CTRI/2025/08/092337已完成1 期
A single-dose, randomized, open-label, parallel-group, comparative pharmacokinetic and safety study of subcutaneously administered abatacept biosimilar DRL_AB via autoinjector or pre-filled syringe in normal healthy male participants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters: AUC0-t, Cmax, and AUC0-infinity
研究概览
简要总结
This is a Phase 1 comparative study conducted by Dr. Reddy’s Laboratories Ltd in male volunteers with DRL_AB Auto-injector and Pre-filled Syringe.
Dr.Reddy’s Abatacept (company product code: DRL_AB) is being developed as a biosimilar to the US licensed Reference Abatacept (Orencia®) and EU approved Reference (Orencia®). This study is part of global development program.
Normal healthy volunteers (NHV) are the population of choice (unless precluded for safety reasons) to establish PK similarity. The current study will be performed only in male subjects to avert gender-related variability. The 125 mg SC single dose is known to be safe for administration to NHV as it has been tested with appropriate safety and tolerability in prior studies
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •Healthy male volunteers aged 18 to 50 years, both inclusive, at the time of signing informed consent form.
- •Ability and amenability to provide written informed consent to participate in the study and adhere to study requirements.
- •Body mass index in the range 18.5 to 30.0 kg per square meter both inclusive and body weight of 60.0 to 100.0 kg, both inclusive.
- •General good health as determined by a qualified physician based on a comprehensive medical history, physical examination, vital signs, clinical laboratory tests like hematology, biochemistry, and urinalysis, and 12 lead electrocardiogram during screening.
- •Vital signs, physical examination, clinical laboratory tests, and 12 lead ECG results within normal range, or if outside the normal range, then assessed as clinically non significant by the investigator.
- •Willingness to use or with female partners willing to use at least one highly effective method of contraception as described below upto at least 3 months from the time of study intervention administration.
- •Note, Highly effective birth control measures per Clinical Trials Facilitation and Coordination Group guidelines 2024 include the following For a male participant a.
- •Permanently sterile by bilateral orchidectomy b.
- •Vasectomy c.
- •Maintaining sexual abstinence.
- •For the female partner of a male participant a.
- •Combined hormonal contraception associated with inhibition of ovulation oral, intravaginal, injectable, and transdermal b.
- •Progestogen only hormonal contraception associated with inhibition of ovulation oral, injectable, and implantable c.
- •Intrauterine device d.
- •Intrauterine hormone releasing system e.
- •Bilateral tubal occlusion Sexual abstinence defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments.
- •Note The reliability of sexual abstinence needs to be evaluated as per investigator’s judgement in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant.
- •It should be considered as true abstinence only, and not periodic abstinence.
- •Willingness to abide by study restrictions for the entire study duration.
排除标准
- •1.Positive or 2 successive indeterminate test results for Quantiferon TB Gold test.
- •Positive results for syphilis, hepatitis B like HBsAg, HBsAb, HBcAb, hepatitis C, or human immunodeficiency virus 1 or
- •Any prior exposure to abatacept or any other agent directly acting on CTLA4 or the CD28 CD80 co stimulation pathway including investigational products.
- •Vaccination with live vaccines within 3 months prior to screening or intention to receive live vaccines during the trial or up to 3 months after the administration of the study intervention.
- •Participants who have been administered non live vaccines at least more than a week prior to study intervention administration may be included.
- •History of immunodeficiency or other clinically significant immunological disorders, autoimmune disorders, or ongoing or frequent per recurring infections defined as more than 3 infections per year requiring treatment, participants with prior herpes zoster infection not fully healed, including the post herpetic neuralgia period if present within one year prior to randomization, or participants with history of systemic fungal infection within the 6 months prior to screening.
- •Allergy or hypersensitivity to any recombinant human or humanized antibodies, other therapeutic proteins or any excipients like dibasic sodium phosphate anhydrous, monobasic sodium phosphate monohydrate, L histidine, sodium chloride, poloxamer and sucrose of the study interventions.
- •History and or current manifestations of clinically significant, in the opinion of the investigator, atopic allergy, e.g., asthma including childhood asthma currently showing clinical manifestations, urticaria, angioedema, eczematous dermatitis, hypersensitivity, or allergic reactions or any history or presence of vasculitis or psoriasis.
- •Skin not suitable for dosing or post dosing evaluations on the upper arm for any reasons including presence of tattoos, skin pigmentation disorders, scarring etc., which may obscure the injection site.
- •Participation in blood donation or in any study requiring repeated blood sampling, hemorrhage requiring treatment, any transfusion in the past 3 months, or plasma donation within the 14 days prior to screening.
- •Systolic blood pressure more than 140 mm Hg or diastolic blood pressure more than 90 mm Hg when measured in the sitting position after 5 minutes rest, or current use of antihypertensive drugs.
- •Participants may be enrolled if blood pressure measurement is repeated up to 2 times on same or different days and if the mean of the measurements is within the above limits.
- •History of relevant orthostatic hypotension, fainting spells, or blackouts as well as history of difficulties with blood sampling that may potentially interfere with the study objectives and be deemed in the opinion of the investigator to pose clinical risk to the participants.
- •QTc Fridericia correction longer than 450 milliseconds or other clinically relevant ECG abnormalities such as atrial fibrillation, atrial flutter, Wolf Parkinson White syndrome, or presence of a cardiac pacemaker as found relevant clinically by the investigator.
- •History or presence of any clinically relevant nervous system disease including, but not restricted to stroke, transient ischemic attack, or seizures other than febrile seizures before the age of 5 years.
- •History of and or current gastrointestinal, renal, endocrine, pulmonary, hepatic, cardiovascular, including history of or presence of angina, exertional dyspnea, orthopnea, congestive heart failure or myocardial infarction and thrombotic or embolic episode requiring treatment, hematological including pancytopenia, aplastic anemia or blood dyscrasia and coagulopathies, or an international normalized ratio more than 1.5, or metabolic disorders including known diabetes mellitus considered significant by the investigator.
- •This criterion includes any disorder or condition that in the investigator’s opinion may interfere with the safety of the participant, the study evaluations, or the participant’s compliance to the study procedures and limitations.
- •Impaired hepatic function alanine transaminase or aspartate transaminase level more than 1.5× times upper limit of normal and or serum bilirubin 1.5× ULN at screening.
- •A single repeat test on a different day is allowed.
- •Participants with documented evidence of presence of Gilbert’s disease may be included if total bilirubin is 80 percent of the total bilirubin as per laboratory test.
- •Presence of any active infection assessed by the investigator even if minor and ongoing at the time of screening or on check in day or presence of any non healed wound or bone fracture of a clinically relevant size in the investigator’s opinion.
- •Participation in an interventional or phase 1 study in the last 3 months before enrollment, participation in more than 3 studies on experimental drug products in the past 12 months, intake of an investigational drug in a clinical trial setting within 3 months or 5 half lives, whichever is longer prior to intake of study drug in this trial, planned intake of an investigational drug with follow up visit scheduled during the course of this trial, or intake for any reason in the last 6 months of some specific long body residence drugs such as any immunoglobulin or antibody.
- •History of any cancer, including carcinoma in situ, lymphoma, or leukemia.
- •Major surgery within the past 6 months or any surgery including dental interventions within 3 months before study enrollment.
- •Intake of any medication including herbal products, vaccines, or immunomodulators within 3 weeks prior to study intervention administration other than nonsteroidal anti inflammatory drugs.
- •If any other drugs have been used, there should not be any evidence of potential drug drug interaction with abatacept.
- •Current smokers or those who have given up smoking including use of alternative tobacco products such as chewing tobacco and vaping less than 3 months prior to screening, or participants with positive urine cotinine test at screening or check in.
- •Positive alcohol breath test or positive urine test for drugs of abuse including benzodiazepines, amphetamines, barbiturates, cocaine, methadone, phencyclidine, 3,4 methylenedioxymethamphetamine, tetrahydrocannabinol, and opiates, at screening or at check in.
结局指标
主要结局
Pharmacokinetic parameters: AUC0-t, Cmax, and AUC0-infinity
时间窗: Pre-dose, 1.00h, 4.00h, 12.00h, 24.00h, 36.00h (Day 2), 48.00h (Day 3), 60.00h (Day 3), 72.00h (Day 4), 84.00h (Day 4), 96.00h (day 5), 108h (Day 5), 120h (Day 6), 132h (Day 6), 144h (Day 7), 156h (Day 7), 168h (Day 8), 216h (Day 10), 336h (Day 15), 504h (Day 22), 672h (Day 29), 840h (Day 36), 1008h (Day 43), 1176h (Day 50), 1344h (Day 57), 1680h (Day 71), and 2016h (Day 85)
次要结局
- • Pharmacokinetic parameters: Tmax, lambda z, t1/2, Vz/f, CL/f, and percent AUCextrap(• Safety: Incidence of AEs, SAEs, and AESIs)
研究者
Dr Siddangouda Patil
Syngene International Limited
研究点 (1)
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