Relative Bioavailability Study of HR19042 in Healthy Subjects

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Primary IgA Nephropathy; Autoimmune Hepatitis

Treatments: Drug: HR19042 Capsule, Tarpeyo®, Budenofalk®

Study type: Interventional

Funder types: Industry

Identifiers

NCT06922305

HR19042-103

Details and patient eligibility

About

This is a single-center, randomized, open-label, three-period, dual Latin square crossover study.

Primary Objective：

1. To evaluate the oral relative bioavailability of HR19042 Capsules compared with budesonide delayed-release capsules (Tarpeyo®) and budesonide enteric-coated capsules (Budenofalk®).

   Secondary Objective

2. To assess safety following administration.

Enrollment: 18 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female subjects, ages 18 to 45, inclusive, at the time of informed consent.
2. Female subjects weigh ≥ 45 kg, male subjects weigh ≥ 50 kg, and BMI between 19.0 and 28.0 kg/m2, inclusive, at screening.
3. Understands the study procedures in the informed consent form ICF and be willing and able to comply with the protocol.

Exclusion criteria

1. Subject with any history of severe allergic or anaphylactic reactions to any allergen including drugs, or allergic disease diagnosed and treated by a physician.
2. Clinically significant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine or connective tissue diseases or disorders
3. Subject has positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or treponema pallidum antibody.
4. History of any gastrointestinal surgery or cholecystectomy that could impact the PK of study drugs.
5. Participated in other clinical trials within 3 months before screening or plan to participate in other clinical trials during this study.
6. Blood loss or blood donation of more than 300 mL within 3 months before screening, or intended to donate blood during the trial.
7. Those who have been vaccinated with vaccines within 3 month before screening or who have an intention to vaccinate during the trial.
8. Difficulty in venous blood sampling or fear of needles/blood.
9. Difficulty in swallowing capsules, or inability to comply with the provided diet and study-related instructions.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 6 patient groups

Sequence 1

Experimental group

Description:

Period 1: HR19042 Capsules Period 2: Tarpeyo® Period 3: Budenofalk®

Treatment:

Drug: HR19042 Capsule, Tarpeyo®, Budenofalk®

Sequence 2

Experimental group

Description:

Period 1: Tarpeyo® Period 2: Budenofalk® Period 3: HR19042 Capsules

Treatment:

Drug: HR19042 Capsule, Tarpeyo®, Budenofalk®

Sequence 3

Experimental group

Description:

Period 1: Budenofalk® Period 2: HR19042 Capsules Period 3: Tarpeyo®

Treatment:

Drug: HR19042 Capsule, Tarpeyo®, Budenofalk®

Sequence 4

Experimental group

Description:

Period 1: Tarpeyo® Period 2: HR19042 Capsules Period 3: Budenofalk®

Treatment:

Drug: HR19042 Capsule, Tarpeyo®, Budenofalk®

Sequence 5

Experimental group

Description:

Period 1: HR19042 Capsules Period 2: Budenofalk® Period 3: Tarpeyo®

Treatment:

Drug: HR19042 Capsule, Tarpeyo®, Budenofalk®

Sequence 6

Experimental group

Description:

Period 1: Budenofalk® Period 2: Tarpeyo® Period 3: HR19042 Capsules

Treatment:

Drug: HR19042 Capsule, Tarpeyo®, Budenofalk®