NCT01060722已完成1 期
A Phase I, Randomized, Double-Blinded, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of a Long Acting Human Growth Hormone (hGH) Product (MOD-4023), in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety and Tolerability (AE's, vital signs, ECG, laboratory tests, local reaction)
研究概览
简要总结
This study aims to examine the safety, tolerability and pharmacokinetics of a long-lasting Human Growth Hormone (MOD-4023) in healthy volunteers after a single subcutaneous injection at escalating doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers aged 18-45 (inclusive) years.
- •Body Mass Index (BMI) 19 to 30 kg/m2 (inclusive) and weighing at least 55 Kg.
- •Non-smoking (by declaration) for a period of at least 6 months prior to screening visit.
- •Subjects in generally good health in the opinion of the investigator as determined by medical history, vital signs and a physical examination.
- •Blood pressure and heart rate within normal limits (blood pressure: systolic 90-140mmHg; diastolic 50-90 mmHg, heart rate 40-100 beats per minute).
- •Electrocardiogram (ECG) with no clinically significant abnormalities recorded at screening visit (up to 21 days before dosing) and on dosing day (before drug administration): PR interval within 120 and 200 ms, QRS interval < 120 ms, and QTc interval ≤ 440 ms.
- •Negative HIV, hepatitis B or hepatitis C serology tests at screening
- •No clinically significant abnormalities in complete blood count (CBC), prothrombin time (PT, INR), activated partial thromboplastin time (aPTT), chemistry lab tests (liver and renal function) and urinalysis at screening.
- •No history of alcohol or drug abuse. Negative urine DoA in screening and on admission. Negative breath alcohol on admission.
- •Subjects must agree to use medically accepted form of contraception from dosing day to 12 weeks after drug administration.
- •Subjects must be able to understand the requirements of the study and must be willing to comply with the requirements of the study and to provide their written informed consent to participate in the study.
排除标准
- •History of significant neurological (including history of seizures or EEG abnormalities), renal, cardiovascular (including known structural cardiac abnormalities or hypertension), respiratory (asthma), endocrinological, gastrointestinal, hematopoietic disease, neoplasm, psychological (marked anxiety, tension or agitation) or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medication.
- •Diabetes.
- •Known allergy to any drug.
- •Adherence (for whatever reason) to an abnormal diet during the 4 weeks prior to the study, or subjects with recent significant change in body weight.
- •Use of any prescription or over-the-counter (OTC) medications, including vitamins and herbal or dietary supplements within 14 days prior to dosing. Paracetamol for symptomatic relief of pain is allowed until 24 hours prior to the study drug administration.
- •Subjects who have received any vaccines within 4 weeks prior to study drug administration.
- •Subjects who donated blood in the three months or received blood or plasma derivatives in the six months preceding study drug administration.
- •Participation in another clinical trial with drugs within 3 months prior to dosing (calculated from the previous study's last dosing date).
- •Subjects with an inability to communicate well with the investigators and CRC staff (i.e., language problem, poor mental development or impaired cerebral function).
- •Subjects that have difficulty fasting or consuming the standard meals that will be provided.
- •Subjects with any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the Principal Investigator.
- •Subjects who are non-cooperative or unwilling to sign a consent form.
研究组 & 干预措施
MOD-4023, dose level 3
Experimental
干预措施: Placebo (Drug)
MOD-4023, dose level 1
Experimental
干预措施: MOD-4023 (long lasting hGH) (Drug)
MOD-4023, dose level 1
Experimental
干预措施: Placebo (Drug)
MOD-4023, dose level 2
Experimental
干预措施: MOD-4023 (long lasting hGH) (Drug)
MOD-4023, dose level 2
Experimental
干预措施: Placebo (Drug)
MOD-4023, dose level 3
Experimental
干预措施: MOD-4023 (long lasting hGH) (Drug)
结局指标
主要结局
Safety and Tolerability (AE's, vital signs, ECG, laboratory tests, local reaction)
时间窗: 30 days
Pharmacokinetics: AUC, Cmax, Tmax, T1/2
时间窗: 14 days
次要结局
- Formation of anti-drug antibodies(30 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety, Pharmacokinetics (PK) and Tolerability Study of a Novel Drug for Treatment of Bacterial InfectionsGram-negative Bacterial InfectionNCT01015014Pfizer64
已完成
1 期
Pharmacokinetics, Safety, and Tolerability of Intramuscular 5-MeO-DMT in Healthy VolunteersPharmacokineticsSafetyTolerabilityNCT05698095Usona Institute54
已完成
1 期
A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm InfantsRespiratory Syncytial VirusNCT02290340MedImmune LLC151
招募中
1 期
A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy SubjectsIgA NephropathyFocal Segmental GlomerulosclerosisNCT05942625Hansoh BioMedical R&D Company84
已完成
1 期
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy AdultsRespiratory Syncytial Virus InfectionsNCT02114268MedImmune LLC342