A Study to Evaluate the Food Effect on RNK08954 in Healthy Participants, and the Mass Balance Study of [14C]RNK08954 in Healthy Adult Male Subjects

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorRanok Therapeutics (Hangzhou) Co., Ltd.

About this trial

An Study of Orally Administered RNK08954 in Healthy Adult Subjects to Determine the Effect of Food on the Pharmacokinetics of RNK08954,Mass Balance Study of \[14C\] RNK08954 in Chinese Healthy Adult Male Subjects

Eligibility criteria

Qualifiers

Healthy, adult, male or female, 18-45 years of age, inclusive, at the screening visit.

Male participants must have a body weight of no less than 50 kg, and female participants must have a body weight of no less than 45 kg. The Body mass index (BMI) should be between 19 and 26 kg/m² (inclusive).

Must follow protocol specified contraception guidance.

Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

Disqualifiers

Clinically significant abnormalities found in comprehensive physical examinations, vital signs, laboratory tests, 12-lead electrocardiogram, chest X-ray, etc.

Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or treponema pallidum antibody.

Individuals with allergic constitution.

Any history of clinically significant diseases or conditions that, in the investigator's judgment, may affect the trial results.

Trial design

Treatments tested in this trial

  • RNK08954

Treatment groups

24 Participants
are divided into 2 treatment groups