5015192
Last Update Posted: 2025-02-19
Recruiting has ended
All Genders accepted | 18 Years-45 Years |
55 Estimated Participants | No Expanded Access |
Interventional Study | Accepts healthy volunteers |
Single Ascending Dose Study of NH102 in Healthy Subjects
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of NH102 when administered as single oral dose at escalating dose levels in healthy participants.
The drug being tested in this study is called NH102. NH102 is being tested to treat people who have depression. This study will look at the safety, tolerability and PK of NH102 in healthy participants.
The study may enroll up to 72 participants. Participants will be randomly assigned within each cohort to receive NH102 or placebo which will remain undisclosed to the participants and study doctor during the study (unless there is an urgent medical need). Each cohort will enroll 12 participants,which including 2 sentries (all were male, one receive NH102 and the other receive placebo) and 10 subjects(4 males and 4 females receive NH102 and 1 male and 1 female receive placebo). Participants enrolled in Cohort 1 to 6 will receive NH102 3mg, 9mg, 20mg, 40mg, 60mg and 80 mg or NH102 placebo-matching tablet. 2 sentries in all cohorts can be administered at the same time, and the remaining subjects of the same cohort can be administered only after observation for at least 24 hours and initial safety confirmation.
Eligibility
Relevant conditions:
Depression
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
Inclusion criteria
Exclusion criteria
locations
Contact Information
Overall Contact
Data sourced from ClinicalTrials.gov