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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004262-17 | EudraCT Number |
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Study in healthy subjects to examine the safety and tolerability of ACT-1004-1239 given as multiple, gradually increasing doses and to examine the effects of ACT-1004-1239 on the body and the way the body takes up, distributes, and gets rid of ACT-1004-1239
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACT-1004-1239 Dose level 1 (30 mg) to 5 | Experimental | Each dose level will be investigated in a group of 10 male and female subjects (ratio 1:1, male:female), with 8 subjects being administered ACT-1004-239 and 2 subjects matching placebo (ratio 1:1, male:female). Sentinel dosing will be applied at each dose level, i.e., in each group two subjects (ratio 1:1, male:female) will initially receive study treatment (1 on active treatment and 1 on placebo). |
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| Placebo | Placebo Comparator | Each dose level will be investigated in a group of 10 male and female subjects (ratio 1:1, male:female), with 8 subjects being administered ACT-1004-239 and 2 subjects matching placebo (ratio 1:1, male:female). Sentinel dosing will be applied at each dose level, i.e., in each group two subjects (ratio 1:1, male:female) will initially receive study treatment (1 on active treatment and 1 on placebo). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT-1004-1239 | Drug | ACT-1004-1239 administered as hard capsules for oral use. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent (serious) adverse events | From first study treatment administration up to End of Study (EOS). Duration: up to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Idorsia Pharmaceuticals Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BlueClinical Phase 1 Hospital de Prelado | Porto | 4250-449 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33595155 | Derived | Pouzol L, Baumlin N, Sassi A, Tunis M, Marrie J, Vezzali E, Farine H, Mentzel U, Martinic MM. ACT-1004-1239, a first-in-class CXCR7 antagonist with both immunomodulatory and promyelinating effects for the treatment of inflammatory demyelinating diseases. FASEB J. 2021 Mar;35(3):e21431. doi: 10.1096/fj.202002465R. |
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| Placebo | Drug | Matching placebo administered as hard capsules for oral use. |
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| ID | Term |
|---|---|
| C000720621 | ACT-1004-1239 |
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