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ALXN1007 · 2 trials · 2 indications
Safety and tolerability of a single dose of ALXN1007 assessed by physical exam, vital signs, ECG, immunogenicity, lab analysis and adverse events.
| Arm | Type | Description |
|---|---|---|
| ALXN1007 | EXPERIMENTAL | Infusion of ALXN1007 |
| placebo | PLACEBO_COMPARATOR | Infusion placebo |
| Cohort 1 | ACTIVE_COMPARATOR | 0.06 mg/kg ALXN1007 |
| Cohort 2 | ACTIVE_COMPARATOR | 0.1 mg/kg ALXN1007 |
| Cohort 3 | ACTIVE_COMPARATOR | 0.3 mg/kg ALXN1007 |
| Cohort 4 | ACTIVE_COMPARATOR | 1.0 mg/kg ALXN1007 |
| Cohort 5 | ACTIVE_COMPARATOR | 3.0 mg/kg ALXN1007 |
| Cohort 6 | ACTIVE_COMPARATOR | 6.0 mg/kg ALXN1007 |
| Cohort 7 | ACTIVE_COMPARATOR | 10.0 mg/kg ALXN1007 |
| Name | Type | Description |
|---|---|---|
| ALXN1007 | DRUG | - |
| Placebo | OTHER | Single dose, IV |
Inclusion Criteria: Healthy male or female (not of childbearing potential) subjects ≥25 and ≤55 years old. 2\. QTcF ≤450 msec and ≤470 for females. 3. Willing and able to give written informed consent and comply with the study visit schedule. 4\. Male subject and his female spouse/partner who is ...
ALXN1007 is an investigational small molecule developed by AstraZeneca PLC. It has been studied in Phase 1 clinical trials in healthy adult volunteers, and no specific disease indication has been disclosed for the program. Both completed trials enrolled healthy subjects rather than patients.
ALXN1007 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. The company sponsored the Phase 1 clinical program evaluating the compound in healthy volunteers in the United States.
ALXN1007 is in Phase 1 development. Two Phase 1 trials have been completed, and no later-stage studies have been registered. The compound remains investigational and has not been approved by the FDA for any indication.
ALXN1007 has been evaluated in two completed Phase 1 trials: NCT01883544, which assessed safety, tolerability, pharmacokinetics, and pharmacodynamics in 16 healthy subjects, and NCT01454986, which studied safety, tolerability, pharmacokinetics, and pharmacodynamics in 64 healthy subjects. Both were conducted in the United States.
Both ALXN1007 Phase 1 trials were randomized, double-blind, and active-controlled studies in healthy male and female volunteers aged 25 years and older. Together they enrolled 80 subjects. NCT01454986 enrolled 64 participants, and NCT01883544 enrolled 16.