Trial record 1 of 2 for:
ALN-CC5
A Phase 1/2 Study of an Investigational Drug, ALN-CC5, in Healthy Adult Volunteers and Patients With PNH
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| ClinicalTrials.gov Identifier: NCT02352493 |
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Recruitment Status :
Completed
First Posted : February 2, 2015
Last Update Posted : September 6, 2017
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Sponsor:
Alnylam Pharmaceuticals
Information provided by (Responsible Party):
Alnylam Pharmaceuticals
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Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ALN-CC5 in healthy adult volunteers and subjects with PNH
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Paroxysmal Nocturnal Hemoglobinuria (PNH) | Drug: ALN-CC5 Drug: Sterile Normal Saline (0.9% NaCl) | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 62 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1/2 Single-ascending and Multiple-ascending Dose, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Subcutaneously Administered ALN-CC5 in Healthy Adult Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria |
| Study Start Date : | January 2015 |
| Actual Primary Completion Date : | April 2016 |
| Actual Study Completion Date : | August 2017 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Paroxysmal nocturnal hemoglobinuria
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: ALN-CC5 |
Drug: ALN-CC5
Single or multiple doses of ALN-CC5 by subcutaneous (sc) injection |
| Placebo Comparator: Sterile Normal Saline (0.9% NaCl) |
Drug: Sterile Normal Saline (0.9% NaCl)
calculated volume to match active comparator |
Primary Outcome Measures :
- The safety of ALN-CC5 evaluated by the proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs), and AEs leading to study drug discontinuation [ Time Frame: Part A: through day 70; Part B: through day 140; Part C: through day 140 ]
Secondary Outcome Measures :
- Profile of Pharmacokinetics (PK) of ALN-CC5 [ Time Frame: Part A: up to 56 days; Part B: up to 56, days; Part C: up to 85 days ]Cmax, tmax, Area Under Curve, t1/2
- The effect of ALN-CC5 on serum levels of complement activity [ Time Frame: Part A: through day 70; Part B: through day 140; Part C through day 140 ]
- The effect of ALN-CC5 on serum levels of C5 protein [ Time Frame: Part A: through day 70; Part B: through day 140; Part C through day 140 ]
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| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Adequate complete blood counts, liver and renal function
- 12-lead electrocardiogram (ECG) within normal limits
- Female subjects of child bearing potential agreeing to use a protocol specified method of contraception
- Male subjects agreeing to use protocol specified methods of contraception
- Willing to provide written informed consent and willing to comply with study requirements
Exclusion Criteria:
- Any uncontrolled or serious disease, or any medical or surgical condition, that may interfere with participation in the clinical study and/or put the subject at significant risk
- Received an investigational agent within 90 days before the first dose of study drug or are in follow-up of another clinical study
- History of multiple drug allergies or intolerance to subcutaneous injection
- Parts A and B of the study: Used prescription medications within 14 days or 7 half-lives of administration of the first dose of study drug.
- History of meningococcal infection
Information from the National Library of Medicine
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): NCT02352493
Locations
| Spain | |
| Clinical Trial Site | |
| Barcelona, Spain | |
| United Kingdom | |
| Clinical Trial Site | |
| Leeds, United Kingdom | |
| Covance Clinical Research Unit | |
| Leeds, United Kingdom | |
| Richmond Pharmacology | |
| London, United Kingdom | |
Sponsors and Collaborators
Alnylam Pharmaceuticals
Investigators
| Study Director: | Nader Najafian, MD | Alnylam Pharmaceuticals |
| Responsible Party: | Alnylam Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT02352493 History of Changes |
| Other Study ID Numbers: |
ALN-CC5-001 |
| First Posted: | February 2, 2015 Key Record Dates |
| Last Update Posted: | September 6, 2017 |
| Last Verified: | September 2017 |
Keywords provided by Alnylam Pharmaceuticals:
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PNH RNAi therapeutic |
Additional relevant MeSH terms:
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Hemoglobinuria Hemoglobinuria, Paroxysmal Proteinuria Urination Disorders Urologic Diseases Urological Manifestations |
Signs and Symptoms Anemia, Hemolytic Anemia Hematologic Diseases Myelodysplastic Syndromes Bone Marrow Diseases |