A First in Human Study to Assess the Safety,Tolerability and Pharmacokinetics of ONO-2808 in Healthy Participants

• Status: Recruiting
• Trial end date: 2021-08-29
• Target enrollment: 0
• Participant gender: All

Summary

This is a first in human study to determine the safety, tolerability and pharmacokinetics of ONO-2808 in healthy adult participants. The study will be conducted in 4 parts: Part A, a single-ascending dose part with an assessment of the potential food effects in non-Japanese adult participants; Part B, a single-dose part to assess the effect of age in non-Japanese elderly participants; Part C, a multiple-ascending dose part with ONO-2808 administered to non-Japanese adult participants; and Part D, a single and multiple doses part to assess the ethnicity difference between Japanese and non-Japanese healthy participants.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ono Pharmaceutical Co. Ltd
• Collaborator: Parexel

Criteria

Inclusion Criteria:

1. Able to provide fully informed written consent.

2. 18-55 years (Part A & C), or ≥65 years (Part B) or 20-55 years (Part D).

3. Non-Japanese male and female participants (Women of non-child bearing potential (WONCBP)) (Part A, B & C) or male and female participants (WONCBP) of Japanese ethnicity (Part D).

4. Agree to use an effective method of contraception.

5. No clinically significant medical history and no abnormal physical examination, laboratory profiles, vital signs or ECG abnormalities, based on the Screening examination.

6. Body mass index of ≥18.5 to <30 kg/m2 and a body weight of at least 50 kg for males and 45 kg for females to a maximum of 100 kg, at the time of screening.

Exclusion Criteria:

1. History or presence of clinically significant medical, surgical or psychiatric condition (including history of suicidal behaviour) or objection by General Practitioner (GP) to participant entering trial.

2. Sensitivity to the study drug.

3. Female who is pregnant or lactating or of childbearing potential.

4. History or presence of alcoholism or drug/chemical/substance abuse.

5. Use of any medication which may affect ONO-2808 pharmacokinetics or pharmacodynamics

6. Current smoker or has smoked (including use of tobacco and/or nicotine-containing products) in the previous 3 months

7. Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).

8. Vital signs and supine resting blood pressure outside the acceptable normal range

9. Participants who are not willing to eat a high fat breakfast