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NCT03172208 · ClinicalTrials.gov registry record · Phase 1
Caplacizumab Single and Multiple Dose Study in Healthy Japanese and White Subjects.
A Phase 1 study of Healthy Volunteers, sponsored by Ablynx, a Sanofi company.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT03172208 is a Phase 1 study of Healthy Volunteers that has completed, run by Ablynx, a Sanofi company. The registered enrollment target is 60 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03172208, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Ablynx, a Sanofi company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary objective: To assess the safety and tolerability of single ascending intravenous (i.v.) doses, a single subcutaneous (s.c.) dose of caplacizumab (Part I), and multiple s.c. doses of caplacizumab (Part II) in Japanese subjects. Secondary objectives: * To compare the pharmacokinetic (PK) and pharmacodynamic (PD) profiles (total vWF:Ag concentration levels \[vWF:Ag\], coagulation factor VIII \[FVIII:C\], and ristocetin cofactor activity \[RICO\]) after single i.v. or s.c. administration of caplacizumab in Japanese and White subjects. * To evaluate the immunogenicity of caplacizumab (anti-drug antibodies \[ADA\]) in Japanese subjects.
Conditions Studied
Interventions
- BIOLOGICAL Caplacizumab Dose 1 iv (single-dose)
- BIOLOGICAL Caplacizumab Dose 2 iv (single-dose)
- BIOLOGICAL Caplacizumab Dose 2 sc (single-dose)
- BIOLOGICAL Caplacizumab Dose 2 sc (multiple-dose)
- OTHER Placebo iv (single-dose)
Study Locations (1)
California
- Investigator Site - Glendale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-06-05 |
| Est. Completion | 2017-10-19 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03172208
The ClinicalTrials.gov registry entry for NCT03172208 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (88% lower). The listed sponsor is Ablynx, a Sanofi company, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 5 interventions - of which Caplacizumab Dose 1 iv (single-dose) is the first listed.
NCT03172208 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03172208 about?
NCT03172208 is a clinical study titled "Caplacizumab Single and Multiple Dose Study in Healthy Japanese and White Subjects.". Primary objective: To assess the safety and tolerability of single ascending intravenous (i.v.) doses, a single subcutaneous (s.c.) dose of caplacizumab (Part I), and multiple s.c. doses of caplacizumab (Part II) in Japanese subjects. Secondary objectives: * To compare the pharmacokinetic (PK) an...
What is the current status of trial NCT03172208?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2017-06-05. Estimated completion is 2017-10-19.
What conditions does trial NCT03172208 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT03172208?
The interventions under investigation include: Caplacizumab Dose 1 iv (single-dose) (BIOLOGICAL), Caplacizumab Dose 2 iv (single-dose) (BIOLOGICAL), Caplacizumab Dose 2 sc (single-dose) (BIOLOGICAL), Caplacizumab Dose 2 sc (multiple-dose) (BIOLOGICAL), Placebo iv (single-dose) (OTHER).
Who is sponsoring clinical trial NCT03172208?
This trial is sponsored by Ablynx, a Sanofi company, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03172208 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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