NCT05715736CompletedPhase 1
Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APB-R3
A Phase 1, First-In-Human, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose of APB-R3 in Healthy Participants
Source: ClinicalTrials.gov · Last updated 8 Jan 2024
Brief summary (registry, in English)
This will be a single centre, Phase 1, First-In-Human, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose of APB-R3 in Healthy Participants.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 17 Aug 2022
- Start date
- 8 Mar 2023
- Primary completion date
- 19 Dec 2023
- Lead sponsor
- Syneos Health
- NCT number
- NCT05715736
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 31
- From 8 Mar 2023 to the primary completion date, 19 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Evidence of clinical significant hepatic or renal impairment
Lab values
- Clinically significant abnormal laboratory test results or positive serology test results for HBsAg, HCV antibody, or HIV antigen and antibody, or positive test results for COVID-19, or QuantiFERON®-TB test at screening.
Other
- Abnormal finding at physical examination
- Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.
Who the study is looking for
- Male or female, non-smoker, 18 to 60 years of age (both inclusive),
- Healthy as defined by:
- the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration in the opinion of the investigator.
- the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease in the opinion of the investigator.
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CMAX Clinical Research Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.