A Study of IBI351 in Healthy Subjects

Innovent Biologics

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: IBI351; Drug: Itraconazole; Drug: Dextromethorphan

Study type: Interventional

Funder types: Industry

Identifiers

NCT05699993

CIBI351P003

Details and patient eligibility

About

This is an open-label, two-cycle clinical study to evaluate the drug interaction between itraconazole or dextromethorphan and IBI351 in healthy subjects. A total of two cohorts of 12 healthy male subjects were planned to be enrolled in each cohort.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Voluntarily sign the informed consent form before the trial, fully understand the content, process and possible adverse reactions of the trial, and be able to complete the study according to the requirements of the trial protocol.
2. Healthy male subjects aged 18 to 45 years (including both ends) at the time of signing informed consent.
3. Body weight is not less than 50 kg, and body mass index (BMI) is in the range of 19 ~ 26 kg/m2 (including both ends).
4. Physical examination, vital signs, routine laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function), thyroid function, 12-lead electrocardiogram, chest CT, abdominal ultrasound (hepatobiliary, pancreatic, spleen and kidney), echocardiography (only applicable to Cohort 1 subjects) showed no abnormalities; or abnormal test results but judged as normal or clinically insignificant by the investigator.

Exclusion criteria

1. have taken any products containing alcohol or have a positive alcohol breath test (≥ 20 mg/100 ml) within 24 hours before taking study medication.
2. hepatitis B surface antigen HBsAg positive.
3. hepatitis C virus antibody positive.
4. positive AIDS antigen/antibody or Treponema pallidum antibody.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

IBI351+ itraconazole

Other group

Description:

Enrolled subjects were treated with IBI351 on an empty stomach on Day 1. Itraconazole was administered orally once daily after a standardized meal from Day 3 to Day 6. IBI351 and itraconazole were administered simultaneously on an empty stomach on Day 7. On Day 8, itraconazole was orally administered once after a standard meal.

Treatment:

Drug: IBI351

Drug: Itraconazole

IBI351+ dextromethorphan

Other group

Description:

Enrolled subjects were orally administered dextromethorphan on an empty stomach on Day 1. IBI351 and dextromethorphan were orally administered simultaneously on an empty stomach on Day 3, followed by IBI351 12 hours later.

Treatment:

Drug: IBI351

Drug: Dextromethorphan