Safety, Tolerability and Pharmacokinetics of ARCT-810 in Healthy Adult Subjects
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|ClinicalTrials.gov Identifier: NCT04416126|
Recruitment Status : Completed
First Posted : June 4, 2020
Last Update Posted : December 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ornithine Transcarbamylase Deficiency||Biological: ARCT-810 Other: Placebo||Phase 1|
This is a single ascending dose study of ARCT-810 in which approximately 30 subjects are planned to be enrolled. The length of each study participant is approximately 8 weeks from screening to last study visit.
Study participants will be allocated to one of the five different study groups (also called cohorts), to test different doses of ARCT-810. There will be 6 participants in each group. Within each cohort, subjects will be randomized 2:1 to receive ARCT-810 or placebo as an IV infusion.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Double blinded, Placebo Controlled|
|Official Title:||A Phase 1 Randomized, Double Blinded, Placebo Controlled, Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single Doses of ARCT-810 in Healthy Adult Subjects|
|Actual Study Start Date :||June 1, 2020|
|Actual Primary Completion Date :||December 9, 2020|
|Actual Study Completion Date :||December 9, 2020|
Ascending single doses of ARCT-810 administered intravenously
ARCT-810 is an investigational medicinal product comprising OTC mRNA formulated in a lipid nanoparticle (LNP) under development.
Placebo Comparator: Placebo
Single doses of 0.9% Saline administered intravenously
The placebo for this study is 0.9% sterile saline.
- Incidence, severity and dose-relationship of AEs [ Time Frame: 4 weeks ]Safety and tolerability of ARCT-810 assessed by determining the incidence, severity and dose-relationship of AEs by dose
- Number of participants with changes in plasma pharmacokinetic parameters after single dose of ARCT-810 [ Time Frame: Up to 15 days ]The plasma pharmacokinetics (concentration-time results) of ARCT-810 will be assessed following single dose
- Number of participants with changes in urine pharmacokinetic parameters after single dose of ARCT-810 [ Time Frame: Up to 24 hours ]The urine pharmacokinetics (concentration-time results) of ARCT-810 will be assessed following single dose
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04416126
|Auckland Clinical Studies (ACS) Ltd.|
|Auckland, New Zealand|
|Principal Investigator:||Christian Schwabe, MD||Auckland Clinical Studies (ACS) Ltd.|