A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multi-Part, Single and Multiple Ascending Dose Study of JX09 in Healthy Adult Participants
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This is a phase 1, randomized, double-blind, placebo-controlled, multi-part, single and multiple ascending dose study in healthy adult to test the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of JX09 when administered to healthy adult subjects.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:
• Male or female aged 18 to 55 years (inclusive)
• In good health as deemed by the Investigator through a medical evaluation, including medical history, physical examination, and laboratory tests
• Body mass index (BMI) between 18 and 32 kg/m2, with a minimum weight of 50 kg at Screening
Locations
Other Locations
Australia
Nucleus Network Pty Ltd
RECRUITING
Melbourne
Contact Information
Primary
Cherry Dong
Cherry.dong@jixingbio.com
86-21-8031 1808
Backup
Yinghua Wang
Yinghua.wang@jixingbio.com
86-21-8031 1808
Time Frame
Start Date: 2024-01-18
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 92
Treatments
Experimental: Ascending Single Doses
48 participants, 6 single ascending dose (SAD) cohorts (Cohorts 1 to 6). Within each cohort, 8 participants will be randomized in a 6:2 ratio, 6 participants receiving JX09 and 2 receiving placebo
Experimental: Ascending Multiple Doses
32 participants, 4 multiple ascending dose (MAD) cohorts (Cohorts 7 to 10). Within each cohort, 8 participants will be randomized in a 6:2 ratio, 6 participants receiving JX09 and 2 receiving placebo
Experimental: Food Effect
12 participants,1 single-dose food effect (FE) cohort (Cohort 11), open-label, two-sequence, two-period, crossover design, participants will be randomly assigned to 1 of the 2 crossover sequences
Related Therapeutic Areas
Sponsors
Leads: Ji Xing Pharmaceuticals Australia Pty Ltd
Collaborators: Novotech (Australia) Pty Limited