This is Comparative Study in Normal Healthy Subjects to Evaluate Pharmacokinetics, Safety, Tolera… (NCT06738277) | Clinical Trial Compass
CompletedPhase 1
This is Comparative Study in Normal Healthy Subjects to Evaluate Pharmacokinetics, Safety, Tolerability of Bmab 1200 -Autoinjector (AI) After Single Subcutaneous Injection (45 mg) in Comparison With Bmab 1200 -Prefilled Syringe (PFS).
India186 participantsStarted 2025-01-09
Plain-language summary
This is an open-label, 2-arm parallel-group study in normal healthy subjects to evaluate pharmacokinetics, safety, tolerability of Bmab 1200 -autoinjector (AI) after single subcutaneous injection (45 mg) in comparison with Bmab 1200 -prefilled syringe (PFS).
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* a.Non-smokers, healthy, adult, human volunteers between 18 to 55 years of age (both inclusive).
b.Having BMI between 18.5 to 28.0 m2 and having a body weight between 60 kg and 90 kg (both inclusive for both parameters).
c.Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG and X-ray chest (P/A view) recordings.
d.Able to understand and comply with the study procedures, in the opinion of the investigator.
e.Able to give voluntary written informed consent for participation in the study.
f.Subjects should not receive a BCG vaccine within 1 year before dosing and agree to not take it during the study and at least 1 year after dosing.
g.Subjects will agree not to receive live vaccination during the study. h.Subject will agree not to donate blood/ plasma/ platelets during the study and at least 3 months after the end of study.
i.For male subjects i.Subjects agree to use effective contraception (e.g. Double barrier method) and refrain from donation of sperm from check-in until 90 days after the end of study.
j.In case of female subjects: i.Surgically sterilized at least 6 months prior to study participation Or If subject is of child-bearing potential, is willing to use a suitable and effective double barrier contraceptive method or intrauterine device during the study and till 4 months after the end of study.
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