Study Summary
This trial tests if CD388 Injection is safe and tolerated when given as a single dose in healthy Japanese adults.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: At inpatient visits on Days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on Day 30 (±3 days), Day 45 (±3 days), Day 60 (±5 days), Day 90 (±7 days), and either Day 120 (±14 days) (Cohort 1 only) or Day 165 (±14 days) (Cohorts 2 and 3 only)
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Cohort 1
1 of 3
Cohort 2
1 of 3
Cohort 3
1 of 3
Experimental Treatment
27 Total Participants · 3 Treatment Groups
Primary Treatment: Cohort 1 · Has Placebo Group · Phase 1
Trial Logistics
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 65 · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Who meets the qualifications to participate in this research?
"This study demands 18 participants, aged between the ages of eighteen and sixty-five with healthy subjective states (hs). Additionally, they must be Japanese descending on both their maternal and paternal sides as reported by themselves. Willingness to provide written consent is also a necessity for those looking to join this clinical trial. Furthermore, male or female volunteers have to fulfill various requirements such as using contraception if capable of bearing children; being surgically sterile or past menopause in case incapable; having negative serum/urine pregnancy tests at screening & day -1 before first dose respectively; abstaining from donating eggs during the course & at least 7 months" - Anonymous Online Contributor
What is the size of the cohort involved in this research?
"Affirmative, the information accessible on clinicaltrials.gov indicates that this medical experiment is actively enrolling volunteers. First posted on October 18th 2022 and updated as recently as November 9th 2022, the trial seeks to recruit a total of eighteen patients from one site." - Anonymous Online Contributor
To what degree can Cohort 1 be potentially hazardous to those involved?
"Cohort 1's safety score was assessed at a value of one due to the limited research data available concerning its efficacy and security." - Anonymous Online Contributor
Does this clinical trial accept applicants who are over 50 years of age?
"As per the requirements of this clinical trial, only those aged 18 or above and 65 or under are welcome to participate." - Anonymous Online Contributor
Are there any vacancies for participants in this research endeavor?
"Affirmative. The public data found on clinicaltrials.gov confirms that this investigation, which was initially published on October 18th 2022, is actively recruiting participants. They are aiming to find 18 volunteers from one medical site in total." - Anonymous Online Contributor