Investigation of safety, tolerability and pharmacokinetic properties of single subcutaneous doses of NNC0194-0499 in Japanese and non-Asian male subjects

JRCT ID: jRCT2071200100

Registered date:19/02/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: non-alcoholic steatohepatitis
• Date of first enrollment: 01/02/2021
• Target sample size: 42
• Study type: Interventional

Intervention(s)

Single dose of NNC0194-0499or placebo
Screening visit, in-house treatment (5 nights) and follow-up visit
Follow-up period afrer dosing is 35 days.
Trial duration is 38 - 64 days for each subject (depending on time of screening relative to dosing)

Outcome(s)

• Primary Outcome: Number of treatment emergent adverse events (TEAEs) [Time Frame: From Day 1 (pre-dose) until Day 36 (completion of the post-treatment period at follow-up)]

Secondary Outcome

1.AUC0-infinity,SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single s.c. administration
2. AUC0-tz,SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to the time for the last quantifiable sample after a single s.c. administration
3. AUC0-168h,SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to 168 hours after a single s.c. administration
4. Cmax,SD: The maximum concentration of NNC0194-0499 in serum after a single s.c. administration
5. tmax,SD: The time from dose administration to maximum concentration of NNC0194-0499 in serum after a single s.c. administration
6. t1/2,SD: The terminal serum half-life of NNC0194-0499 after a single s.c. administration
7. CL/FSD: The apparent total serum clearance of NNC0194-0499 after a single s.c. administration
8. Vz/FSD: The apparent volume of distribution of NNC0194-0499 in the terminal phase
9. MRTSD: The mean residence time of NNC0194-0499 after a single s.c. administration

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 55age old
• Gender: Male

Include criteria

1. For Japanese subjects only, both parents of Japanese descent. For non-Asian subjects only, both parents of non-Asian descent.
2. Body mass index (BMI) between 23.0 and 34.9 kg/m2 (both inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator.
3. Body weight >= 60 kg.
4. Considered by the investigator to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG, and clinical laboratory tests performed during the screening visit.

• Exclude criteria: Any disorder which in the opinion of investigator might jeopardise subject safety or compliance with the protocol.

Related Information

• Primary Sponsor: Sudoh Yuki
• Secondary ID(s): NCT04722653