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

Healthy Male Volunteers Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03863587
• Other study ID #: HLX12-001
• Status: Terminated
• Phase: Phase 1
• Start date: June 6, 2019
• Est. completion date: September 24, 2019

Study information

• Verified date: April 2022
• Source: Shanghai Henlius Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: September 24, 2019
• Est. primary completion date: September 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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;

Related Conditions & MeSH terms

• Healthy Male Volunteers

Intervention

Biological:
• HLX12
healthy volunters receive HLX12 (8mg/kg) once
• Cyramza (Ramucirumab)
healthy volunters receive Cyramza (Ramucirumab) 8mg/kg once

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Henlius Biotech

Country where clinical trial is conducted

China, 

References & Publications (1)

American Society for Clinical Pharmacology and Therapeutics. Clin Pharmacol Ther. 2022 Mar;111 Suppl 1:S5-S80. doi: 10.1002/cpt.2521. Erratum in: Clin Pharmacol Ther. 2022 Apr 17;:. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0~inf	Area under curve from zero to infinity	from predose to 1680 hours (Day 71),18 timepoints
Secondary	safety and tolerability of two groups	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	from day1 to day 71
Secondary	safety and tolerability of two groups	Number of AE as assessed by CTCAE v5.0	from day1 to day 71
Secondary	safety and tolerability of two groups	AE listing as assessed by CTCAE v5.0	from day1 to day 71
Secondary	AUC0~t	area under the concentration-time curve	from predose to 1680 hours (Day 71),18 timepoints
Secondary	Cmax	maximum concentration	from predose to 1680 hours (Day 71),18 timepoints