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

• ClinicalTrials.gov Identifier: NCT03863587
• Recruitment Status: Unknown
• First Posted: March 5, 2019
• Last Update Posted: January 2, 2020
• Sponsor: Shanghai Henlius Biotech
• Information provided by (Responsible Party): Shanghai Henlius Biotech

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy Male Volunteers	Biological: HLX12; Biological: Cyramza (Ramucirumab)	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 152 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: June 6, 2019
• Estimated Primary Completion Date: July 2020
• Estimated Study Completion Date: July 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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).	Biological: HLX12; healthy volunters receive HLX12 (8mg/kg) once
Active Comparator: 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).	Biological: Cyramza (Ramucirumab); healthy volunters receive Cyramza (Ramucirumab) 8mg/kg once

Outcome Measures

Primary Outcome Measures :

1. AUC0~inf [ Time Frame: from predose to 1680 hours (Day 71),18 timepoints ]
   Area under curve from zero to infinity

Secondary Outcome Measures :

1. safety and tolerability of two groups [ Time Frame: from day1 to day 71 ]
   Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
2. safety and tolerability of two groups [ Time Frame: from day1 to day 71 ]
   Number of AE as assessed by CTCAE v5.0
3. safety and tolerability of two groups [ Time Frame: from day1 to day 71 ]
   AE listing as assessed by CTCAE v5.0
4. AUC0~t [ Time Frame: from predose to 1680 hours (Day 71),18 timepoints ]
   area under the concentration-time curve
5. Cmax [ Time Frame: from predose to 1680 hours (Day 71),18 timepoints ]
   maximum concentration

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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;

Contacts and Locations

Contacts

Contact: Qi Jin, bachelor; +8615955160489; qi_jin@henlius.com

Contact: Jing Li; +8613816730978; Jing_Li@henlius.com

Locations

China, Jilin

First Hospital of Jilin University; Recruiting

Changchun, Jilin, China

Contact: Yanhua Ding 8618186879768

Sponsors and Collaborators

Shanghai Henlius Biotech

Investigators

• Principal Investigator: Yanhua Ding; First Hospital of Jinlin University

More Information

• Responsible Party: Shanghai Henlius Biotech
• ClinicalTrials.gov Identifier: NCT03863587
• Other Study ID Numbers: HLX12-001
• First Posted: March 5, 2019
• Last Update Posted: January 2, 2020
• Last Verified: December 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Ramucirumab; Antineoplastic Agents