NCT03863587 is a Phase 1 clinical trial of HLX12 in Healthy Male Volunteers, sponsored by Shanghai Henlius Biotech.

Who is sponsoring NCT03863587?

NCT03863587 is sponsored by Shanghai Henlius Biotech.

What drugs are being tested in NCT03863587?

Interventions in NCT03863587: HLX12, Cyramza (Ramucirumab).

What condition does NCT03863587 study?

NCT03863587 studies Healthy Male Volunteers.

Is NCT03863587 still recruiting?

NCT03863587 is currently terminated. Last updated 10 May 2022.

Last reviewed 2022-05-10 · How we verify

NCT03863587

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 1 Last updated 10 May 2022

What this trial tests

Phase 1 trial testing HLX12 in Healthy Male Volunteers in 24 participants. Terminated before completion.

Timeline

6 June 2019

Primary endpoint
24 September 2019

24 September 2019

Quick facts

Lead sponsor	Shanghai Henlius Biotech
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	24
Start date	6 June 2019
Primary completion	24 September 2019
Estimated completion	24 September 2019
Sites	1 location across China

Drugs / interventions tested

HLX12 — full drug profile →
Cyramza (Ramucirumab) — full drug profile →

Conditions studied

Healthy Male Volunteers — all drugs for Healthy Male Volunteers →

Sponsor

Shanghai Henlius Biotech — full company profile →

Who can join

Adults 18 to 50, male only, with Healthy Male Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Healthy Male Volunteers

Currently open trials in the same condition.

NCT07479745 — Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]GRT6019 · Phase 1 · recruiting

Other Shanghai Henlius Biotech trials

Trials by the same sponsor.

NCT07518043 — A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors · Phase 1 · not yet recruiting
NCT07477587 — A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in · Phase 1 · not yet recruiting
NCT07533708 — A Phase I Clinical Study of HLX3902 in Patients With mCRPC and Other Advanced Tumours · Phase 1 · not yet recruiting
NCT07484893 — A Study to Evaluate the Safety, PK, and Immunogenicity of Recombinant Human Hyaluronidase in Healthy Subjects · Phase 1 · not yet recruiting
NCT07495930 — Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With EU-Phesgo® · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03863587 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shanghai Henlius Biotech
Last refreshed: 10 May 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03863587.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing