Study on Food Influence and Drug-drug Interaction of HLX208 Tablets in Chinese Healthy Subjects

This study is divided into Part I and Part II. Part I is the food effect study. A total of 20 healthy subjects, regardless of gender, will be enrolled in a randomized, open-label, crossover design.

Part II is the drug-drug interaction study, an open-label and sequential design. 32 healthy subjects are planned to be enrolled and divided into group A and group B. Group A is to evaluate the influence of itraconazole as CYP3A4 strong inhibitory on HLX208. Group B was to evaluate the effect of rifampicin as a strong inducer of CYP3A4 on HLX208.

Study Overview

• Status: Completed
• Conditions: NSCLC
• Intervention / Treatment: Drug: HLX208; Drug: HLX208; Drug: HLX208; Drug: HLX208; Drug: Itraconazole 200 mg; Drug: Rifampicin

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China
      • The First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Sign the informed consent before the trial, and fully understand the content, process and possible adverse reactions of the trial. Must be able to communicate with the investigator, understand and comply with all study requirements;
2. Male or female subjects aged 18 to 45 (including 18 and 45);
3. Weigh at least 50 kg (for male) and 45 kg (for female), respectively, and have a body mass index (BMI) ≥ 19 and ≤26 kg/m2. BMI = weight (kg)/[height (m)]2;

Exclusion Criteria:

1. Known history of drug or food allergy;
2. Those who have a positive urine drug screen or have a history of drug abuse;
3. Excessive smoking (≥ 5 cigarettes/day);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HLX208 in the fast state; HLX208 900mg in the fast state	Drug: HLX208; Subjects will receive treatment HLX208 900 mg in the fast state followed by 7 days washout ，then receive treatment HLX208 900 mg in the fed state; Drug: HLX208; Subjects will receive treatment HLX208 900 mg in the fed state followed by 7 days washout ，then receive treatment HLX208 900 mg in the fast state.; Drug: HLX208; 450 mg; Drug: HLX208; 900 mg
Experimental: HLX208 in the fed state; HLX208 900mg in the fed state	Drug: HLX208; Subjects will receive treatment HLX208 900 mg in the fast state followed by 7 days washout ，then receive treatment HLX208 900 mg in the fed state; Drug: HLX208; Subjects will receive treatment HLX208 900 mg in the fed state followed by 7 days washout ，then receive treatment HLX208 900 mg in the fast state.; Drug: HLX208; 450 mg; Drug: HLX208; 900 mg
Experimental: HLX208 + Itraconazole group	Drug: HLX208; Subjects will receive treatment HLX208 900 mg in the fast state followed by 7 days washout ，then receive treatment HLX208 900 mg in the fed state; Drug: HLX208; Subjects will receive treatment HLX208 900 mg in the fed state followed by 7 days washout ，then receive treatment HLX208 900 mg in the fast state.; Drug: HLX208; 450 mg; Drug: HLX208; 900 mg; Drug: Itraconazole 200 mg; 200 mg
Experimental: HLX208 + rifampicin group	Drug: HLX208; Subjects will receive treatment HLX208 900 mg in the fast state followed by 7 days washout ，then receive treatment HLX208 900 mg in the fed state; Drug: HLX208; Subjects will receive treatment HLX208 900 mg in the fed state followed by 7 days washout ，then receive treatment HLX208 900 mg in the fast state.; Drug: HLX208; 450 mg; Drug: HLX208; 900 mg; Drug: Rifampicin; 600mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics parameter Cmax of HLX208	Cmax of HLX208	up to 48 hours
Pharmacokinetics parameter AUC0-t of HLX208	AUC0-t of HLX208	up to 48 hours
Pharmacokinetics parameter AUC0-inf of HLX208	AUC0-inf of HLX208	up to 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
other pharmacokinetics parameter Tmax of HLX208	Tmax of HLX208	up to 48 hours
other pharmacokinetics parameter Tlag of HLX208	Tlag of HLX208	up to 48 hours
other pharmacokinetics parameter t1/2 of HLX208	t1/2 of HLX208	up to 48 hours
other pharmacokinetics parameter CL/F of HLX208	CL/F of HLX208	up to 48 hours
other pharmacokinetics parameter Vd/F of HLX208	Vd/F of HLX208	up to 48 hours
other pharmacokinetics parameter MRT of HLX208	MRT of HLX208	up to 48 hours
other pharmacokinetics parameter %AUCex of HLX208	%AUCex of HLX208	up to 48 hours
The incidence and severity of adverse events/serious adverse events	Occurrence of Serious Adverse Event (SAE), Adverse Event (AE)	up to 17 days after the last dose

Collaborators and Investigators

• Sponsor: Shanghai Henlius Biotech

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2023
• Primary Completion (Actual): December 19, 2023
• Study Completion (Actual): December 19, 2023

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Leprostatic Agents; Hormone Antagonists; Cytochrome P-450 Enzyme Inducers; Antifungal Agents; Steroid Synthesis Inhibitors; Cytochrome P-450 CYP3A Inducers; Antitubercular Agents; 14-alpha Demethylase Inhibitors; Antibiotics, Antitubercular; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Rifampin; Itraconazole
• Other Study ID Numbers: HLX208-PK-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No