Clinical trial NCT05653479: Safety and Blood Levels After a Single Injection of UPB-101 in Healthy Japanese and Non-Japanese Non-East Asian Adults
Official title: A Randomized, Open-label, Parallel-group, Ethno-bridging Study Comparing the Pharmacokinetics and Safety of a Single Dose of UPB-101 in Healthy Japanese and Non-Japanese Non-East Asian Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Upstream Bio Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All treatment groups will enroll and run in parallel. Japanese participants will be enrolled and randomly assigned, on Day 1, to treatment groups 1, 2 or 3. NJNEA participants will be assigned to treatment group 4.
Primary purpose: TREATMENT

Brief summary: The goals of this clinical study are to characterize and compare the safety, tolerability, blood levels of UPB-101 when given to healthy Japanese and non-Japanese non-East Asian (NJNEA) adults. Eligible participants will be assigned to one of the 4 planned dosing treatment groups. Treatment groups 1, 2 and 3 will consist of Japanese adults who will be administered a single subcutaneous (SC) dose of UPB-101 (at 3 different strengths). Treatment group 4 will consist of NJNEA participants who will receive a single SC dose of UPB-101. All treatment groups will enroll and run in parallel.

Detailed description: This is a randomized, open-label, parallel group, ethno-bridging study comparing the pharmacokinetics and safety of a single dose of UPB-101 in healthy Japanese and NJNEA adults. The study will include 4 planned dosing treatment groups. Treatment groups 1, 2 and 3 will consist of Japanese adults who will be administered a single subcutaneous (SC) dose of UPB-101 (at 3 different strengths). Treatment group 4 will consist of NJNEA participants who will receive a single SC dose of UPB-101. All treatment groups will enroll and run in parallel. Japanese participants will be enrolled and randomized on Day 1 into treatment groups 1, 2 or 3 and NJNEA participants will be assigned to treatment group 4.

Eight participants will be enrolled per treatment group, all will receive a single dose of UPB-101. Thus, a total of 32 male and female participants will be enrolled in the study (24 Japanese participants in treatment groups 1-3 and 8 NJNEA participants in treatment group 4).

Eligibility criteria: Main Inclusion Criteria:

1. Male or female, aged ≥18 to ≤40 years at the date of signing informed consent
2. Body mass index (BMI) between 18 and 25 kg/m2
3. For Japanese (treatment groups 1, 2 and 3), participants must be:

   1. Born in Japan, holding a Japanese passport,
   2. Not living outside Japan for more than 5 years at the date of signing informed consent,
   3. Have all 4 grandparents Japanese

      For NJNEA treatment group 4, participants must be:
   4. Non-Japanese,
   5. Non-East Asian (Chinese, Korean, Mongolian or Taiwanese).
4. Healthy, as defined by:

   1. The absence of clinically significant illness and surgery within 4 weeks prior to dosing.
   2. The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
5. Agrees to follow the required contraceptive techniques.
6. Agrees not to donate sperm or ova from the time of the administration of study medication until three months later (120 days)

Main Exclusion Criteria:

1. Current or recurrent disease (or condition), which may put the participant at risk, influence the results of the study, or otherwise affect their ability to participate in the study.
2. Vital signs consistently outside the normal range at Screening or Day -1 and any other abnormal findings or vital signs, ECG, telemetry, physical examination or laboratory evaluation of blood and urine samples that the Investigator judges as likely to interfere with the study or pose an additional risk in participating.
3. Previous exposure or current infection with Hepatitis B, Hepatitis C, tuberculosis (TB), other active recent infection, or history of any untreated or unresolved infection, including parasitic infection.
4. Pregnant or breastfeeding female.
5. Previous exposure to the study drug or known allergy/sensitivity to any of its ingredients.
6. Positive test results for alcohol or drugs of abuse (including cotinine) at Screening or Day -1, or history or clinical evidence of substance and/or alcohol abuse within 2 years before screening.
7. Use of tobacco or other nicotine-containing products in any form within 3 months prior to Day 1.
8. Any recent vaccination, prescription or over-the-counter medication, including herbal remedies or dietary supplements.
9. Recent donation of blood or blood products.

Primary outcomes:
measure: Maximum Observed Concentration (Cmax) of UPB-101
timeFrame: Baseline through Day 85
measure: Time to Maximum Observed Concentration (Tmax) of UPB-101
timeFrame: Baseline through Day 85
measure: AUC From Time Zero up to the Last Quantifiable Concentration of UPB-101 (AUClast)
timeFrame: Baseline through Day 85
Secondary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events
timeFrame: Baseline through Day 85
measure: Immunogenicity Assessment of UPB-101 When Administered to Japanese and NJNEA Adults
timeFrame: Baseline through Day 85
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Richmond Pharmacology
Study officials:
affiliation: Upstream Bio
name: Chaim Brickman
role: STUDY_DIRECTOR
References: