A Trial to Evaluate the Safety Tolerability and Pharmacokinetics of B1344 by Subcutaneous Injection in Healthy Subjects

NCT05655221 | Unknown Phase 1 FDA Drug

• 1 other identifier: TSL-B1344-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety, tolerability, and immunogenicity of B1344 by single subcutaneous (s.c.) injection in healthy subjects

Conditions

Nonalcoholic Steatohepatitis

Keywords

Nonalcoholic Steatohepatitis; Phase I; B1344

Outcome Measures

Primary Outcomes (5)

• 12-lead electrocardiogram (ECG)

  Changes of 12-lead ECG from baseline

  From the screening period to 29 days after administration

• Renal Ultrasonography

  The examination of both kidneys using medical ultrasonography will be performed to detect any harmful abscesses, fluid collection, and infection within or around the kidneys.

  From the screening period to 29 days after administration

• Physical examinations

  Number of participants with abnormal Physical examinations.

  From the screening period to 90 days after administration

• Injection site reactions assessments

  The injection site reaction assessment will be done by the PI/investigational staff and study subject using the criteria, which consist of rating the severity of redness, swelling, skin temperature, sensitivity and pain at the injection site.

  Within 3 days of administration

• Anti-Drug Antibody(ADA)

  he incidence and proportion of ADA positive subjects.

  Within 29 days of administration

Study Arms (7)

Cohort 1

PLACEBO COMPARATOR

B1344/Placebo:2mg.

Drug: B1344; Other: Placebo

Cohort 2

PLACEBO COMPARATOR

B1344/Placebo:5mg.

Drug: B1344; Other: Placebo

Cohort 3

PLACEBO COMPARATOR

B1344/Placebo:15mg.

Drug: B1344; Other: Placebo

Cohort 4

PLACEBO COMPARATOR

B1344/Placebo:30mg.

Drug: B1344; Other: Placebo

Cohort 5

PLACEBO COMPARATOR

B1344/Placebo:45mg.

Drug: B1344; Other: Placebo

Cohort 6

PLACEBO COMPARATOR

B1344/Placebo:60mg.

Drug: B1344; Other: Placebo

Cohort 7

PLACEBO COMPARATOR

B1344/Placebo:80mg.

Drug: B1344; Other: Placebo

Interventions

B1344 DRUG

multi-site abdominal s.c. injections (maximum 2 mL at each site)

Also known as: pegylated conjugate of recombinant human mutated fibroblast growth factor 21

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7

Placebo OTHER

multi-site abdominal s.c. injections (maximum 2 mL at each site)

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing to participate in the study and sign informed consent form (ICF);
• Aged 18 to 55 years (inclusive) at the screening visit, male or female;
• Body weight ≥ 50 kg and body mass index (BMI) within the range of 18.5 to 29.9 kg/m2 (inclusive);
• Be in good health in the investigator's judgment, with no clinical significance in previous medical history, laboratory tests, physical examinations, vital signs, and ECG findings obtained at the screening visit and D-1;
• Female subjects:
• be of non-childbearing potential, including subjects surgically sterilized since at least 6 weeks before the screening visit (documented bilateral tubal ligation, bilateral salpingectomy, hysterectomy or bilateral oophorectomy), and post-menopausal for more than 12 continuous months of amenorrhea prior to the screening visit (menopause will be confirmed by a follicle stimulating hormone (FSH) level ≥ 40IU/L), or
• if having childbearing potential, must be non-pregnant, non-lactating, and must agree to use highly effective contraception with 2 forms of birth control (1 of which is a highly effective method and 1 must be a barrier method) from 30 days prior to dosing of the investigational medicinal product, for the duration of the study, and 3 months after the investigational medicinal product administration,
• must have a negative serum human chorionic gonadotropin (hCG) test for pregnancy confirmation at both the screening visit and D-1;
• Male subjects with female partners of childbearing potential must agree to use adequate contraception from 14 days prior to dosing of the investigational medicinal product, for the duration of the study, and 3 months after the investigational medicinal product administration. Male subjects must refrain from donating sperm during the same period.
• Understanding and be willing to comply with the study process and requirements.

You may not qualify if:

• Allergic to the investigational medicinal product or its excipients, or having a history of severe allergies (including any food allergy or drug allergy);
• Any disorder of the central nervous system, respiratory system, cardiovascular system, digestive system, hematological system, endocrine system, musculoskeletal diseases, urinary system, or any other disease or physical condition that may affect the study or pose an unacceptable risk to the subject in the investigator's judgment;
• Subjects infected with syphilis confirmed by Treponema pallidum test;
• Subjects with a history of hepatitis, or positive result at screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), hepatitis C virus (HCV RNA or HCV antibody), or human immunodeficiency virus antibody (anti-HIV);
• Confirmed (one set of consecutive triplicate measurements) average resting systolic blood pressure (SBP) \> 140 or \< 90 mmHg, and diastolic blood pressure (DBP) \> 90 or \< 45 mmHg at the screening visit or D-1; Repeat measurements are allowed at both screening and D-1；
• Confirmed (one set of consecutive triplicate measurements) average resting pulse rate \> 90 or \< 45 beats per minute (bpm) at the screening visit or D-1; Repeat measurements are allowed at both screening and D-1；
• Subjects with family history of long QT syndrome;
• Confirmed (the average of three consecutive interpretable 12-lead ECGs within 2-5 minutes) clinically significant abnormal supine 12-lead ECG, demonstrating a average QTCF(using Fridericia's formula, QTCF = QT/RR1/3) interval \> 450 msec for males or \> 470 msec for females, or a average QRS interval \>120 msec at the screening visit or D-1; Repeat measurements are allowed at both screening and D-1;
• Subjects with serum circulating alanine aminotransferase (ALT) or aspartate transaminase (AST), or total and indirect bilirubin \>1.25 x the upper limit of normal (ULN) at the screening visit or D-1; Repeat measurements are allowed at both screening and D-1；
• Subjects with serum creatinine \> ULN at the screening visit or D-1; Repeat measurements are allowed at both screening and D-1；
• Subject has a clinically significant history or evidence of gastrointestinal disorder(s), including reflux esophagitis, chronic diarrhea, gastritis, and inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis);
• Subjects with bone disease, including (but not limited to) osteoporosis (T-score ≤ -2.5); prior fractures, or clinically significant bone trauma, bone surgery, Addison's disease, osteomalacia, Paget's disease, and vitamin D deficiency(vitamin D ≤20 ng/mL).
• Subjects with a history of hypokalemia.
• Subjects who have been treated with any of the following:
• Subjects who have received oral bisphosphonates (\> 3 months cumulatively in the past 2 years or \> 1 month in the past year, or any use during the 3-month period prior to screening.

Sponsors & Collaborators

• Tasly Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

California Clinical Trials Medical Group, Inc.

Glendale, California, 91206, United States

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Kongli Zhu, MD

  Tasly Biopharmaceuticals Co., Ltd.

  STUDY CHAIR

Central Study Contacts

David Han, MD

CONTACT

800-239-4367; david.han@cctrials.com

Study Design

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

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: December 19, 2022
• Study Start: August 30, 2022
• Primary Completion: July 31, 2023
• Study Completion: January 30, 2024
• Last Updated: December 19, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)