Compare Pharmacokinetic, Safety, Tolerability and Immunogenicity of HLX12 and Ramucirumab in Healthy Male Adult Subjects

NCT ID: NCT03863587

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-06
• Study Completion Date: 2019-09-24

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.

Conditions

Healthy Male Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HLX12 group

HLX12 are given intravenous infusion 8 mg/kg, prepared with normal saline to an administration volume of 250 mL, and the administration time is 90 min (± 10 min).

Group Type: EXPERIMENTAL

HLX12

Intervention Type: BIOLOGICAL

healthy volunters receive HLX12 (8mg/kg) once

Cyramza (Ramucirumab) group

Ramucirumab are given intravenous infusion of Cyramza 8 mg/kg, prepared with normal saline to an administration volume of 250 mL, and the administration time is 90 min (± 10 min).

Group Type: ACTIVE_COMPARATOR

Cyramza (Ramucirumab)

Intervention Type: BIOLOGICAL

healthy volunters receive Cyramza (Ramucirumab) 8mg/kg once

Interventions

HLX12

healthy volunters receive HLX12 (8mg/kg) once

Intervention Type: BIOLOGICAL

Cyramza (Ramucirumab)

healthy volunters receive Cyramza (Ramucirumab) 8mg/kg once

Intervention Type: BIOLOGICAL

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Henlius Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanhua Ding

Role: PRINCIPAL_INVESTIGATOR

First Hospital of Jinlin University

Locations

First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 35132630 (View on PubMed)

Other Identifiers

HLX12-001

Identifier Type: -

Identifier Source: org_study_id