or presence of severe systemic diseases such as endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic epilepsy) abnormalities.
  • History of clinically significant ECG abnormalities or family history of long QT syndrome (grandparents, parents and siblings)
  • Part A:
  • Confirmation of QTcF ≥ 450 ms by repeated measurements;
  • Confirmation of QRS duration \> 120 ms by repeated measurements;
  • Confirmation of PR interval \> 200 ms by repeated measurements;
  • Findings that lead to difficulties in QTc measurement or difficult interpretation of QTc data;
  • History of other risk factors for Torsades de Pointes tachycardia (e.g., heart failure, hypokalemia, family history of long QT syndrome);
  • Presence of uncorrected hypokalemia or hypomagnesemia.
  • Parts B and C:
  • Family history of long QT syndrome (grandparents, parents and siblings);
  • Resting QTcF ≥ 450 ms (males) or ≥ 460 ms (females) during the screening or baseline period.
  • Subjects with a known or suspected history of allergy to the test drug or its adjuvant components, or a history of clinically significant severe allergy (e.g., food, drug, latex allergy), or a history of atopic allergic disease (asthma, urticaria, eczematous dermatitis)
  • History of dysphagia or any gastrointestinal disorder affecting drug absorption at screening, including history of frequent nausea or vomiting of any etiology, history of irregular gastrointestinal motility such as habitual diarrhea, constipation or bowel pre-excitation syndrome, or history of major gastrointestinal surgery (e.g., gastrectomy, gastrointestinal anastomosis, bowel resection, gastric bypass, gastric division, or gastric banding)
  • History of pancreatic injury or pancreatitis at screening, or significantly elevated blood amylase (\> 1.5 x ULN)
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

azelastine

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Dongyang Liu, Doctor

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Chen

CONTACT

+86-13910591245chenying@xuanzhubio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2021

First Posted

June 4, 2021

Study Start

May 31, 2021

Primary Completion

March 4, 2022

Study Completion

March 4, 2022

Last Updated

June 4, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)