ACTRN12624000352505招募中1 期
A Phase 1, Placebo-Controlled, Single/Multiple Ascending Dose Study of DNTH103 Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Intravenous and Subcutaneous Administration in Healthy Volunteers.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Adult males and females, 18 to 65 years of age (inclusive) at Screening.
- •2. Body mass index less than or equal to 32 kg/m2, with a body weight (to 1 decimal place) greater than or equal to 45 kg and less than or equal to 100 kg at Screening.
- •3. Be non-smokers (including tobacco, e-cigarettes and marijuana) for at least 3 months prior to first study drug administration and have a negative test for cotinine at the Screening visit and at check-in on Day -1.
- •Note: Subjects who smoke no more than 2 cigarettes or equivalent per week may be included in the study but must be willing to abstain from smoking 7 days prior to admission and during the confinement period. Subjects must have a negative test for nicotine prior to check-in on Day -1.
- •4. Medically healthy without clinically significant abnormalities (in the opinion of the Investigator) at the Screening visit and after check-in on Day -1, prior to dose administration on Day 1, including:
- •a. Physical examination without any clinically significant findings.
- •b. Systolic blood pressure in the range of 90 to 150 mmHg (inclusive) and diastolic blood pressure in the range of 50 to 90 mmHg (inclusive) after 5 minutes rest in a semi-supine position.
- •c. Heart rate (HR) in the range of 40 to 90 bpm (inclusive) after 5 minutes rest in a semi- supine position.
- •d. Body temperature (tympanic) in the range 35.5°C to 37.7°C (inclusive).
- •e. No clinically significant findings in serum chemistry, haematology, coagulation and urinalysis tests as per PI.
- •f. Triplicate 12-lead ECG performed with no clinically significant abnormalities.
- •5. Female volunteers must:
- •a. Be of nonchildbearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before Screening) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause, and a follicle-stimulating hormone (FSH)level >40 IU/L at the Screening visit), or
- •b. If of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use an acceptable method of contraception from signing the consent form until at least 90 days after the last dose of the study drug.
- •6. Male volunteers must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception from signing the consent form until at least 90 days after the last dose of study drug.
- •7. Previously immunized against encapsulated bacterial pathogens as per country-specific guidelines (Neisseria meningitis, Haemophilus influenza, and Streptococcus pneumonia within past 5 years) or willing and able to be vaccinated during the Screening Period and at least 14 days prior to study drug administration on Day 1.
- •8. Haematocrit (HCT) and /Haemoglobin (Hb) levels within normal limits for age and sex at Screening and on Day -1, prior to dose administration.
排除标准
- •1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within 3 months prior to screening determined by the PI to be clinically significant.
- •2. History of autoimmune disease or positive autoantibody test result at Screening.
- •3. History of active malignancy within 5 years prior to Screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone.
- •4. Liver test results during Screening or at check-in day (Day 1) that are elevated more than 1.5-fold above the ULN for gamma glutamyl transferase, bilirubin (total), aspartate aminotransferase (AST) or alanine aminotransferase (ALT), unless a diagnosis of Gilbert syndrome. For history of Gilbert syndrome, the limit is extended to 2-fold above the ULN.
- •The above assessment may be repeated once, if abnormal values were recorded in the first instance, at the discretion of the PI.
- •5. Positive test results for human immunodeficiency virus (HIV-1 or HIV-2) antibody/antigen, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the Screening visit. Healthy volunteers who have no evidence of cirrhosis, have completed a curative intent regimen for HCV, and deemed by a gastroenterologist to have no active HCV will not be excluded.
- •6. Estimated creatinine clearance (CrCl) < 60 mL/min during Screening or at check-in day (Day -1) using the Cockcroft-Gault formula or serum creatinine more than 1.5-fold above the ULN.
- •7. History of substance abuse or alcohol abuse (defined as more than 10 standard drinks per week or regularly consuming more than 4 standard drinks on any one day; within 12 weeks prior to the Screening visit.
- •8. Positive drugs of abuse or alcohol breath test results at the Screening visit or at check-in (Day -1).
- •9. Use of any prescription or over-the-counter medication (including herbal products, vitamins, health supplements, diet aids, and hormone supplements) within 2 weeks or 5 half-lives of the medication(whichever is longer) prior to the first study drug administration, except use of contraceptives, occasional use of paracetamol (doses of 500 mg up to every 6 hours or 2 g per day maximum for no more than 3consecutive days) or where in the opinion of the Investigator, particular use would not interfere with the volunteer’s ability to participate in the trial.
- •10. Demonstrated clinically significant (required intervention, e.g., emergency room visit, epinephrine administration) allergic reactions (e.g., food, drug, or atopic reactions, asthmatic episodes) which, in the opinion of the Investigator, would interfere with the volunteer’s ability to participate in the trial.
- •11. Administration of any live, attenuated vaccines within 30 days and all other vaccinations within 14 days prior to study drug administration.
- •12. For women of childbearing potential (WOCBP), a positive serum pregnancy test at the Screening visit or a positive urine pregnancy test (with confirmatory serum pregnancy test) at check-in (Day -1).
- •13. Females who are breastfeeding or planning to breast feed at any time during the study.
- •14. Donation of blood or plasma within 30 days prior to first study drug administration, or loss of whole blood of
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