Clinical trial NCT03863587: Compare Pharmacokinetic, Safety, Tolerability and Immunogenicity of HLX12 and Ramucirumab in Healthy Male Adult Subjects
Official title: A Randomized, Parallel-controlled, Intravenous Single-dose, Phase I Clinical Study Comparing the Pharmacokinetic Profile, Safety, Tolerability and Immunogenicity of HLX12 and Cyramza (Ramucirumab) in Healthy Male Adult Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Male Volunteers
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2019-03-05
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study consists of 2 parts:

Part I study: to preliminarily compare the PK profile of HLX12 and Cyramza This study is an open-label, randomized, parallel-controlled, intravenous single-dose pretrial study comparing the pharmacokinetic profile, safety, tolerability and immunogenicity of HLX12 and Ramucirumab in healthy male adult subjects. The number of subjects is set to 24, who will be randomized into two groups, and each group has the same number of subjects (n=12). Group 1 will receive intravenous infusion of the test preparation T HLX12, while Group 2 will receive Cyramza, once in both groups.

Part II study: to compare the PK similarity between HLX12 and Cyramza This study is a randomized, double-blind, parallel-controlled, intravenous single-dose Phase I clinical study comparing the pharmacokinetic profile, safety, tolerability and immunogenicity of HLX12 and Ramucirumab in healthy male adult subjects.The number of subjects is set to 128, and the treatment is the same with Part I study.


Eligibility criteria: Inclusion Criteria:

Healthy adult male aged 18-50 years (including 18 and 50 years old) with a body mass index of 18-28 kg/m2 (including 18 kg/m2 and 28 kg/m2), weighing ≥50 kg and ≤80 kg;

Exclusion Criteria:

Previous or current atopic allergies, hypersensitivity reactions, or allergic reactions that are clinically significant, including known or suspected clinically relevant drug allergies to a component of the study drug or the control drug; Any disease that may affect the safety of the subject or affect the study operation and assessment, according to the investigator's judgment; Have undergone surgery in the past 8 weeks, or are planned for surgery during the study period; Have been inoculated with live virus vaccine within 4 weeks prior to screening, or intend to be inoculated with live virus vaccine during the study period until the end of the last follow-up; Any prior history of exposure to anti-VEGF or anti-VEGF receptor monoclonal antibodies/proteins; Exposure to any monoclonal antibody within 12 months prior to study drug administration; Have used any clinical study drug within 3 months prior to screening, or are still in the follow-up period of a clinical study; Have taken non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to the study drug administration, including any dose of aspirin. NSAIDs (except acetaminophen) shall not be used during the study; QTc interval \> 450 ms; ECG is abnormal and the abnormality is clinicaly significant as judged by the investigator; Have taken any alcoholic products within 48 hours prior to the study drug administration; Subjects who have a family history of hypertension, or are found with abnormal blood pressure at screening or on admission to the study site (Day-1): systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, which is judged by the investigator as clinically significant ; Have a genetic predisposition to bleeding or thrombosis, or a history of bleeding due to non-trauma (ie, bleeding requiring medical intervention), a thromboembolic event, or any condition that may increase the risk of bleeding, including coagulopathy, thrombocytopenia (platelet count \<100\*109/L) or international normalized ratio (INR) higher than 1.5;

Primary outcomes:
measure: AUC0~inf
timeFrame: from predose to 1680 hours (Day 71),18 timepoints
Secondary outcomes:
measure: safety and tolerability of two groups
timeFrame: from day1 to day 71
measure: safety and tolerability of two groups
timeFrame: from day1 to day 71
measure: safety and tolerability of two groups
timeFrame: from day1 to day 71
measure: AUC0~t
timeFrame: from predose to 1680 hours (Day 71),18 timepoints
measure: Cmax
timeFrame: from predose to 1680 hours (Day 71),18 timepoints
Other outcomes:
Locations:
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: First Hospital of Jinlin University
name: Yanhua Ding
role: PRINCIPAL_INVESTIGATOR
References:
citation: American Society for Clinical Pharmacology and Therapeutics. Clin Pharmacol Ther. 2022 Mar;111 Suppl 1:S5-S80. doi: 10.1002/cpt.2521. No abstract available.