CTRI/2022/02/039885尚未招募1 期
Phase-I, Open Label, Dose Escalation Study to Evaluate Safety, Tolerability andPharmacokinetics of AB1001 Topical Gel in Healthy Adult Male Volunteers
AHAMMUNE BIOSCIENCES PRIVATE LIMITED0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male subjects, aged >=18 years and <= 45 years, with a confirmed healthy
- •status as per standard screening procedure for healthy volunteers at the
- •screening center.
- •2. Subject is in good general health and free of any known uncontrolled
- •disease state or physical condition which, in the opinion of the investigator,
- •would interfere with the study assessments or put the subject at undue risk
- •by study participation.
- •3. Subjects must be willing and able to comply with the conditions specified in
- •this protocol and study procedures in the opinion of the Investigator.
- •4. Subjects must provide audio-visual and written informed consent prior to
- •any study-specific procedure.
- •5. Should have reliable access to the clinical trial center and available in the
- •area for at least one month.
排除标准
- •1. Hemoglobin, white blood cell (WBC), platelets, alanine transaminase
- •(ALT), and creatinine (Cr) outside of local lab normal range (subjects
- •may be included at the investigatorâ??s discretion for not clinically
- •significant values outside of normal range).
- •2. Subjects with a clinically significant abnormal thyroid-stimulating
- •hormone (TSH) or free T4 at screening.
- •3. Abnormal urinalysis as defined by positive urine glucose, protein, and
- •hemoglobin. Subject can be included if investigator determine the
- •abnormality is not clinically significant.
- •4. Use of any Investigational vaccine within the last five years except for
- •Covid-19 vaccines.
- •5. Chronic systemic immunosuppressive medications
- •6. Recurrent receipt of blood products or immunoglobulins.
- •7. Clinically significant medical condition, physical examination findings,
- •other clinically significant abnormal laboratory results, or past medical
- •history that may have clinically significant implications for current
- •health status and participation in the study in the opinion of the
- •Investigator.
- •8. Any contraindication to repeated phlebotomy.
- •9. History of or known active cardiac disease.
- •10. Infection with HIV, hepatitis B, and/or hepatitis C.
- •11. Having active Tuberculosis.
- •12. Psychiatric condition that precludes compliance with the protocol.
- •13. Suspected or known current alcohol or drug abuse as per discretion of
- •14. Any other finding that, in the judgment of the Investigator, would
- •interfere with, or serve as a contraindication to, protocol adherence,
- •assessment of safety or reactogenicity, or a subject s ability to give
- •informed consent, or increase the risk of having an adverse outcome
- •from participating in the study.
- •15. Any skin disease or history of skin disease that may interfere with the
- •study evaluation that, in the opinion of the investigator, would interfere
- •with the study medication application or study assessments.
- •16. Subject who has a history of serious local infection (e.g., cellulitis,
- •abscess) or systemic infection, or history of treated infection (e.g.,
- •pneumonia, septicemia) within 3 months prior to the screening visit.
- •17. History of allergic disorders including skin allergies and atopic diseases
- •such as eczema, asthma and rhinoconjunctivitis.
- •18. Subjects on an antibiotic for a non-serious, acute local infection must
- •complete the course prior to enrollment into the study.
- •19. Sexually active man with a partner of child-bearing potential not using
- •barrier contraception during the trial and for a period of the study.
- •20. Participation in a clinical trial for an investigational agent within 30 days
- •or 5 half-lives of the investigational agent (whichever is longer) of
研究者
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