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Nonalcoholic SteatohepatitisPhase 1NCT05655221

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

A Phase 1 study testing B1344 in people with Nonalcoholic Steatohepatitis, run by Tasly Biopharmaceuticals Co., Ltd. at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Nonalcoholic Steatohepatitis
What is being tested?
B1344
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
1 siteUnited States
Study dates
30 Aug 2022to 30 Jan 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects must meet all of the following inclusion criteria for study entry:
  • 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:
Show all 52Show fewer
  • 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.
  • Exclusion criteria: Subjects who meet any of the following criteria will be excluded from study entry:
  • 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.
  • Intravenous bisphosphonate, fluoride, or strontium within 5 years.
  • Parathyroid hormone (PTH) or PTH derivatives (teriparatide, Abaloparatide) within the last year, or treatment with denosumab.
  • Subjects who have received the following within three months of screening:
  • Any selective estrogen receptor modulator (SERM)
  • Tibolone
  • Anabolic steroids or testosterone
  • Systemic hormonal replacement therapy
  • Calcitonin
  • Active vitamin D analogues
  • Other bone active drugs, including anti-convulsants (except benzodiazepines) and heparin
  • Glucocorticoids, chronic systemic ketoconazole, androgens, adrenocorticotropic hormone (ACTH), cinacalcet, aluminum, lithium protease inhibitors, gonadotropin-releasing hormone agonists
  • Calcineurin inhibitors.
  • History of drug abuse, or positive urine drug test (e.g., barbiturates, benzodiazepines, methadone, buprenorphine, amphetamines, methamphetamines, opiates, cocaine, cannabinoids) at the screening visit or D-1;
  • History of regular alcohol consumption within 6 months prior to screening, with more than 14 units of alcohol per week (or an average daily intake > 2 units for men, > 1 unit for women). One unit is equal to 5 ounces [150 mL] of wine (12% alcohol), or 12 ounces [360 mL] of regular beer (5% alcohol), or 1.5 ounces [45 mL] of 80 proof distilled spirits (40% alcohol); and/or positive alcohol test at the screening visit or D-1;
  • Smoking more than 5 cigarettes per day within 3 months prior to screening, or positive for nicotine test at the screening visit or D-1;
  • Consuming excessive amount > 6 servings of coffee, tea, cola, energy drink, or other caffeine-containing product per day. One serving ≈ 120 mg of caffeine. Or consumed any caffeine-containing product within 24 hours prior to dosing of the IMP;
  • Unable to refrain from using any medication, including prescription and non-prescription drugs, herbal remedies, dietary supplements within 14 days or 5 half-lives (whichever is longer) prior to dosing of the IMP and for the duration of study until the last visit.
  • Participated in any clinical trial and received an investigational medicine or medical device within 30 days prior to dosing of the investigational medicinal product. If the 5 half-lives of the investigational medicine are longer than 30 days, then 5 half-lives should be considered as the time limitation;
  • Currently pregnant or lactating, or intending to become pregnant during the study;
  • Had blood donation or blood loss over 500 mL within 3 months prior to screening;
  • Subject has clinical signs and symptoms consistent with COVID-19, e.g., fever, dry cough, dyspnea, sore throat, fatigue, or confirmed current infection by appropriate laboratory test or contact to any SARS-CoV-2 positive or COVID-19 patient within the last 4 weeks prior to investigational medicinal product administration. .
  • Subject who had severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated).
  • Subject scheduled to receive COVID-19 vaccination within 2 weeks before or after the investigational medicinal product administration.
  • Subject has received the second COVID-19 vaccination or booster less than 4 weeks (if on a single dose vaccination, it should be 4 weeks after) before the investigational medicinal product administration.
  • Other conditions considered to be ineligible for study entry in the PI's judgment.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

David Han, MD contact

800-239-4367

david.han@cctrials.com

United States1 site, 1 recruiting

  • California Clinical Trials Medical Group, Inc.

    Glendale, California, 91206

    David Han, MD, david.han@cctrials.com

    Recruiting

Other trials in United States

About this study

Official title: A First-in-human, Randomized, Double-blind, Parallel, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of B1344 by Subcutaneous Injection in Healthy Subjects

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

Being tested
B1344, Placebo
Keywords
Nonalcoholic Steatohepatitis, Phase I, B1344
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • B1344Drug

    Also called pegylated conjugate of recombinant human mutated fibroblast growth factor 21

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

  • PlaceboOther

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

Study groups in NCT05655221
Study groupRoleWhat they receive
Cohort 1Placebo comparatorB1344/Placebo:2mg.
Receives: Drug: B1344; Other: Placebo
Cohort 2Placebo comparatorB1344/Placebo:5mg.
Receives: Drug: B1344; Other: Placebo
Cohort 3Placebo comparatorB1344/Placebo:15mg.
Receives: Drug: B1344; Other: Placebo
Cohort 4Placebo comparatorB1344/Placebo:30mg.
Receives: Drug: B1344; Other: Placebo
Cohort 5Placebo comparatorB1344/Placebo:45mg.
Receives: Drug: B1344; Other: Placebo
Cohort 6Placebo comparatorB1344/Placebo:60mg.
Receives: Drug: B1344; Other: Placebo
Cohort 7Placebo comparatorB1344/Placebo:80mg.
Receives: Drug: B1344; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 12-lead electrocardiogram (ECG)

    Changes of 12-lead ECG from baseline

    Measured: From the screening period to 29 days after administration

  2. 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.

    Measured: From the screening period to 29 days after administration

  3. Physical examinations

    Number of participants with abnormal Physical examinations.

    Measured: From the screening period to 90 days after administration

  4. 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.

    Measured: Within 3 days of administration

  5. Anti-Drug Antibody(ADA)

    he incidence and proportion of ADA positive subjects.

    Measured: Within 29 days of administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2022
  2. Study start30 Aug 2022
  3. Primary completion31 Jul 2023 (estimated)
  4. Study completion30 Jan 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05655221
Sponsor's protocol ID
TSL-B1344-01
Status last verified
Dec 2022
First submitted
11 Nov 2022
Last updated
19 Dec 2022
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing B1344 in people with Nonalcoholic Steatohepatitis, run by Tasly Biopharmaceuticals Co., Ltd. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 52 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact David Han, MD (800-239-4367, david.han@cctrials.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

12-lead electrocardiogram (ECG) (time frame: From the screening period to 29 days after administration). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05655221.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2022.

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